Back to results

Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)

Primary Purpose

Myelodysplastic Syndrome, Myelodysplastic Syndromes

Status

Terminated

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

GSK2879552

Azacitidine

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring GSK2879552, Revised International Prognostic Scoring System (IPSS-R), azacitidine, hypomethylating agents, myelodysplastic syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

>=18 years of age and provided signed written informed consent
Subjects must have IPSS-R high or very high risk myelodysplastic syndromes (MDS) by World Health Organization (WHO) classification
Subjects must have failed hypomethylating treatment where "failure" is defined as: Progression (according to 2006 International Working Group [IWG] criteria) at any time after initiation of the hypomethylating treatment OR Failure to achieve complete or partial response or hematological improvement (HI) (according to 2006 IWG) after at least 4 cycles treatment OR Relapse after initial complete or partial response or HI (according to 2006 IWG criteria).
Subjects are not a candidate, or have failed allogeneic stem cell transplantation. Subjects who underwent allo-transplant in the past are eligible under following conditions: transplant was >2 year prior to enrolment, and no evidence of active graft-versus-host disease (GVHD)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Subjects must have a life expectancy of at least 12 weeks, in the opinion of the investigator.
Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia).
Adequate baseline organ function defined by: International Normalization Ratio (INR) and activated partial thromboplastin time (aPTT) <=1.3xupper limit of normal (ULN); platelet count (PLT) >=10,000 (transfusions permitted to bring PLT to >10,000); total bilirubin <=1.5xULN (Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome); Alanine transaminase (ALT) <=2.5xULN; creatinine <=1.5xULN OR calculated creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or measured from 24 hour urine >=50 milliliters (mL)/minute (min); and Ejection fraction >=lower limit of normal (LLN) by Echocardiogram (ECHO) or multigated acquisition scan (MUGA)
Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 7 days following the last dose of study treatment.
Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the administration of the first dose of study treatment until 3 months after the last dose of study treatment to allow for clearance of any altered sperm.

Exclusion Criteria:

AML according to world health organization (WHO) criteria (i.e. bone marrow blasts >20%)
Active hepatitis B or hepatitis C treatment
Baseline Montreal Cognitive Assessment (MOCA) score of 22 or lower
History of or concurrent malignancy of solid tumours, except for below:

Exception: Subjects who have been disease-free for 2 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible.

Prior treatment with temozolomide, dacarbazine or procarbazine
Prior treatment with poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors (example (e.g.), olaparib, veliparib [ABT-888])
Currently receiving other anti-cancer therapy (chemotherapy, radiation therapy, immuno- therapy, biologic therapy, hormonal therapy, surgery, and/or tumour embolization)
Received major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK2879552 administration
Evidence of severe or uncontrolled systemic diseases (e.g., severe/chronic infection, unstable or uncompensated respiratory, renal, or cardiac disease). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator
Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator's assessment)
Patients with any major bleeding current or within the past 4 weeks. (e.g. recent gastrointestinal [GI] hemorrhage or neurosurgery).
Administration of an investigational drug within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study treatment(s) in this study.
Cardiac abnormalities as evidenced by any of the following: clinically significant uncontrolled arrhythmias or uncontrolled hypertension; history or evidence of current >=Class II congestive heart failure as defined by New York Heart Association (NYHA); history of acute coronary syndromes (including unstable angina and myocardial infarction), coronary angioplasty, or stenting within the past 3 months; baseline Corrected QT (QTc) interval using Fridericia's formula >450 milliseconds (msec) or >480 msec in subjects with Bundle Branch Block. QTc value based on single or average of triplicate ECGs obtained over a brief recording period
Current use of a prohibited medication including anticoagulants or platelet inhibitors or expected to require any of these medications during treatment with the investigational drug
Consumption of Seville oranges, grapefruit, grapefruit hybrids, grapefruit juice, pommelos, or exotic citrus fruits, from 1 day prior to the first dose of study treatment(s) until the last dose of study drug
Lactating female
Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2879552 or lysine-specific demethylase 1 (LSD1) inhibitors that contraindicates their participation
Known hypersensitivity to azacitidine or mannitol

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm A: GSK2879552 monotherapy

Arm B: GSK2879552+Azacitidine combination therapy

Arm Description

Subjects will receive GSK2879552 2 milligrams (mg) once daily in each 28 day cycle.

Subjects will receive GSK2879552 starting at 1 mg once daily in each 28 day cycle and Azacitidine 75 mg/square meter (m2) from Day 1 to Day 7 of each 28 day cycle.

Outcomes

Primary Outcome Measures

Part 1: Number of Participants With Any Non-serious Adverse Event (Non-SAE), Serious AE (SAE), Dose Limiting Toxicities (DLT), Dose Reductions or Delays and Withdrawals Due to Toxicities

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or event associated with liver injury and impaired liver function were categorized as SAE. An event was considered a DLT if it occurred within the first 28 days of treatment, and met the DLT criteria unless it could be clearly established that the event was unrelated to treatment.

Part 1: Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Mean Corpuscular Volume (MCV) at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including MCV. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including MCH. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including MCHC and Hb. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Hematocrit at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including Hematocrit. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Erythrocytes at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including erythrocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Percent Reticulocytes at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including percent reticulocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Blast/Leukocytes at Indicated Time-points

Blood samples were collected from participants for evaluation of hematology parameters including blast/leukocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LDH) and Gamma Glutamyl Transferase (GGT) at Indicated Time-points

Blood samples were collected from participants for evaluation of clinical chemistry parameters including ALT, ALP, AST, LDH and GGT. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, Phosphate and Urea Nitrogen at Indicated Time-points

Blood samples were collected from participants for evaluation of clinical chemistry parameters including calcium, chloride, glucose, potassium, sodium, phosphate and urea nitrogen. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Albumin and Protein at Indicated Time Points

Blood samples were collected from participants for evaluation of clinical chemistry parameters including Albumin and Protein. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Partial Pressure Carbon Dioxide (pCO2) at Indicated Time Points

Blood samples were collected from participants for evaluation of clinical chemistry parameters including pCO2. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points

Vital signs including SBP and DBP were measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Heart Rate at Indicated Time-points

Vital signs including heart rate was measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Respiratory Rate at Indicated Time-points

Vital signs including respiratory rate was measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Body Temperature at Indicated Time-points

Vital signs including body temperature was measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate at Indicated Time-points

Single 12-lead ECG was obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and corrected QT (QTc) intervals. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTc Corrected by Bazett's Formula (QTcB) and QTc Corrected by Fridericia's Formula (QTcF) at Indicated Time-points

Single 12-lead ECG was obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Part 1: Number of Participants With Abnormal Findings During Physical Examination

A complete physical examination included, at a minimum, assessment of the Cardiovascular, Respiratory, Gastrointestinal and Neurological systems. A brief physical examination included, at a minimum assessments of the skin, lungs, cardiovascular system, and abdomen (liver and spleen). This analysis was planned but data was not captured in the database. Abnormal changes were captured as adverse events if they were clinically significant.

Part 2: Percentage of Participants With Investigator-assessed Best Response Assessed by Clinical Benefit Rate (CBR)

CBR was defined as the percentage of participants achieving a confirmed Complete Remission (CR) or Partial Remission (PR) or Marrow Complete Remission (mCR) or confirmed Hematologic Improvement (HI) or Stable Disease (SD) prior to new anti-cancer therapy and crossover on the All Treated Subjects Population. Participants with Not Evaluable or missing response were to be treated as non-responders. International Working Group (IWG) criteria, 2006 was to be used to evaluate response.

Part 2: Percentage of Participants With Investigator-assessed Best Response Assessed by Objective Response Rate (ORR)

Objective response rate was defined as the percentage of participants who achieved CR or PR or mCR or HI prior to new anti-cancer therapy on the All Treated Subjects Population. Participants with Not Evaluable or missing response were to be treated as non-responders. IWG criteria, 2006 was to be used to evaluate response.

Part 1: Change From Baseline in Total Bilirubin, Direct Bilirubin, Creatinine and Urate at Indicated Time Points

Blood samples were collected from participants for evaluation of clinical chemistry parameters including Total Bilirubin, Direct Bilirubin, Creatinine and urate. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was calculated by subtracting post-dose value from Baseline value.

Secondary Outcome Measures

Part 1: Percentage of Participants With Investigator-assessed Best Response Assessed by Clinical Benefit Rate (CBR)

Clinical Benefit Rate was defined as the percentage of participants achieving a confirmed Complete Remission (CR) or Partial Remission (PR) or Marrow Complete Remission (mCR) or confirmed Hematologic Improvement (HI) or Stable Disease (SD) prior to new anti-cancer therapy and crossover on the All Treated Subjects Population. Participants with Not Evaluable or missing response were treated as non-responders. International Working Group (IWG) criteria, 2006 was used to evaluate response.

Part 1: Percentage of Participants With Investigator-assessed Best Response Assessed by Objective Response Rate (ORR)

Objective Response Rate was defined as the percentage of participants who achieved Complete Remission (CR) or Partial Remission (PR) or Marrow Complete Remission (mCR) or confirmed Hematologic Improvement (HI) prior to new anti-cancer therapy on the All Treated Subjects Population. Participants with Not Evaluable or missing response were treated as non-responders. International Working Group (IWG) criteria, 2006 was used to evaluate response.

Part 1: Plasma Concentration of GSK2879552

Blood samples were collected at indicated time points to evaluate concentration of GSK2879552. Each Pharmacokinetic (PK) sample was collected as close as possible to the planned time relative to the dose (i.e., time zero) administered to the participant on PK days. PK Concentration Population consisted of all participants in the All Treated Subject Population for whom a blood sample for pharmacokinetics was obtained and analyzed.

Part 1: Plasma Concentration of Azacitidine

Blood samples were to be collected at indicated time points to evaluate concentration of Azacitidine.

Part 1: Duration of Response

Duration of response is defined as the subset of participants (responders) who show a response (CR, mCR, PR, or HI), the time from first documented evidence of response until the first documented sign of disease progression or death. If no disease progression or death, the DOR was to be censored at last disease assessment.

Part 1: Progression-free Survival

Progression-free survival (PFS) is defined as the time from first treatment dose until the first documented sign of disease progression or death. If the participant missed more than one visit prior to the date of documented events, PFS was censored at the last adequate assessment prior to missing. Otherwise, if the participant did not have a documented date of events, PFS was censored at the date of the last adequate assessment.

Part 1: Overall Survival

Overall survival (OS) is defined as the time from first treatment dose until death due to any reason. For the analysis of overall survival (OS), the last date of known contact was used for those participants who had not died at the time of analysis; such participants were considered censored.

Part 1: Proportion of Participants With Disease Progression to Acute Myeloblastic Leukemia (AML)

The proportion of participants with disease progression to AML is defined as the percentage of participants experiencing AML on the All Treated Subjects Population.

Part 1: Time to AML Progression

Time to AML progression is defined as the time from first treatment dose until AML progression or crossover if using the All Treated Subjects Population. For the analysis of time to AML, if the participant did not experience AML, time to AML was censored at the last treatment prior to the initiation of anti-cancer therapy or crossover.

Part 1: Number of Participants With Documented Platelet and Red Blood Cell (RBC) Transfusions Per Month

Number of participants with documented platelet and RBC transfusions have been presented.

Part 2: Number of Participants With Any AEs and SAEs

Part 2: Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including platelets, neutrophils, monocytes, lymphocytes, leucocyte, eosinophils and basophils. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in MCV at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including MCV. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in MCH at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including MCH. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in MCHC and Hb at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including MCHC and Hb. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Hematocrit at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including Hematocrit. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Erythrocytes at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including erythrocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Percent Reticulocytes at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including percent reticulocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Blast/Leukocytes at Indicated Time-points

Blood samples were to be collected from participants for evaluation of hematology parameters including blast/leukocytes. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in ALT, ALP, AST, LDH and GGT at Indicated Time-points

Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including ALT, ALP, AST, LDH and GGT. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, Phosphate and Urea Nitrogen at Indicated Time-points

Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including Calcium, chloride, glucose, potassium, sodium, phosphate and urea nitrogen. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Total Bilirubin, Direct Bilirubin, Creatinine and Urate at Indicated Time Points

Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including Total Bilirubin, Direct Bilirubin, Creatinine and urate. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Albumin and Protein at Indicated Time Points

Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including Albumin and Protein. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in pCO2 at Indicated Time Points

Blood samples were to be collected from participants for evaluation of clinical chemistry parameters including pCO2. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in SBP and DBP at Indicated Time-points

Vital signs including SBP and DBP were to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Heart Rate at Indicated Time-points

Vital signs including heart rate was to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Respiratory Rate at Indicated Time-points

Vital signs including respiratory rate was to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in Body Temperature at Indicated Time-points

Vital signs including body temperature was to be measured after resting for at least 5 minutes in a semi-supine position. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in ECG Mean Heart Rate at Indicated Time-points

Single 12-lead ECG was to be obtained at designated time points during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals. Baseline was defined as the value obtained prior to first dosing (Day 1). Change from Baseline was to be calculated by subtracting post-dose value from Baseline value.

Part 2: Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time-points

Part 2: Number of Participants With Abnormal Findings During Physical Examination

Part 2: Plasma Clearance (CL/F) of GSK2879552

Blood samples were to be collected at indicated time points to evaluate CL/F of GSK2879552. Each PK sample was to be collected as close as possible to the planned time relative to the dose (i.e., time zero) administered to the participant on PK days.

Part 2: Duration of Response

Duration of response is defined as the time from first documented evidence of response until the first documented sign of disease progression or death. If no disease progression or death, the duration of response was to be censored at last disease assessment.

Part 2: Progression-free Survival

Progression-free survival is defined as the time from first treatment dose until the first documented sign of disease progression or death. If the participant missed more than one visit prior to the date of documented events, PFS was to be censored at the last adequate assessment prior to missing. Otherwise, if the participant did not have a documented date of events, PFS was to be censored at the date of the last adequate assessment.

Part 2: Overall Survival

Overall survival is defined as the time from first treatment dose until death due to any reason. For the analysis of overall survival, the last date of known contact was to be used for those participants who had not died at the time of analysis; such participants were to be considered censored.

Part 2: Percentage of Participants With Disease Progression to AML

The percentage of participants experiencing AML on the All Treated Subjects Population was to be presented.

Part 2: Time to AML Progression

Time to AML progression is defined as the time from first treatment dose until AML progression or crossover if using the All Treated Subjects Population. For the analysis of time to AML, if the participant did not experience AML, time to AML was to be censored at the last treatment prior to the initiation of anti-cancer therapy or crossover.

Part 2: Number of Participants With Documented Platelet and Red Blood Cell (RBC) Transfusions Per Month

Number of participants with documented platelet and RBC transfusions were to be presented.

Full Information

NCT ID

NCT02929498

First Posted

September 27, 2016

Last Updated

April 23, 2019

Sponsor

GlaxoSmithKline

Collaborators

Parexel

1. Study Identification

Unique Protocol Identification Number

NCT02929498

Brief Title

Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)

Official Title

A Phase I/II, Open-label, 2 Arm Study to Investigate the Safety, Clinical Activity, Pharmacokinetics and Pharmacodynamics of GSK2879552 Administered Alone or in Combination With Azacitidine, in Adult Subjects With IPSS-R High and Very High Risk Myelodysplastic Syndromes (MDS) Previously Treated With Hypomethylating Agents (HMA)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

The risk benefit in the study population does not favor continuation of the study

Study Start Date

July 31, 2017 (Actual)

Primary Completion Date

January 31, 2018 (Actual)

Study Completion Date

January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

Collaborators

Parexel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase I/II, open-label, 2 arm study to evaluate the safety and clinical activity of GSK2879552 alone, or in combination with azacitidine in subjects with MDS. The study consisted of 2 parts. The objective of Part 1 is to determine the recommended phase 2 dose (RP2D) of GSK2879552 administered alone and in combination with azacitidine in adult subjects with high risk MDS previously treated with HMA. The objective of Part 2 is to evaluate clinical activity after treatment with GSK2879552, alone or in combination with azacitidine, in adult subjects with high risk MDS previously treated with HMA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndrome, Myelodysplastic Syndromes

Keywords

GSK2879552, Revised International Prognostic Scoring System (IPSS-R), azacitidine, hypomethylating agents, myelodysplastic syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: GSK2879552 monotherapy

Arm Type

Experimental

Arm Description

Subjects will receive GSK2879552 2 milligrams (mg) once daily in each 28 day cycle.

Arm Title

Arm B: GSK2879552+Azacitidine combination therapy

Arm Type

Experimental

Arm Description

Subjects will receive GSK2879552 starting at 1 mg once daily in each 28 day cycle and Azacitidine 75 mg/square meter (m2) from Day 1 to Day 7 of each 28 day cycle.

Intervention Type

Drug

Intervention Name(s)

GSK2879552

Intervention Description

GSK2879552 will be administered orally as continuous daily dosing.

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

Azacitidine will be administered at 75 mg/m2 from Day 1 to Day 7 of each 28 day cycle by intravenous (iv) infusion or subcutaneous (sc) injection.

Primary Outcome Measure Information:

Title

Part 1: Number of Participants With Any Non-serious Adverse Event (Non-SAE), Serious AE (SAE), Dose Limiting Toxicities (DLT), Dose Reductions or Delays and Withdrawals Due to Toxicities

Description

Time Frame

Up to 2 years

Title

Part 1: Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Mean Corpuscular Volume (MCV) at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Mean Corpuscular Hemoglobin (MCH) at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Mean Corpuscular Hemoglobin Concentration (MCHC) and Hemoglobin (Hb) at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Hematocrit at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Erythrocytes at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Percent Reticulocytes at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Blast/Leukocytes at Indicated Time-points

Description

Time Frame

Baseline and Day 1 of Cycle 1 (Cycle of 28 days)

Title

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, Phosphate and Urea Nitrogen at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Albumin and Protein at Indicated Time Points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Partial Pressure Carbon Dioxide (pCO2) at Indicated Time Points

Description

Time Frame

Baseline and Day 1 of Cycle 1 (cycle of 28 days)

Title

Part 1: Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Heart Rate at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Respiratory Rate at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Body Temperature at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1 (Days 7, 15), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in Electrocardiogram (ECG) Mean Heart Rate at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1 (Days 1, 7), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTc Corrected by Bazett's Formula (QTcB) and QTc Corrected by Fridericia's Formula (QTcF) at Indicated Time-points

Description

Time Frame

Baseline and Cycle 1 (Days 1,7), Cycle 2 (Day 1), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Title

Part 1: Number of Participants With Abnormal Findings During Physical Examination

Description

Time Frame

Up to 2 years

Title

Part 2: Percentage of Participants With Investigator-assessed Best Response Assessed by Clinical Benefit Rate (CBR)

Description

Time Frame

Up to 2.5 years

Title

Part 2: Percentage of Participants With Investigator-assessed Best Response Assessed by Objective Response Rate (ORR)

Description

Time Frame

Up to 2.5 years

Title

Part 1: Change From Baseline in Total Bilirubin, Direct Bilirubin, Creatinine and Urate at Indicated Time Points

Description

Time Frame

Baseline and Cycle 1(Days 1, 7, 15, 22), Cycle 2 (Days 1, 7, 15 ,22), Cycle 3 (Day 1), Cycle 4 (Day 1), Cycle 5 (Day 1) (each cycle of 28 days)

Secondary Outcome Measure Information:

Title

Part 1: Percentage of Participants With Investigator-assessed Best Response Assessed by Clinical Benefit Rate (CBR)

Description

Time Frame

Up to 2 years

Title

Part 1: Percentage of Participants With Investigator-assessed Best Response Assessed by Objective Response Rate (ORR)

Description

Time Frame

Up to 2 years

Title

Part 1: Plasma Concentration of GSK2879552

Description

Time Frame

Cycle 1, Day 1: pre-dose, 0.5, 1, 3 hour; pre-dose on Days 2,4; Day 7: pre-dose, 0.5, 1, 3 hour; Day 15: pre-dose, 0.5-1 hour post-dose; pre-dose on Day 22; Cycle 2: pre-dose on Days 1, 7, 15, 22; Pre-dose on Day 1 of Cycles 3,4,5 (each cycle of 28 days)

Title

Part 1: Plasma Concentration of Azacitidine

Description

Blood samples were to be collected at indicated time points to evaluate concentration of Azacitidine.

Time Frame

Title

Part 1: Duration of Response

Description

Time Frame

Up to 2 years

Title

Part 1: Progression-free Survival

Description

Time Frame

Up to 2 years

Title

Part 1: Overall Survival

Description

Time Frame

Up to 2 years

Title

Part 1: Proportion of Participants With Disease Progression to Acute Myeloblastic Leukemia (AML)

Description

The proportion of participants with disease progression to AML is defined as the percentage of participants experiencing AML on the All Treated Subjects Population.

Time Frame

Up to 2 years

Title

Part 1: Time to AML Progression

Description

Time Frame

Up to 2 years

Title

Part 1: Number of Participants With Documented Platelet and Red Blood Cell (RBC) Transfusions Per Month

Description

Number of participants with documented platelet and RBC transfusions have been presented.

Time Frame

Up to 2 years

Title

Part 2: Number of Participants With Any AEs and SAEs

Description

Time Frame

Up to 2.5 years

Title

Part 2: Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes, Leucocyte, Eosinophils and Basophils at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in MCV at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in MCH at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in MCHC and Hb at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Hematocrit at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Erythrocytes at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Percent Reticulocytes at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Blast/Leukocytes at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in ALT, ALP, AST, LDH and GGT at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Calcium, Chloride, Glucose, Potassium, Sodium, Phosphate and Urea Nitrogen at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Total Bilirubin, Direct Bilirubin, Creatinine and Urate at Indicated Time Points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Albumin and Protein at Indicated Time Points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in pCO2 at Indicated Time Points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in SBP and DBP at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Heart Rate at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Respiratory Rate at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in Body Temperature at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in ECG Mean Heart Rate at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Change From Baseline in ECG PR Interval, QRS Duration, QT Interval, QTcB and QTcF at Indicated Time-points

Description

Time Frame

Baseline and up to 2.5 years

Title

Part 2: Number of Participants With Abnormal Findings During Physical Examination

Description

Time Frame

Up to 2.5 years

Title

Part 2: Plasma Clearance (CL/F) of GSK2879552

Description

Time Frame

Cycle 1, Day 1: pre-dose, 0.5, 1, 3 hour; pre-dose on Day 4; Day 7: pre-dose, 0.5, 1, 3 hour; Day 15: pre-dose, 0.5-1 hour post-dose; pre-dose on Day 22; Cycle 2: pre-dose on Days 1, 7, 15, 22; Pre-dose on Day 1 of Cycles 3 to 1 (each cycle of 28 days)

Title

Part 2: Duration of Response

Description

Time Frame

Up to 2.5 years

Title

Part 2: Progression-free Survival

Description

Time Frame

Up to 2.5 years

Title

Part 2: Overall Survival

Description

Time Frame

Up to 2.5 years

Title

Part 2: Percentage of Participants With Disease Progression to AML

Description

The percentage of participants experiencing AML on the All Treated Subjects Population was to be presented.

Time Frame

Up to 2.5 years

Title

Part 2: Time to AML Progression

Description

Time to AML progression is defined as the time from first treatment dose until AML progression or crossover if using the All Treated Subjects Population. For the analysis of time to AML, if the participant did not experience AML, time to AML was to be censored at the last treatment prior to the initiation of anti-cancer therapy or crossover.

Time Frame

Up to 2.5 years

Title

Part 2: Number of Participants With Documented Platelet and Red Blood Cell (RBC) Transfusions Per Month

Description

Number of participants with documented platelet and RBC transfusions were to be presented.

Time Frame

Up to 2.5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: >=18 years of age and provided signed written informed consent Subjects must have IPSS-R high or very high risk myelodysplastic syndromes (MDS) by World Health Organization (WHO) classification Subjects must have failed hypomethylating treatment where "failure" is defined as: Progression (according to 2006 International Working Group [IWG] criteria) at any time after initiation of the hypomethylating treatment OR Failure to achieve complete or partial response or hematological improvement (HI) (according to 2006 IWG) after at least 4 cycles treatment OR Relapse after initial complete or partial response or HI (according to 2006 IWG criteria). Subjects are not a candidate, or have failed allogeneic stem cell transplantation. Subjects who underwent allo-transplant in the past are eligible under following conditions: transplant was >2 year prior to enrolment, and no evidence of active graft-versus-host disease (GVHD) Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Subjects must have a life expectancy of at least 12 weeks, in the opinion of the investigator. Able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. All prior treatment-related toxicities must be National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 4.0 <=Grade 1 at the time of enrollment (except for alopecia). Adequate baseline organ function defined by: International Normalization Ratio (INR) and activated partial thromboplastin time (aPTT) <=1.3xupper limit of normal (ULN); platelet count (PLT) >=10,000 (transfusions permitted to bring PLT to >10,000); total bilirubin <=1.5xULN (Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35% or subject has a diagnosis of Gilbert's syndrome); Alanine transaminase (ALT) <=2.5xULN; creatinine <=1.5xULN OR calculated creatinine clearance by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation or measured from 24 hour urine >=50 milliliters (mL)/minute (min); and Ejection fraction >=lower limit of normal (LLN) by Echocardiogram (ECHO) or multigated acquisition scan (MUGA) Women of childbearing potential must have a negative serum pregnancy test within 7 days of first dose of study treatment and agree to use effective contraception during the study and for 7 days following the last dose of study treatment. Men with a female partner of childbearing potential must have either had a prior vasectomy or agree to use effective contraception from the administration of the first dose of study treatment until 3 months after the last dose of study treatment to allow for clearance of any altered sperm. Exclusion Criteria: AML according to world health organization (WHO) criteria (i.e. bone marrow blasts >20%) Active hepatitis B or hepatitis C treatment Baseline Montreal Cognitive Assessment (MOCA) score of 22 or lower History of or concurrent malignancy of solid tumours, except for below: Exception: Subjects who have been disease-free for 2 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Prior treatment with temozolomide, dacarbazine or procarbazine Prior treatment with poly adenosine diphosphate (ADP) ribose polymerase (PARP) inhibitors (example (e.g.), olaparib, veliparib [ABT-888]) Currently receiving other anti-cancer therapy (chemotherapy, radiation therapy, immuno- therapy, biologic therapy, hormonal therapy, surgery, and/or tumour embolization) Received major surgery, radiotherapy, or immunotherapy within 4 weeks of GSK2879552 administration Evidence of severe or uncontrolled systemic diseases (e.g., severe/chronic infection, unstable or uncompensated respiratory, renal, or cardiac disease). Any serious and/or unstable pre-existing medical (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the Investigator Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator's assessment) Patients with any major bleeding current or within the past 4 weeks. (e.g. recent gastrointestinal [GI] hemorrhage or neurosurgery). Administration of an investigational drug within 14 days or 5 half-lives, whichever is shorter, preceding the first dose of study treatment(s) in this study. Cardiac abnormalities as evidenced by any of the following: clinically significant uncontrolled arrhythmias or uncontrolled hypertension; history or evidence of current >=Class II congestive heart failure as defined by New York Heart Association (NYHA); history of acute coronary syndromes (including unstable angina and myocardial infarction), coronary angioplasty, or stenting within the past 3 months; baseline Corrected QT (QTc) interval using Fridericia's formula >450 milliseconds (msec) or >480 msec in subjects with Bundle Branch Block. QTc value based on single or average of triplicate ECGs obtained over a brief recording period Current use of a prohibited medication including anticoagulants or platelet inhibitors or expected to require any of these medications during treatment with the investigational drug Consumption of Seville oranges, grapefruit, grapefruit hybrids, grapefruit juice, pommelos, or exotic citrus fruits, from 1 day prior to the first dose of study treatment(s) until the last dose of study drug Lactating female Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to GSK2879552 or lysine-specific demethylase 1 (LSD1) inhibitors that contraindicates their participation Known hypersensitivity to azacitidine or mannitol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

GSK Investigational Site

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

Facility Name

GSK Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19111

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28033

Country

Spain

Facility Name

GSK Investigational Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Safety, Clinical Activity, Pharmacokinetics (PK) and Pharmacodynamics Study of GSK2879552, Alone or With Azacitidine, in Subjects With High Risk Myelodysplastic Syndromes (MDS)

We'll reach out to this number within 24 hrs