Back to resultsPhase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)
Primary Purpose
Leukemia, Myeloid, Acute
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Cafusertib Hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring AML, phase1, MTD, Cafusertib
Eligibility Criteria
Inclusion Criteria:
- Signed written informed consent consistent with Chinese Good Clinical Practice.
- Male or female patients of age >/= 18 years at the time of informed consent.
- Patients with relapsed/refractory AML ineligible for conventional or intensive treatment.
- Eastern Cooperative Oncology Group performance status score 0 - 2 at screening.
- Life expectancy of at least 3 months.
- Adequate hepatic, renal and metabolic function parameters: Serum total bilirubin ≤1.5 x upper limit of normal, aspartate transaminase (AST) , alanine transaminase (ALT) ≤2.5 x upper limit of normal; Creatinine clearance rate ≥60ml/min, Serum creatinine ≤1.0 x upper limit of normal; Relatively normal ECG(electrocardiogram), QTc<450 ms(male) ,QTc<470 ms(female); LVEF>50%.
- Patients who can comply with the trial and follow-up procedures.
Exclusion Criteria:
- Patients had received cafusertib hydrochloride or other PLK inhibitors.
- Patients with APL.
- Patients with central nervous system leukemia.
- Need to continue using cytokine therapy at screening.
- Patients participated in other clinical trials within 4 weeks prior to enrollment.
- Patient with severe infection.
- Patients with myocardial infarction had occurred within six months prior to enrollment.
- Severe heart disease, including NYHA class II cardiac dysfunction and above.
- Patients with HIV infection or acute and chronic viral hepatitis.
- Severe gastrointestinal disorders (bleeding, infection, obstruction or greater than grade 1 diarrhea).
- A previous history of neurological or psychiatric disorders, including epilepsy or dementia.
- Concomitant medications with CYP3A4 inhibitors, inducers or substrates; Women pregnant or breast feeding.
- Subject is thought unfit for this study by investigator.
Sites / Locations
- Hospital of Blood Diseases, Chinese Academy of Medical SciencesRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cafusertib Hydrochloride + Cytarabine
Arm Description
Cafusertib (d1 and 15 - one hour iv.) + LD ARA C 2x20 mg/d s.c. Patient to receive escalating dose of cafusertib hydrochloride.
Outcomes
Primary Outcome Measures
MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities
Secondary Outcome Measures
Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, Cri; Partial remission (PR))
Incidence and intensity of adverse events graded according to CTCAE (version 4.0)
Incidence of dose limiting toxicity (DLT)
Pharmacokinetics of cafusertib
Full Information
NCT ID
NCT02140606
First Posted
May 12, 2014
Last Updated
May 13, 2014
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02140606
Brief Title
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)
Official Title
An Open Phase I Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous Cafusertib Hydrochloride in Combination With Subcutaneous Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
To investigate safety, tolerability of cafusertib combination with low dose cytarabine (LD-Ara-C) in Chinese patients with relapsed/refractory AML that are not eligible for conventional or intensive treatment. The dose of cafusertib will be escalated to determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of cafusertib in combination with LD-Ara-C in AML patients. At the same time, pharmacokinetic characteristics and preliminary efficacy of cafusertib will be observed in AML patients. To determine the recommended dosage regimen for phase II.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
AML, phase1, MTD, Cafusertib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
Cafusertib Hydrochloride + Cytarabine
Arm Type
Experimental
Arm Description
Cafusertib (d1 and 15 - one hour iv.) + LD ARA C 2x20 mg/d s.c. Patient to receive escalating dose of cafusertib hydrochloride.
Intervention Type
Drug
Intervention Name(s)
Cafusertib Hydrochloride
Intervention Description
Drug: Cafusertib Hydrochloride (d1 and 15) Cafusertib (d1 and 15 - one hour iv.v) Drug: Cytarabine Cytarabine 2 x 20 mg/d s.c. d1-15.
Primary Outcome Measure Information:
Title
MTD of cafusertib in combination with LDAraC based on the incidence of dose limiting toxicities
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Efficacy (complete remission, CR; complete remission with incomplete blood count recovery, Cri; Partial remission (PR))
Time Frame
minimum 4 weeks, maximum n.a.
Title
Incidence and intensity of adverse events graded according to CTCAE (version 4.0)
Time Frame
minimum 4 weeks, maximum n.a.
Title
Incidence of dose limiting toxicity (DLT)
Time Frame
4 weeks
Title
Pharmacokinetics of cafusertib
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed written informed consent consistent with Chinese Good Clinical Practice.
Male or female patients of age >/= 18 years at the time of informed consent.
Patients with relapsed/refractory AML ineligible for conventional or intensive treatment.
Eastern Cooperative Oncology Group performance status score 0 - 2 at screening.
Life expectancy of at least 3 months.
Adequate hepatic, renal and metabolic function parameters: Serum total bilirubin ≤1.5 x upper limit of normal, aspartate transaminase (AST) , alanine transaminase (ALT) ≤2.5 x upper limit of normal; Creatinine clearance rate ≥60ml/min, Serum creatinine ≤1.0 x upper limit of normal; Relatively normal ECG(electrocardiogram), QTc<450 ms(male) ,QTc<470 ms(female); LVEF>50%.
Patients who can comply with the trial and follow-up procedures.
Exclusion Criteria:
Patients had received cafusertib hydrochloride or other PLK inhibitors.
Patients with APL.
Patients with central nervous system leukemia.
Need to continue using cytokine therapy at screening.
Patients participated in other clinical trials within 4 weeks prior to enrollment.
Patient with severe infection.
Patients with myocardial infarction had occurred within six months prior to enrollment.
Severe heart disease, including NYHA class II cardiac dysfunction and above.
Patients with HIV infection or acute and chronic viral hepatitis.
Severe gastrointestinal disorders (bleeding, infection, obstruction or greater than grade 1 diarrhea).
A previous history of neurological or psychiatric disorders, including epilepsy or dementia.
Concomitant medications with CYP3A4 inhibitors, inducers or substrates; Women pregnant or breast feeding.
Subject is thought unfit for this study by investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianxiang Wang
Phone
022 239099120
Facility Information:
Facility Name
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
City
Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianxiang Wang
12. IPD Sharing Statement
Learn more about this trial
Phase I Trial to Investigate Cafusertib Hydrochloride in Combination With Low Dose Cytarabine in Chinese Patients With Acute Myeloid Leukaemia (AML)
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