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Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies

Primary Purpose

Advanced Nonhematological Malignancies, Non-Small Cell Lung Cancer, Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MLN8237 (Alisertib)
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Nonhematological Malignancies focused on measuring NSCLC, SCLC, HNSCC

Eligibility Criteria

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

Inclusion Criteria:

Each patient must meet all of the following inclusion criteria to be enrolled in the study:

  • 18 years or older
  • Histologically or cytologically confirmed metastatic and/or advanced solid tumor (Phase 1 only)
  • Phase 2 requires Non-small cell lung cancer (NSCLC); Small-cell lung cancer; Breast adenocarcinoma (female patients only); Squamous cell cancer of the head and neck (HNSCC); or Gastroesophageal adenocarcinoma
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse
  • Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
  • Voluntary written consent
  • Wiling to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
  • Measurable disease (Phase 2 only)

Exclusion Criteria:

Patients meeting any of the following exclusion criteria are not to be enrolled in the study:

  • Female patients who are pregnant or lactating
  • Serious medical or psychiatric illness that could interfere with protocol completion
  • Receipt of more than 2 previous cytotoxic chemotherapeutic regimens (4 previous regimens for breast cancer). There is no limit on the number of prior noncytotoxic therapies
  • Prior treatment with Aurora A-targeted agents, including MLN8237
  • Prior treatment with high-dose chemotherapy
  • Prior allogeneic bone marrow or other organ transplant
  • Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to first dose of MLN8237
  • Symptomatic brain metastasis
  • Radiotherapy to greater than 25% of bone marrow
  • Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
  • Myocardial infarction within 6 months of enrollment
  • Uncontrolled cardiovascular condition
  • Major surgery within 14 days of first dose of MLN8237
  • Active infection requiring systemic therapy, or other serious infection
  • Inability to swallow oral medication
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
  • Patients requiring full systemic anticoagulation
  • History of uncontrolled sleep apnea syndrome
  • Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 and during the study

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MLN8237 (Alisertib)

Arm Description

MLN8237 administered as an enteric-coated tablet (ECT)

Outcomes

Primary Outcome Measures

Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/cubic meter [cells/mm^3]) for >7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets <25,000 cells/mm3) for >7 days; Platelet count <10,000 cells/mm3; Grade 3 thrombocytopenia with clinically significant bleeding; Delay in initiation of the subsequent therapy cycle by >7 days due to treatment-related toxicity; >=Grade 3 nonhematological toxicity except >=Grade 3 nausea/emesis occurred in the absence of optimal antiemetic therapy; >=Grade 3 diarrhea occurred in the absence of optimal supportive therapy with loperamide/comparable antidiarrheal; Grade 3 fatigue for <1 week; Other Grade 3 nonhematological toxicity that could be safely, reliably controlled to <=Grade 2 with appropriate treatment.
Phase 2: Percentage of Participants With Objective Response
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.

Secondary Outcome Measures

Phase 2: Progression-free Survival (PFS)
PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.
Phase 2: Time to Disease Progression (TTP)
Time in days from start of study treatment to first documentation of objective tumor progression. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.
Phase 2: Duration of Response (DOR)
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response=(the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). CR: complete disappearance of all target lesions and non-target disease, except nodal disease; all nodes decreased to normal; no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. Tumor progression: >=20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); absolute increase of >=5 mm; appearance of >=1 new lesions is also considered progression. DOR calculated for the subgroup of participants with objective response.
Phase 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events and Serious Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Phase 1: Cmax- Maximum Observed Plasma Concentration for Alisertib
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Phase 1: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Phase 1: Terminal Phase Elimination Half-life (T1/2) for Alisertib
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Phase 1: Rac- Accumulation Ratio for Alisertib
Rac was estimated as a ratio of AUC (0-tau) at Day 7 and AUC (0-tau) at Day 1. Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Phase 1: Peak to Trough Ratio for Alisertib
Peak to trough ratio was estimated as a ratio of Cmax at Day 7 and the minimum observed plasma concentration (Ctrough) of alisertib at Day 7. Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Ctrough is the minimum plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Phase 1: Steady State Oral Clearance (CLss/F) for Alisertib
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-tau), expressed in liter per hour (L/hr).
Phase 2: Relationship Between Clinical Response and Molecular Markers of Response
In SCLC,chemo-sensitive/resistant population were analyzed;in breast cancers,ER2 and ER2 status were analyzed.HR+ =estrogen receptor-positive or progesterone receptor-positive. HER+ =human epidermal growth factor receptor 2 (HER2). Triple negative =negative for estrogen receptors, progesterone receptors, and HER2.Clinical response according to RECIST version 1.1. CR:complete disappearance of all target lesions,non-target disease,except nodal disease;all nodes decrease to normal (short axis <10 mm);no new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions (SLD);short axis was used in the sum for target nodes,longest diameter used in the sum for all other target lesions;no unequivocal progression of non-target disease;no new lesions. Progressive Disease (PD): >=20% rise in SLD from the smallest value on study;unequivocal progression of existing non-target lesions. Stable Disease (SD):Neither sufficient shrinkage for PR nor sufficient increase for PD.

Full Information

First Posted
January 8, 2010
Last Updated
July 1, 2016
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01045421
Brief Title
Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies
Official Title
A Phase 1 Dose Escalation Study of MLN8237, an Aurora A Kinase Inhibitor, in Adult Patients With Nonhematological Malignancies, Followed by a Phase 2 of MLN8237 in Lung, Breast, Head and Neck, or Gastroesophageal Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, multicenter study with a phase 1 dose escalation portion and a 2-stage, phase 2 portion, investigating MLN8237 (alisertib) in patients with advanced nonhematological malignancies.
Detailed Description
Following the determination of the Recommended Phase 2 Dose (RP2D) and schedule (Phase 1), 20 response-evaluable patients in each of the 5 tumor indications will be enrolled (Phase 2-Stage 1). An interim analysis will determine which tumor indications will proceed to enroll an additional 25 patients (Phase 2-Stage 2) to further evaluate Overall Response Rate (ORR) and other secondary endpoints.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Nonhematological Malignancies, Non-Small Cell Lung Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Head and Neck Squamous Cell Carcinoma, Gastroesophageal Adenocarcinoma
Keywords
NSCLC, SCLC, HNSCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MLN8237 (Alisertib)
Arm Type
Experimental
Arm Description
MLN8237 administered as an enteric-coated tablet (ECT)
Intervention Type
Drug
Intervention Name(s)
MLN8237 (Alisertib)
Intervention Description
Phase 1: MLN8237 will be administered orally twice a day on a 7-day dosing schedule Phase 2: MLN8237 will be administered orally at the maximum tolerated dose determined in Phase 1 for 7-days followed by a minimum 14-day rest period.
Primary Outcome Measure Information:
Title
Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
Description
Toxicity according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. DLT defined as any of the following considered related to alisertib by investigator: Grade 4 neutropenia (absolute neutrophil count <500 cells/cubic meter [cells/mm^3]) for >7 days; Grade 4 neutropenia with coincident fever; Grade 4 thrombocytopenia (platelets <25,000 cells/mm3) for >7 days; Platelet count <10,000 cells/mm3; Grade 3 thrombocytopenia with clinically significant bleeding; Delay in initiation of the subsequent therapy cycle by >7 days due to treatment-related toxicity; >=Grade 3 nonhematological toxicity except >=Grade 3 nausea/emesis occurred in the absence of optimal antiemetic therapy; >=Grade 3 diarrhea occurred in the absence of optimal supportive therapy with loperamide/comparable antidiarrheal; Grade 3 fatigue for <1 week; Other Grade 3 nonhematological toxicity that could be safely, reliably controlled to <=Grade 2 with appropriate treatment.
Time Frame
Phase 1: Cycle 1 Day 1 to Cycle 2 Day 21
Title
Phase 2: Percentage of Participants With Objective Response
Description
Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<] 10 millimeter [mm]). No new lesions. PR was defined as greater than or equal to (>=) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time Frame
Baseline until complete response or partial response, assessed every 2 cycles up to end of study (up to 50 cycles)
Secondary Outcome Measure Information:
Title
Phase 2: Progression-free Survival (PFS)
Description
PFS was defined as the time from randomization (or the first dose of study treatment for non-randomized studies) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this included the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.
Time Frame
Baseline until progressive disease, assessed every 2 cycles up to end of study (up to 50 cycles)
Title
Phase 2: Time to Disease Progression (TTP)
Description
Time in days from start of study treatment to first documentation of objective tumor progression. Tumor progression as per RECIST 1.1 was defined as at least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1or more new lesions is also considered progression.
Time Frame
Baseline until disease progression, assessed every 2 cycles up to end of study (up to 50 cycles)
Title
Phase 2: Duration of Response (DOR)
Description
Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response=(the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1). CR: complete disappearance of all target lesions and non-target disease, except nodal disease; all nodes decreased to normal; no new lesions. PR: >=30% decrease under baseline of the sum of diameters of all target lesions; no unequivocal progression of non-target disease; no new lesions. Tumor progression: >=20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study); absolute increase of >=5 mm; appearance of >=1 new lesions is also considered progression. DOR calculated for the subgroup of participants with objective response.
Time Frame
Baseline up to Week 50
Title
Phase 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events and Serious Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event.
Time Frame
Baseline up to 30 days after the last dose of study drug
Title
Phase 1: Cmax- Maximum Observed Plasma Concentration for Alisertib
Description
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame
Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours post-dose
Title
Phase 1: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib
Description
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.
Time Frame
Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose
Title
Phase 1: AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for Alisertib
Description
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Time Frame
Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose
Title
Phase 1: Terminal Phase Elimination Half-life (T1/2) for Alisertib
Description
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time Frame
Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose
Title
Phase 1: Rac- Accumulation Ratio for Alisertib
Description
Rac was estimated as a ratio of AUC (0-tau) at Day 7 and AUC (0-tau) at Day 1. Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Time Frame
Days 1 and 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose
Title
Phase 1: Peak to Trough Ratio for Alisertib
Description
Peak to trough ratio was estimated as a ratio of Cmax at Day 7 and the minimum observed plasma concentration (Ctrough) of alisertib at Day 7. Cmax is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. Ctrough is the minimum plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame
Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose
Title
Phase 1: Steady State Oral Clearance (CLss/F) for Alisertib
Description
CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-tau), expressed in liter per hour (L/hr).
Time Frame
Day 7: predose, 30 minutes, 1, 2, 3, 4, 6, 8, and 12 hours postdose
Title
Phase 2: Relationship Between Clinical Response and Molecular Markers of Response
Description
In SCLC,chemo-sensitive/resistant population were analyzed;in breast cancers,ER2 and ER2 status were analyzed.HR+ =estrogen receptor-positive or progesterone receptor-positive. HER+ =human epidermal growth factor receptor 2 (HER2). Triple negative =negative for estrogen receptors, progesterone receptors, and HER2.Clinical response according to RECIST version 1.1. CR:complete disappearance of all target lesions,non-target disease,except nodal disease;all nodes decrease to normal (short axis <10 mm);no new lesions. PR:>=30% decrease under baseline of the sum of diameters of all target lesions (SLD);short axis was used in the sum for target nodes,longest diameter used in the sum for all other target lesions;no unequivocal progression of non-target disease;no new lesions. Progressive Disease (PD): >=20% rise in SLD from the smallest value on study;unequivocal progression of existing non-target lesions. Stable Disease (SD):Neither sufficient shrinkage for PR nor sufficient increase for PD.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in the study: 18 years or older Histologically or cytologically confirmed metastatic and/or advanced solid tumor (Phase 1 only) Phase 2 requires Non-small cell lung cancer (NSCLC); Small-cell lung cancer; Breast adenocarcinoma (female patients only); Squamous cell cancer of the head and neck (HNSCC); or Gastroesophageal adenocarcinoma Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or abstain from heterosexual intercourse Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse Voluntary written consent Wiling to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures Measurable disease (Phase 2 only) Exclusion Criteria: Patients meeting any of the following exclusion criteria are not to be enrolled in the study: Female patients who are pregnant or lactating Serious medical or psychiatric illness that could interfere with protocol completion Receipt of more than 2 previous cytotoxic chemotherapeutic regimens (4 previous regimens for breast cancer). There is no limit on the number of prior noncytotoxic therapies Prior treatment with Aurora A-targeted agents, including MLN8237 Prior treatment with high-dose chemotherapy Prior allogeneic bone marrow or other organ transplant Antineoplastic therapy, radiation therapy or any experimental therapy 21 days prior to first dose of MLN8237 Symptomatic brain metastasis Radiotherapy to greater than 25% of bone marrow Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected Myocardial infarction within 6 months of enrollment Uncontrolled cardiovascular condition Major surgery within 14 days of first dose of MLN8237 Active infection requiring systemic therapy, or other serious infection Inability to swallow oral medication Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C Patients requiring full systemic anticoagulation History of uncontrolled sleep apnea syndrome Treatment with clinically significant enzyme inducers within 14 days prior to the first dose of MLN8237 and during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Millennium Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
City
Houston
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25728526
Citation
Melichar B, Adenis A, Lockhart AC, Bennouna J, Dees EC, Kayaleh O, Obermannova R, DeMichele A, Zatloukal P, Zhang B, Ullmann CD, Schusterbauer C. Safety and activity of alisertib, an investigational aurora kinase A inhibitor, in patients with breast cancer, small-cell lung cancer, non-small-cell lung cancer, head and neck squamous-cell carcinoma, and gastro-oesophageal adenocarcinoma: a five-arm phase 2 study. Lancet Oncol. 2015 Apr;16(4):395-405. doi: 10.1016/S1470-2045(15)70051-3. Epub 2015 Feb 27.
Results Reference
derived
PubMed Identifier
24879333
Citation
Falchook G, Kurzrock R, Gouw L, Hong D, McGregor KA, Zhou X, Shi H, Fingert H, Sharma S. Investigational Aurora A kinase inhibitor alisertib (MLN8237) as an enteric-coated tablet formulation in non-hematologic malignancies: phase 1 dose-escalation study. Invest New Drugs. 2014 Dec;32(6):1181-7. doi: 10.1007/s10637-014-0121-6. Epub 2014 Jun 1.
Results Reference
derived

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Alisertib in Adults With Nonhematological Malignancies, Followed by Alisertib in Lung, Breast, Head and Neck or Gastroesophageal Malignancies

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