A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)
A Phase Ib Dose Escalation Study of MK-4827 in Combination With Carboplatin, Carboplatin/Paclitaxel and Carboplatin/Liposomal Doxorubicin in Patients With Advanced Solid Tumors
2 other identifiers
interventional
12
0 countries
N/A
Brief Summary
This study will find the dose limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of MK4827 when administered in combination with standard doses of carboplatin, or carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin in the treatment of advanced solid cancers in adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2010
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedMay 5, 2016
March 1, 2012
1 year
April 22, 2010
May 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with dose limiting toxicities (DLTs)
Each cycle (21 or 28 Days)
Secondary Outcomes (1)
Number of participants with clinical and laboratory adverse events (AEs)
Baseline to 30 days post last dose
Study Arms (3)
MK-4827 + carboplatin
EXPERIMENTALMK-4827 + carboplatin/paclitaxel
EXPERIMENTALMK-4827 + carboplatin/liposomal doxorubicin
EXPERIMENTALInterventions
Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.
Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle
Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle
Eligibility Criteria
You may qualify if:
- Participant has a locally advanced or metastatic solid tumor for which carboplatin, carboplatin/paclitaxel, or carboplatin/liposomal doxorubicin are the standard of care.
- Participant has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
You may not qualify if:
- Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks prior to entering the study.
- Participant has had more than two prior lines of chemotherapy.
- Participant has known central nervous system metastases or a primary central nervous system tumor.
- Participant is pregnant or breastfeeding or expecting to conceive during the timeframe of the study.
- Participant is known to be human immunodeficiency virus (HIV) positive.
- Participant has a history of Hepatitis B or C.
- Participant has a symptomatic pleural effusion.
- Participant with a left ventricular ejection fraction (LVEF) below the institutional norm, or with prior exposure to doxorubicin is not eligible for the MK4827 + carboplatin/liposomal doxorubicin study arm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tesaro, Inc.lead
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2010
First Posted
April 26, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
May 5, 2016
Record last verified: 2012-03