A Study of MK-4827 in Combination With Standard Chemotherapy in Participants With Advanced Solid Tumors (MK-4827-008 AM1)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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The decision to discontinue new enrollment is not related to any concerns about the safety profile of the product.

Conditions

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Cancer: Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-4827 + carboplatin

Group Type EXPERIMENTAL

MK-4827

Intervention Type DRUG

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.

carboplatin

Intervention Type DRUG

Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle

MK-4827 + carboplatin/paclitaxel

Group Type EXPERIMENTAL

MK-4827

Intervention Type DRUG

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.

carboplatin

Intervention Type DRUG

Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle

paclitaxel

Intervention Type DRUG

Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle

MK-4827 + carboplatin/liposomal doxorubicin

Group Type EXPERIMENTAL

MK-4827

Intervention Type DRUG

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.

carboplatin

Intervention Type DRUG

Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle

liposomal doxorubicin

Intervention Type DRUG

Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle

Interventions

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MK-4827

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.

Intervention Type DRUG

carboplatin

Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle

Intervention Type DRUG

paclitaxel

Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle

Intervention Type DRUG

liposomal doxorubicin

Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No