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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01110603

Enrollment

Registered

2010-04-26

Start date

2010-07-31

Completion date

2011-07-31

Last updated

2016-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer: Solid Tumors

Keywords

Cancer, Advanced Solid Tumors

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.

Detailed description

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

Interventions

DRUGpaclitaxel

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

DRUGMK-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.

DRUGcarboplatin

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

DRUGliposomal doxorubicin

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with dose limiting toxicities (DLTs)	Each cycle (21 or 28 Days)

Secondary

Measure	Time frame
Number of participants with clinical and laboratory adverse events (AEs)	Baseline to 30 days post last dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026