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

Tesaro

Status and phase: Terminated; Phase 1

Conditions: Cancer: Solid Tumors

Treatments: Drug: carboplatin; Drug: paclitaxel; Drug: MK-4827; Drug: liposomal doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110603

MK-4827-008

2010_528

Details and patient eligibility

About

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.

Full description

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

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

MK-4827 + carboplatin

Experimental group

Treatment:

Drug: carboplatin

Drug: MK-4827

MK-4827 + carboplatin/paclitaxel

Experimental group

Treatment:

Drug: carboplatin

Drug: MK-4827

Drug: paclitaxel

MK-4827 + carboplatin/liposomal doxorubicin

Experimental group

Treatment:

Drug: carboplatin

Drug: MK-4827

Drug: liposomal doxorubicin