Phase I Study of MK-1496 in Patients With Advanced Solid Tumor (MK-1496-002 AM 4)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Neoplasms; Malignant

Treatments: Drug: MK-1496

Study type: Interventional

Funder types: Industry

Identifiers

NCT00880568

2009_575

1496-002

Details and patient eligibility

About

This study determines recommended clinical dose, to evaluate the safety, tolerability and pharmacokinetics of MK-1496 in patients with locally advanced and/or metastatic solid tumors who have failed standard therapy or for whom no standard therapy exists, in two dosing schedules in Japan.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Participant must have a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist.
• Participant must have Performance Status 0 or 1.
• Participant must have adequate organ function.

Exclusion Criteria

• Participant has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to registration.
• Participant has received 4 or greater regimens of chemotherapy (adjuvant therapy and incomplete 1 cycle treatment are not considered as 1 regimen).
• Participant has known hypersensitivity to the components of study drug or its analogs.
• Participant has had prescription or non-prescription drugs or other products known to be moderate or potent inhibitors/inducers of cytochrome P (CYP)3A4, or substrates of CYP3A4 with narrow therapeutic window.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 9 patient groups

MK-1496 20 mg (21-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle

Treatment:

Drug: MK-1496

MK-1496 40 mg (21-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle

Treatment:

Drug: MK-1496

MK-1496 80 mg (21-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle

Treatment:

Drug: MK-1496

MK-1496 120 mg (21-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle

Treatment:

Drug: MK-1496

MK-1496 20 mg (28-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Treatment:

Drug: MK-1496

MK-1496 40 mg (28-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Treatment:

Drug: MK-1496

MK-1496 80 mg (28-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Treatment:

Drug: MK-1496

MK-1496 100 mg (28-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Treatment:

Drug: MK-1496

MK-1496 120 mg (28-Day Cycle)

Experimental group

Description:

Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Treatment:

Drug: MK-1496