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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neoplasms Malignant

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-1496 20 mg (21-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle

MK-1496 40 mg (21-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle

MK-1496 80 mg (21-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle

MK-1496 120 mg (21-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle

MK-1496 20 mg (28-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

MK-1496 40 mg (28-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

MK-1496 80 mg (28-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

MK-1496 100 mg (28-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

MK-1496 120 mg (28-Day Cycle)

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

Group Type EXPERIMENTAL

MK-1496

Intervention Type DRUG

MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

Interventions

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MK-1496

MK-1496 (20 to 120 mg), orally, administered on Day 1 of each 21-day cycle

Intervention Type DRUG

MK-1496

MK-1496 (20 to 120 mg), orally, administered on Days 1 and 3 each week for 3 weeks (Days 1, 3, 8, 10, 15 and 17) of each 28-day cycle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No