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

Phase 1

Completed

• Conditions: Malignant; Neoplasms
• Interventions: Drug: MK-1496

• Registration Number: NCT00880568
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-13
• Study First Posted: 2009-04-14
• Primary Completion: 2010-11
• Study Completion: 2011-01
• Results First Submitted: 2012-09-25
• Results First Submitted QC: 2012-10-25
• Results First Posted: 2012-10-26
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MK-1496 80 mg (21-Day Cycle)	MK-1496	Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
MK-1496 40 mg (28-Day Cycle)	MK-1496	Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 80 mg (28-Day Cycle)	MK-1496	Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 20 mg (28-Day Cycle)	MK-1496	Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 20 mg (21-Day Cycle)	MK-1496	Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
MK-1496 40 mg (21-Day Cycle)	MK-1496	Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
MK-1496 120 mg (21-Day Cycle)	MK-1496	Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
MK-1496 100 mg (28-Day Cycle)	MK-1496	Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
MK-1496 120 mg (28-Day Cycle)	MK-1496	Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle

Primary Outcome Measures

Name	Time	Method
Number of Participants With Any Clinical or Laboratory Adverse Event	First dose up to 30 days after last dose (up to 2 years)	This is a measure of the number of participants who experienced any adverse event (AE) while on study.
Number of Participants With Dose-limiting Toxicities (DLTs)	Cycle 1 (up to 21 or 28 days, depending on treatment arm)	Dose-limiting toxicities (DLTs) are any adverse events that are not clearly related to disease progression including Grade 4 neutropenia, Grade 3 or 4 febrile neutropenia, thrombocytopenic bleeding or Grade 4 thrombocytopenia, and any Grade 3 or 4 non hematologic toxicity. An adverse event (AE) is any unfavorable and unintended change in the structure and function (Clinical AE) or chemistry (Laboratory AE) of the body temporally associated with the use of study product, whether or not considered related to the use of the product.

Secondary Outcome Measures

Name	Time	Method
Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)	Cycle 1, Day 3 (Hour 0 through Hour 24)	AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 3 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.; AUC\[0-24\] for the Day 1 doses is reported as Outcome Measure 4.
Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)	Cycle 1, Day 1 (Hour 0 through Hour 24)	AUC\[0-24\] is a measure of the total plasma exposure of drug over a 24-hour period after the initial dose; for this analysis AUC was measured on Day 1 of the first 21-day cycle.; AUC\[0-24\] for the 28-day cycle is reported as Outcome Measures 4 and 5.
Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)	Cycle 1, Day 1 (Hour 0 through Hour 24)	AUC is a measure of the total plasma exposure of a drug. For this analysis, AUC was measured just prior to dosing and through 24 hours postdose on Day 1 of Weeks 1, 2, and 3 in Cycle 1. The AUC value presented is the mean AUC for all measurements.; AUC\[0-24\] for the Day 3 doses is reported as Outcome Measure 5.