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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00880568
Other study ID # 1496-002
Secondary ID 2009_575
Status Completed
Phase Phase 1
First received April 10, 2009
Last updated February 2, 2015
Start date April 2009
Est. completion date January 2011

Study information

Verified date February 2015
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date January 2011
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Dose-limiting Toxicities (DLTs) 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. Cycle 1 (up to 21 or 28 days, depending on treatment arm) Yes
Primary Number of Participants With Any Clinical or Laboratory Adverse Event This is a measure of the number of participants who experienced any adverse event (AE) while on study. First dose up to 30 days after last dose (up to 2 years) Yes
Secondary Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle) 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.
Cycle 1, Day 1 (Hour 0 through Hour 24) No
Secondary Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle) 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.
Cycle 1, Day 1 (Hour 0 through Hour 24) No
Secondary Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle) 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.
Cycle 1, Day 3 (Hour 0 through Hour 24) No
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