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

Neoplasms Clinical Trial

Official title:

A Phase I Dose Escalation Study of MK1496 in Patients With Advanced Solid Tumor

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

• Malignant
• Neoplasms

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