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

NCT00880568 | Completed Phase 1 Results

• 2 other identifiers: 1496-0022009_575
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neoplasms; Malignant

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (3)

• 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)

• 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)

• 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)

Study Arms (9)

MK-1496 20 mg (21-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 40 mg (21-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 80 mg (21-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 120 mg (21-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 20 mg (28-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 40 mg (28-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 80 mg (28-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 100 mg (28-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

MK-1496 120 mg (28-Day Cycle)

EXPERIMENTAL

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

Drug: MK-1496

Interventions

MK-1496 DRUG

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

MK-1496 120 mg (21-Day Cycle); MK-1496 20 mg (21-Day Cycle); MK-1496 40 mg (21-Day Cycle); MK-1496 80 mg (21-Day Cycle)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Vice President, Late Stage Development Group Leader
• Organization: Merck Sharp & Dohme

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2009
• First Posted: April 14, 2009
• Study Start: April 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: February 19, 2015
• Results First Posted: October 26, 2012

Record last verified: 2015-02