Skip to main content
OpenTrials
Completed

NCT Number: NCT00880568

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms Malignant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MK-1496

Drug

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

Primary outcomes

  1. Number of Participants With Dose-limiting Toxicities (DLTs)

    Time frame: 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.

  2. Number of Participants With Any Clinical or Laboratory Adverse Event

    Time frame: 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.

Secondary outcomes

  1. Area Under the Curve From Hour 0 to Hour 24 (AUC[0-24]) for MK-1496 Single Dose (21-Day Cycle)

    Time frame: 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.

  2. Mean AUC[0-24] of MK-1496 on Day 1 of Multiple Dose Administration (28-Day Cycle)

    Time frame: 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.

  3. Mean AUC[0-24] of MK-1496 on Day 3 of Multiple Dose Administration (28-Day Cycle)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Apr 14, 2009
Registry last updated
Feb 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.