Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001 AM4)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00543387
First received: October 12, 2007
Last updated: April 26, 2011
Last verified: April 2011
  Purpose

This study will investigate the safety, side effects and how well the body tolerates MK-5108 as well as determine different doses of MK-5108 in participants with advanced and/or refractory solid tumors.


Condition Intervention Phase
Cancer, Neoplasms, Tumors
Drug: MK-5108
Drug: docetaxel
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Investigation of MK-5108 and MK-5108 With Docetaxel in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants who experience an adverse event [ Time Frame: From Day 1 of study treatment until 30 days following the last dose of study treatment ] [ Designated as safety issue: Yes ]
  • Number of participants with dose limiting toxicities (DLTs) [ Time Frame: Day 1 to Day 21 of study treatment (Cycle 1) ] [ Designated as safety issue: Yes ]

Enrollment: 37
Study Start Date: March 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MK-5108
Participants entered into the MK-5108 group (Panel 1) will receive MK-5108 as monotherapy; MK-5108 will be administered to cohorts of participants in sequentially rising doses. MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1.
Drug: MK-5108
MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.
Experimental: MK-5108 + Docetaxel
The MK-5108 + Docetaxel group (Panel 2) will receive MK-5108 in combination with an intravenous (I.V.) dose of docetaxel (60 mg/m^2). MK-5108 will be administered to cohorts of participants in sequentially rising doses. MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 21 days in Panel 2.
Drug: MK-5108
MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.
Drug: docetaxel
intravenous (I.V.) dose of docetaxel (60 mg/m^2)
Other Name: Taxotere

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Participant has a histologically-confirmed metastatic or locally advanced solid tumor that has failed to respond to standard therapy or progressed with standard therapy

Exclusion Criteria:

  • Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks prior to study start or has not recovered from adverse events caused by therapy more than 4 weeks earlier
  • Participant is currently participating or has participated in a study with an investigational compound or device within 4 weeks prior to signing informed consent
  • Participant has received more than 2 courses of chemotherapy for metastatic disease
  • Participant has had prolonged neutropenia or neutropenia with fever from previous chemotherapy treatment
  • Participant has a primary central nervous system tumor
  • Participant is a regular or recreational user of any illicit drugs or has a recent history within the last year of drug or alcohol abuse
  • Participant is pregnant, breastfeeding or planning to have children during the study
  • Participant is Human Immunodeficiency Virus (HIV) positive
  • Participant has a history of Hepatitis B or C
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00543387     History of Changes
Other Study ID Numbers: MK-5108-001, 2007_598
Study First Received: October 12, 2007
Last Updated: April 26, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014