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
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

ClinicalTrials.gov processed this record on April 15, 2014