A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)

This study has been completed.
Sponsor:
Collaborator:
Ariad Pharmaceuticals
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00730379
First received: August 6, 2008
Last updated: December 17, 2010
Last verified: December 2010
  Purpose

This study is being done to find the best tolerated dose of ridaforolimus and dalotuzumab in patients who have advanced cancer and to observe any anti-tumor activity in these patients.


Condition Intervention Phase
Neoplasms
Drug: Comparator: ridaforolimus + dalotuzumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. [ Time Frame: MTD from Day 1 to Day 28 in Cycle 1 for disease progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab [ Time Frame: At prescribed timepoints as defined in the protocol ] [ Designated as safety issue: No ]

Enrollment: 87
Study Start Date: July 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ridaforolimus (MK8669) + dalotuzumab (MK0646)
Drug: Comparator: ridaforolimus + dalotuzumab
Starting dose of oral ridaforolimus is 10 mg/day, QD, for five days. Dose rising up to 40 mg/day, QD for five days. Dose range for intravenous dalotuzumab is 7.5 mg/kg/week, 10 mg/kg/week or 7.5 mg/kg/every 14 days. Dalotuzumab will be given as an IV infusion over 1 or 2 hour(s).

Detailed Description:

Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009

  Eligibility

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

Inclusion Criteria:

  • You must have confirmed metastatic or advanced cancer that has not responded to standard therapy or where standard therapy does not exist
  • In Part C, patients must have a diagnosis of advanced or metastatic colorectal adenocarcinoma or non-small cell lung cancer, and must have received at least 1 but no more than three prior systemic therapy treatment regimens
  • You must be over the age of 18 years old
  • You must have a ECOG status performance of 0 or 1
  • You must have good organ function
  • You must be willing to have skin and/or tumor biopsies

Exclusion Criteria:

  • You have had cancer treatment within 4 weeks prior to entering the study or you still have bad side effects from previous therapies
  • You have an active infection that requires treatment
  • You are HIV positive or have a history of Hepatitis B or C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730379

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00730379     History of Changes
Other Study ID Numbers: 2008_538, MK8669-004
Study First Received: August 6, 2008
Last Updated: December 17, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Antibodies, Monoclonal
Sirolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014