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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

August 6, 2008
December 17, 2010
July 2008
November 2010   (final data collection date for primary outcome measure)
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 ]
To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. [ Time Frame: You will be evaluated for disease progression ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00730379 on ClinicalTrials.gov Archive Site
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 ]
To measure pharmacokinetic and pharmacodynamic parameters with oral deforolimus as a single agent and in combination with MK0646. [ Time Frame: CT scan or MRI, done 14 days before dosing on Day 1 & 7 days before dosing in cycles 3, 5, 7 and every 2 cycles after (1 cycle is 28 days).Skin &/or tumor biopsies are required. FDG-PET scan may be required. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Combination Study With Ridaforolimus (MK8669) and Dalotuzumab (MK0646) in Patients With Advanced Cancer (8669-004)
A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Neoplasms
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).
Experimental: 1
ridaforolimus (MK8669) + dalotuzumab (MK0646)
Intervention: Drug: Comparator: ridaforolimus + dalotuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
87
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00730379
2008_538, MK8669-004
Not Provided
Vice President of Late Stage Development, Merck Sharp & Dohme Corp
Merck Sharp & Dohme Corp.
Ariad Pharmaceuticals
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP