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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00730379
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : February 10, 2015
Ariad Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment Phase
Neoplasms Drug: Comparator: ridaforolimus + dalotuzumab Phase 1

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer
Study Start Date : July 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
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).

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00730379

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

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00730379     History of Changes
Other Study ID Numbers: 8669-004
First Posted: August 8, 2008    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Antibodies, Monoclonal
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs