NCT00730379CompletedPhase 1
A Phase I Study of Ridaforolimus (MK8669) and MK0646 in Patients With Advanced Cancer
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 87
- Primary Endpoint
- To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
Study Overview
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.
Detailed Description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
1
Experimental
ridaforolimus (MK8669) + dalotuzumab (MK0646)
Intervention: Comparator: ridaforolimus + dalotuzumab (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab(At prescribed timepoints as defined in the protocol)
Investigators
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