Clinical trial · Interventional
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
NCT00730379CI-TRIAL-00016824completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: ridaforolimus + dalotuzumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- ridaforolimus (MK8669) + dalotuzumab (MK0646)
- interventionNames
- Drug: Comparator: ridaforolimus + dalotuzumab
Primary outcomes (1)
- measure
- To determine the toxicity profile, maximum tolerated dose and recommended phase II dose.
- timeFrame
- MTD from Day 1 to Day 28 in Cycle 1 for disease progression
Secondary outcomes (1)
- measure
- To measure pharmacokinetic and pharmacodynamic parameters with oral ridaforolimus as a single agent and in combination with dalotuzumab
- timeFrame
- At prescribed timepoints as defined in the protocol
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTDi Cosimo S, Sathyanarayanan S, Bendell JC, Cervantes A, Stein MN, Brana I, Roda D, Haines BB, Zhang T, Winter CG, Jha S, Xu Y, Frazier J, Klinghoffer RA, Leighton-Swayze A, Song Y, Ebbinghaus S, Baselga J. Combination of the mTOR inhibitor ridaforolimus and the anti-IGF1R monoclonal antibody dalotuzumab: preclinical characterization and phase I clinical trial. Clin Cancer Res. 2015 Jan 1;21(1):49-59. doi: 10.1158/1078-0432.CCR-14-0940. Epub 2014 Oct 15. PMID 25320355