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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_538 |
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| Name | Class |
|---|---|
| Ariad Pharmaceuticals | INDUSTRY |
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | ridaforolimus (MK8669) + dalotuzumab (MK0646) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: ridaforolimus + dalotuzumab | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the toxicity profile, maximum tolerated dose and recommended phase II dose. | MTD from Day 1 to Day 28 in Cycle 1 for disease progression |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25320355 | Result | Di 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. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C569480 | dalotuzumab |
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