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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_011 | Other Identifier | Study Number |
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A clinical study evaluates the safety, tolerability, and pharmacokinetics of ridaforolimus (MK-8669) in participants with locally advanced or metastatic solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridaforolimus | Experimental | Ridaforolimus (MK-8669), 20 or 40 mg administered orally on Day 1 followed by a washout of at least 6 days, then QD x5 (five consecutive days) followed by a 2-day holiday through Day 28 (Cycle 1), and QD x5 followed by a 2-day holiday for 21 days (Cycle 2 and subsequent cycles). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ridaforolimus | Drug | Ridaforolimus (MK-8669), 20 or 40 mg administered orally on Day 1 followed by a washout of at least 6 days, then QD x5 (five consecutive days) followed by a 2-day holiday through Day 28 (Cycle 1), and QD x5 followed by a 2-day holiday for 21 days (Cycle 2 and subsequent cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ridaforolimus Dose Limiting Toxicities | Cycle 1 (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 1 (Single Dose, 20 mg or 40 mg) | Day 1 | |
| Area Under the Plasma Concentration-Time Curve (AUC) for Ridaforolimus for Day 26 (Multiple Doses, 20 mg or 40 mg) | Day 26 |
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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 |
|---|---|---|---|
| 22143378 | Result | Seki Y, Yamamoto N, Tamura Y, Goto Y, Shibata T, Tanioka M, Asahina H, Nokihara H, Yamada Y, Shimamoto T, Noguchi K, Tamura T. Phase I study for ridaforolimus, an oral mTOR inhibitor, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2012 Apr;69(4):1099-105. doi: 10.1007/s00280-011-1788-4. Epub 2011 Dec 6. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
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| C515074 | ridaforolimus |
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| Maximum Plasma Concentration (Cmax) for Day 1 (Single Dose of Ridaforolimus, 20 mg or 40 mg) | Day 1 |
| Maximum Plasma Concentration (Cmax) for Day 26 (Multiple Doses of Ridaforolimus, 20 mg and 40 mg) | Day 26 |