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| ID | Type | Description | Link |
|---|---|---|---|
| AP23573-04-202 | Other Identifier | Ariad Pharmaceuticals, Inc. | |
| 2004-002231-92 | EudraCT Number |
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| Name | Class |
|---|---|
| Ariad Pharmaceuticals | INDUSTRY |
The purpose of this study is to assess the efficacy of ridaforolimus when administered once daily for 5 consecutive days (QDx5) every two weeks in participants with advanced sarcoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridaforolimus | Experimental | 12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ridaforolimus | Drug | 12.5 mg of ridaforolimus is given intravenously over 30 minutes once daily for 5 days, every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Clinical Benefit Response (CBR) Using Response Criteria in Solid Tumors (RECIST) | Day 1 up to 4 years or discontinuation from study |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Tumor Progression | Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) | |
| Progression Free Survival | Day 1 to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22067397 | Result | Chawla SP, Staddon AP, Baker LH, Schuetze SM, Tolcher AW, D'Amato GZ, Blay JY, Mita MM, Sankhala KK, Berk L, Rivera VM, Clackson T, Loewy JW, Haluska FG, Demetri GD. Phase II study of the mammalian target of rapamycin inhibitor ridaforolimus in patients with advanced bone and soft tissue sarcomas. J Clin Oncol. 2012 Jan 1;30(1):78-84. doi: 10.1200/JCO.2011.35.6329. Epub 2011 Nov 7. |
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| Overall Survival | Day 1 to the date of death, or the date of last contact (up to 4 years) |
| Duration of Response | Day 1 up to the first observation of disease progression, death, or the date of the last evaluation of response (up to 4 years) |
| Number of participants experiencing adverse events | From first dose up to 30 days after last dose (up to 1 year) |
| Number of participants who discontinued study drug due to adverse events | From first dose up to the last dose (up to 1 year) |
| Mean ridaforolimus blood levels within 5 minutes post intravenous infusion | Day 1 and Day 5 of Cycle 1 |
| ID | Term |
|---|---|
| D007890 | Leiomyosarcoma |
| D008080 | Liposarcoma |
| D012516 | Osteosarcoma |
| D012509 | Sarcoma |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018205 | Neoplasms, Adipose Tissue |
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C515074 | ridaforolimus |
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