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| ID | Type | Description | Link |
|---|---|---|---|
| AP23573-07-302 |
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| Name | Class |
|---|---|
| Ariad Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine whether maintenance therapy with oral AP23573 (ridaforolimus), by preventing and controlling tumor growth for a prolonged period of time in patients with metastatic soft-tissue or bone sarcomas responding to chemotherapy, will result in clinically significant improvement in progression-free survival as compared to oral placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridaforolimus | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ridaforolimus | Drug | Four 10 mg tablets taken by mouth for 5 days per week continuously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Up to 157 weeks after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival: First Analysis | Up to 157 weeks after randomization | |
| Best Target Lesion Response (RECIST) | Up to 157 weeks after randomization | |
| Overall Survival: Updated Analysis as of 30 April 2011 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23715582 | Result | Demetri GD, Chawla SP, Ray-Coquard I, Le Cesne A, Staddon AP, Milhem MM, Penel N, Riedel RF, Bui-Nguyen B, Cranmer LD, Reichardt P, Bompas E, Alcindor T, Rushing D, Song Y, Lee RM, Ebbinghaus S, Eid JE, Loewy JW, Haluska FG, Dodion PF, Blay JY. Results of an international randomized phase III trial of the mammalian target of rapamycin inhibitor ridaforolimus versus placebo to control metastatic sarcomas in patients after benefit from prior chemotherapy. J Clin Oncol. 2013 Jul 1;31(19):2485-92. doi: 10.1200/JCO.2012.45.5766. Epub 2013 May 28. |
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| Placebo | Drug | Four 10 mg tablets taken by mouth for 5 days per week continuously |
|
| Up to 184 weeks after randomization |
| Overall Survival: Updated Analysis as of 21 January 2012 | Up to 222 weeks after randomization |
| Safety and tolerability | Up to 157 weeks after randomization |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| C515074 | ridaforolimus |
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