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| ID | Type | Description | Link |
|---|---|---|---|
| AP23573-07-205 | Other Identifier | ARIAD study number |
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The purpose of this study is to compare progression-free survival (PFS) of patients with advanced, recurrent or metastatic endometrial cancer who have received one, but not more than two, prior lines of chemotherapy either as adjuvant therapy or treatment for advanced disease, and then when treated with ridaforolimus or the investigators' choice of progestin or chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus |
|
| 2 | Active Comparator | Investigator's choice of: oral medroxyprogesterone acetate tablets 200 mg daily or oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily) OR Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ridaforolimus | Drug | 40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | From randomization up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines. | From randomization to Week 16 | |
| The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines | From randomization to Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26077241 | Background | Oza AM, Pignata S, Poveda A, McCormack M, Clamp A, Schwartz B, Cheng J, Li X, Campbell K, Dodion P, Haluska FG. Randomized Phase II Trial of Ridaforolimus in Advanced Endometrial Carcinoma. J Clin Oncol. 2015 Nov 1;33(31):3576-82. doi: 10.1200/JCO.2014.58.8871. Epub 2015 Jun 15. |
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| medroxyprogesterone acetate tablets OR megestrol acetate | Drug | oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily) |
|
| chemotherapy | Drug | Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator |
|
| Overall survival | From randomization up to 30 months |
| Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression | From randomization up to 30 months |
| Safety and tolerability | From randomization up to 30 days after discontinuation of treatment |
| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C515074 | ridaforolimus |
| D017258 | Medroxyprogesterone Acetate |
| D019290 | Megestrol Acetate |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D013812 | Therapeutics |
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