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Sponsors and Collaborators: |
Ariad Pharmaceuticals Merck |
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Information provided by: | Ariad Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00739830 |
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 prior chemotherapy regimen for advanced disease when treated with deforolimus or progestin
Condition | Intervention | Phase |
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Endometrial Cancer |
Drug: deforolimus Drug: medroxyprogesterone acetate tablets OR megestrol acetate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Single Group Assignment |
Official Title: | A Randomized Phase II Trial of Deforolimus (AP23573; MK-8669) Compared to Progestin in Female Adult Patients With Advanced Endometrial Carcinoma Following One Line of Chemotherapy |
Estimated Enrollment: | 150 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
40 mg once daily oral tablets for 5 days followed by 2 days without deforolimus
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Drug: deforolimus
40 mg once daily oral tablets for 5 days followed by 2 days without deforolimus
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2: Active Comparator
oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)
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Drug: medroxyprogesterone acetate tablets OR megestrol acetate
oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Frank Haluska, M.D., Ph.D. | (617) 494-0400 | Frank.Haluska@ariad.com |
United States, Louisiana | |
ARIAD Investigational Site #035 | Recruiting |
Metairie, Louisiana, United States, 70006 | |
United States, New York | |
ARIAD Investigational Site #108 | Recruiting |
Bridgewater, New York, United States, 11718 |
Study Director: | Frank Haluska, M.D., Ph.D. | Ariad Pharmaceuticals |
Responsible Party: | ARIAD Pharmaceuticals, Inc. ( Frank Haluska, MD, PhD, Vice PresidentVice President, Clinical Research ) |
Study ID Numbers: | AP23573-07-205 |
Study First Received: | August 20, 2008 |
Last Updated: | November 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00739830 |
Health Authority: | United States: Food and Drug Administration |
Genital Diseases, Female Medroxyprogesterone 17-Acetate Endometrial Neoplasms Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms |
Medroxyprogesterone Urogenital Neoplasms Endometrial cancer Megestrol Megestrol Acetate Carcinoma |
Antineoplastic Agents, Hormonal Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Contraceptive Agents, Female Central Nervous System Stimulants Reproductive Control Agents |
Contraceptive Agents, Male Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Contraceptives, Oral, Synthetic Central Nervous System Agents Appetite Stimulants |