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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: ridaforolimus 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: ridaforolimus
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 |
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: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00739830 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Medroxyprogesterone 17-Acetate Antineoplastic Agents, Hormonal Contraceptive Agents Hormone Antagonists Contraceptives, Oral Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Genital Neoplasms, Female Uterine Diseases Central Nervous System Stimulants Urogenital Neoplasms Endometrial Cancer |
Contraceptive Agents, Male Hormones Megestrol Carcinoma Genital Diseases, Female Endometrial Neoplasms Progestins Uterine Neoplasms Medroxyprogesterone Appetite Stimulants Megestrol Acetate |
Medroxyprogesterone 17-Acetate Contraceptive Agents Antineoplastic Agents Contraceptives, Oral Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Contraceptive Agents, Female Urogenital Neoplasms Reproductive Control Agents Contraceptive Agents, Male Hormones Genital Diseases, Female Endometrial Neoplasms Neoplasms by Site Progestins |
Therapeutic Uses Uterine Neoplasms Contraceptives, Oral, Synthetic Appetite Stimulants Antineoplastic Agents, Hormonal Genital Neoplasms, Female Uterine Diseases Central Nervous System Stimulants Megestrol Pharmacologic Actions Neoplasms Medroxyprogesterone Central Nervous System Agents Megestrol Acetate |