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Clinical Trial of Deforolimus Compared to Progestin in Endometrial Carcinoma Following One Line of Chemotherapy
This study is currently recruiting participants.
Verified by Ariad Pharmaceuticals, August 2009
First Received: August 20, 2008   Last Updated: August 20, 2009   History of Changes
Sponsors and Collaborators: Ariad Pharmaceuticals
Merck
Information provided by: Ariad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00739830
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Ariad Pharmaceuticals:

Primary Outcome Measures:
  • Progression-free survival (PFS) [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]

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
1: Experimental
40 mg once daily oral tablets for 5 days followed by 2 days without deforolimus
Drug: ridaforolimus
40 mg once daily oral tablets for 5 days followed by 2 days without deforolimus
2: Active Comparator
oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Endometrial cancer
  • Patients must have been treated with one cytotoxic regimen
  • At least one measurable lesion
  • ECOG performance status less than or equal to 1
  • Minimum life expectancy of 3 months
  • Adequate renal and hepatic function
  • Adequate bone marrow function
  • Serum cholesterol <350 mg/dL and triglycerides < 400 mg/dL
  • Able to understand and give written informed consent
  • Females of childbearing potential must have a negative pregnancy test and use approved contraception from screening to 30 days after the last study drug is given

Exclusion Criteria:

  • More than one prior regimen of cytotoxic chemotherapy
  • Prior therapy with hormonal agents
  • Women who are pregnant or lactating
  • Presence of brain or other central nervous system metastases
  • Prior therapy with rapamycin, rapamycin analogues or tacrolimus or known sensitivity to these agents
  • Anticancer treatment (chemotherapy, radiotherapy) within 4 weeks prior to randomization
  • Ongoing toxicity associated with prior anticancer therapy
  • Inadequate recovery from any prior surgical procedure or having undergone any major surgical procedure within 2 weeks prior to randomization.
  • Another primary malignancy within the past five years (except for non-melanoma skin cancer and cervical carcinoma in situ)
  • Known Grade 3 or 4 hypersensitivity to macrolide antibiotics
  • Significant uncontrolled cardiovascular disease
  • Active infection
  • Known HIV infection
  • Known Hepatitis B or C infection
  • Newly diagnosed (within 3 months before enrollment) or poorly controlled Type 1 or 2 diabetes
  • Concurrent treatment with immunosuppressive agents
  • A requirement for concurrent treatment with medication that strongly induce or inhibit cytochrome P450 (CYP3A)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739830

Contacts
Contact: Frank Haluska, M.D., Ph.D. (617) 494-0400 Frank.Haluska@ariad.com

  Show 48 Study Locations
Sponsors and Collaborators
Ariad Pharmaceuticals
Merck
Investigators
Study Director: Frank Haluska, M.D., Ph.D. Ariad Pharmaceuticals
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009