Brief Title
Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)
Official Title
A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Progression-free survival (PFS)
Secondary Outcome
The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.
Condition
Endometrial Cancer
Intervention
ridaforolimus
Study Arms / Comparison Groups
1
Description: 40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
130
Start Date
August 2008
Completion Date
July 2012
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Endometrial cancer
- Patients must have been treated with at least one line of chemotherapy, but not more
than two lines of chemotherapy, and experienced progressive disease
- 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:
- Two lines of chemotherapy for recurrent or metastatic disease
- Chemotherapy for recurrent or metastatic disease administered within six months of
adjuvant therapy
- More than two lines of chemotherapy of any type
- 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)
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT00739830
Organization ID
8669-007
Secondary IDs
AP23573-07-205
Responsible Party
Sponsor
Study Sponsor
Merck Sharp & Dohme LLC
Study Sponsor
, ,
Verification Date
June 2015