A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma
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)