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


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Cancer

Thank you

Trial Information

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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

From randomization up to 30 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MK-8669-007

NCT ID:

NCT00739830

Start Date:

August 2008

Completion Date:

July 2012

Related Keywords:

  • Endometrial Cancer
  • Carcinoma
  • Endometrial Neoplasms
  • Adenoma

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