Clinical trial NCT00739830: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometrial Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: From randomization up to 30 months
Secondary outcomes:
measure: The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.
timeFrame: From randomization to Week 16
measure: The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines
timeFrame: From randomization to Week 26
measure: Overall survival
timeFrame: From randomization up to 30 months
measure: Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression
timeFrame: From randomization up to 30 months
measure: Safety and tolerability
timeFrame: From randomization up to 30 days after discontinuation of treatment
Other outcomes:
Locations:
Study officials:
References:
citation: Oza AM, Pignata S, Poveda A, McCormack M, Clamp A, Schwartz B, Cheng J, Li X, Campbell K, Dodion P, Haluska FG. Randomized Phase II Trial of Ridaforolimus in Advanced Endometrial Carcinoma. J Clin Oncol. 2015 Nov 1;33(31):3576-82. doi: 10.1200/JCO.2014.58.8871. Epub 2015 Jun 15.