Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)

June 30, 2015 updated by: Merck Sharp & Dohme LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
Drug: ridaforolimus
40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
Other Names:
  • deforolimus, AP23573, MK-8669; ridaforolimus was also known as deforolimus until May 2009
Active Comparator: 2
Investigator's choice of: oral medroxyprogesterone acetate tablets 200 mg daily or oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily) OR Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator
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)
Drug: chemotherapy
Chemotherapy - carboplatin, paclitaxel, doxorubicin, pegylated liposomal doxorubicin or topotecan administered as a single agent or as a doublet, and will be administered at doses and schedules chosen by the investigator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival (PFS)
Time Frame: From randomization up to 30 months
From randomization up to 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.
Time Frame: From randomization to Week 16
From randomization to Week 16
The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines
Time Frame: From randomization to Week 26
From randomization to Week 26
Overall survival
Time Frame: From randomization up to 30 months
From randomization up to 30 months
Best target lesion response, defined as best change in sum of the target lesions from baseline to disease progression
Time Frame: From randomization up to 30 months
From randomization up to 30 months
Safety and tolerability
Time Frame: From randomization up to 30 days after discontinuation of treatment
From randomization up to 30 days after discontinuation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

August 20, 2008

First Submitted That Met QC Criteria

August 20, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

July 1, 2015

Last Update Submitted That Met QC Criteria

June 30, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8669-007
  • AP23573-07-205 (Other Identifier: ARIAD study number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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