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Completed

NCT Number: NCT00739830

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

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.

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Key information

Conditions

Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ridaforolimus

Drug

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

medroxyprogesterone acetate tablets OR megestrol acetate

Drug

oral medroxyprogesterone acetate tablets 200 mg daily OR oral megestrol acetate tablets 40 mg 4 times per day (160 mg daily)

Chemotherapy

Drug

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

Primary outcomes

  1. Progression-free survival (PFS)

    Time frame: From randomization up to 30 months

Secondary outcomes

  1. The proportion of patients progression free at 16 weeks as assessed using modified RECIST guidelines.

    Time frame: From randomization to Week 16

  2. The proportion of patients progression free at 26 weeks as assessed using modified RECIST guidelines

    Time frame: From randomization to Week 26

  3. Overall survival

    Time frame: From randomization up to 30 months

  4. 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

  5. Safety and tolerability

    Time frame: From randomization up to 30 days after discontinuation of treatment

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Aug 22, 2008
Registry last updated
Jul 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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