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

NCT ID: NCT00739830

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2012-07-31

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus

Group Type: EXPERIMENTAL

ridaforolimus

Intervention Type: DRUG

40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus

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

Group Type: ACTIVE_COMPARATOR

medroxyprogesterone acetate tablets OR megestrol acetate

Intervention Type: DRUG

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

chemotherapy

Intervention Type: 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

Interventions

ridaforolimus

40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus

Intervention Type: 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)

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

deforolimus, AP23573, MK-8669; ridaforolimus was also known as deforolimus until May 2009

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: BACKGROUND

PMID: 26077241 (View on PubMed)

Other Identifiers

AP23573-07-205

Identifier Type: OTHER

Identifier Source: secondary_id

8669-007

Identifier Type: -

Identifier Source: org_study_id