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

NCT00739830 | Completed Phase 2

• 2 other identifiers: 8669-007AP23573-07-205
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  From randomization up to 30 months

Secondary Outcomes (5)

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

  From randomization to Week 16

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

  From randomization to Week 26

• Overall survival

  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

  From randomization up to 30 months

• Safety and tolerability

  From randomization up to 30 days after discontinuation of treatment

Study Arms (2)

1

EXPERIMENTAL

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

Drug: ridaforolimus

2

ACTIVE COMPARATOR

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; Drug: chemotherapy

Interventions

ridaforolimus DRUG

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

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

1

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)

2

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 26077241 BACKGROUND

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

ridaforolimus; Medroxyprogesterone Acetate; Megestrol Acetate; Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Megestrol; Pregnadienes; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2008
• First Posted: August 22, 2008
• Study Start: August 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 1, 2015

Record last verified: 2015-06