Clinical trial · Interventional
Clinical Trial of Ridaforolimus Compared to Progestin or Chemotherapy for Advanced Endometrial Carcinoma (MK-8669-007 AM6)
A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy | Drug | Chemotherapy | ALIAS |
| medroxyprogesterone acetate tablets OR megestrol acetate | Drug | — | UNRESOLVED |
| ridaforolimus | Drug | Ridaforolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- 40 mg once daily oral tablets for 5 days followed by 2 days without ridaforolimus
- interventionNames
- Drug: ridaforolimus
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- 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
- interventionNames
- Drug: medroxyprogesterone acetate tablets OR megestrol acetate
- Drug: chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- BACKGROUNDOza 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