Clinical trial · Interventional
Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
NCT03617679CI-TRIAL-00106335completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study seeks to determine the effectiveness of Rucaparib as maintenance therapy for metastatic and recurrent endometrial cancer, after 1-2 prior lines of therapy.
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 |
|---|---|---|---|
| Metastatic Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
| Rucaparib | Drug | Rucaparib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active Ingredient
- description
- 1:1 Randomization. Participants in this arm receive the active ingredient medication.
- interventionNames
- Drug: Rucaparib
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Up to 48 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Provision to sign and date the consent form. 2. Stated willingness to comply with all study procedures and be available for the duration of the study. 3. Be a female aged 18-89. 4. Patients with a primary Stage III/IV or recurrent endometrial cancer. 5. Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy). 6. Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles. 7. Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy. 8. Patients who receive radiation to the whole pelvis or at least 50% of the spine must complete radiation therapy and have at least 4 weeks' time elapse prior to initiation of drug. 9. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 10. Absolute neutrophil count (ANC) \> or = 1500 cells/microliters 11. Platelet count \> 100,000 microliters 12. Hemoglobin \> or = 9.0 g/dL 13. Serum albumin \> or = 2.5 g/dL 14. Total bilirubin ≤ 1.5 x ULN (uppler limit of normal) 15. AST and ALT ≤ 3.0 x ULN 16. Serum Creatinine ≤ 1.5x ULN Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Inability to comply with study and follow-up procedures 2. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina 3. Known clinically significant liver disease defined as AST and ALT \> 3.0 x ULN and/or Total bilirubin \> or = 1.5 x ULN, or documented history of active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease 4. Participation in investigational clinical trial within last 30 days 5. History of significant chronic disease including HIV/AIDS or hepatitis C 6. Inability to provide informed consent 7. Known central nervous system (CNS) malignancy or CNS metastases 8. Patients with previous malignancy, other than endometrial, within the past 2 years from cycle 1, day 1, with the exception of those with negligible risk of metastasis or death, such as adequately controlled basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the breast. 9. History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1) 10. Women with prognosis for survival less than 6 months 11. Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen 12. Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion 13. Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication 14. Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing 15. Minor surgical procedure \< or = 14 days or major surgeries \< or = 28 days prior to first dose of treatment
References
Publications (1)
- DERIVEDCorr BR, Haggerty A, Gysler SM, Taylor S, Behbakht K, Alldredge J, Lefkowits C, Brubaker LW, Bouts C, Babayan LM, Martin LP, Costello J, Bitler BG, Hu J, Guntupalli SR. A phase II, randomized, double-blind study of the use of rucaparib vs. placebo maintenance therapy in metastatic and recurrent endometrial cancer. Gynecol Oncol. 2025 Sep;200:58-67. doi: 10.1016/j.ygyno.2025.07.008. Epub 2025 Jul 22. PMID 40700852