Metastatic Endometrial CancerPhase 2NCT03617679
Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
A Phase 2 study testing Rucaparib in people with Metastatic Endometrial Cancer, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Metastatic Endometrial Cancer
- What is being tested?
- Rucaparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 27 Feb 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be a female aged 18-89.
- Patients with a primary Stage III/IV or recurrent endometrial cancer.
- Patients have received at least one prior chemotherapy regimen and no more than two prior cytotoxic regimens (including hormonal therapy).
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- Primary chemotherapy regimen must have consisted of at least 4 completed cycles and no more than 8 completed cycles.
- Previous cytotoxic regimen at least 4 weeks before initiation and no more than 8 weeks from initiation after last dose of previous therapy.
- 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Absolute neutrophil count (ANC) > or = 1500 cells/microliters
- Platelet count > 100,000 microliters
- Hemoglobin > or = 9.0 g/dL
- Serum albumin > or = 2.5 g/dL
- Total bilirubin ≤ 1.5 x ULN (uppler limit of normal)
- AST and ALT ≤ 3.0 x ULN
- Serum Creatinine ≤ 1.5x ULN
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to comply with study and follow-up procedures
- 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
- 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
- Participation in investigational clinical trial within last 30 days
- History of significant chronic disease including HIV/AIDS or hepatitis C
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- Inability to provide informed consent
- Known central nervous system (CNS) malignancy or CNS metastases
- 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.
- History of stroke or transient ischemic attack (TIA) within 3 months prior to cycle 1 day 1(C1D1)
- Women with prognosis for survival less than 6 months
- Patients who have progressed or have stable disease (SD) through most recent chemotherapy regimen
- Patients deemed otherwise clinically unfit for clinical trial per Investigator's discretion
- Patients with duodenal stent or other GI disorder/defect that would interfere with absorption of oral medication
- Female patients who maintain fertility potential and refuse to comply to use contraception and be followed for pregnancy by pregnancy testing
- Minor surgical procedure < or = 14 days or major surgeries < or = 28 days prior to first dose of treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
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.
Read the detailed description
This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.
- Conditions
- Metastatic Endometrial Cancer
- Being tested
- Rucaparib, Placebo Oral Tablet
- Keywords
- Rucaparib, Placebo, Randomized, Double Blind, Stage III/IV
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RucaparibDrug
Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
Placebo Oral TabletDrug
Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
| Study group | Role | What they receive |
|---|---|---|
| Active Ingredient | Active comparator | 1:1 Randomization. Participants in this arm receive the active ingredient medication. Receives: Drug: Rucaparib |
| Placebo | Placebo comparator | 1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients). Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Progression free survival is defined as cycle 1 day 1 (C1D1) till the time of progression as determined by RECIST 1.1 criteria or death.
Measured: Up to 48 months.
Secondary outcomes (2)
Overall Survival (OS)
Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death.
Measured: Up to 48 months.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Safety and tolerability analysis of Rucaparib will be summarized by dose and severity as assessed by the Common Toxicity Criteria for Adverse Events (CTCAE) version 5 and relationship to study drug.
Measured: Up to 48 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start6 Mar 2019
- Primary completion31 Oct 2023
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active ingredient vs placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Clovis Oncology, Inc., National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Bradley Corr, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03617679
- Sponsor's protocol ID
- 18-0567.cc
- Other IDs
- P30CA046934
- Status last verified
- Mar 2026
- First submitted
- 17 Jul 2018
- Last updated
- 24 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Corr 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.
PubMed 40700852
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind Study of the Use of Rucaparib vs. Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
- ClinicalTrials.gov ID
- NCT03617679
- Acronym / sponsor ID
- 18-0567.cc
- Conditions
- Metastatic Endometrial Cancer
- Keywords
- Rucaparib, Placebo, Randomized, Double Blind, Stage III/IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Clovis Oncology, Inc., National Cancer Institute (NCI)
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Posted 1 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a phase II clinical trial, that administers a maintenance treatment after first line chemotherapy is complete. It is designed to have a 1:1 randomization technique. Half the participants who enter the study will receive the active ingredient, Rucaparib, while the other half will receive a placebo. Treatment will be until progression with follow up until death.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Active ingredient vs placebo
| Arm | Type | Receives |
|---|---|---|
| Active Ingredient | Active comparator | Drug: Rucaparib1:1 Randomization. Participants in this arm receive the active ingredient medication. |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients). |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be a female aged 18-89.
- Patients with a primary Stage III/IV or recurrent endometrial cancer.
Key exclusion criteria (16 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Inability to comply with study and follow-up procedures
- 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
- 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
- Participation in investigational clinical trial within last 30 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RucaparibParticipants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water. | Drug | Active Ingredient |
| Placebo Oral TabletParticipants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water. | Drug | Placebo |
Primary outcome
Progression Free Survival (PFS)
Time frame: Up to 48 months.
Progression free survival is defined as cycle 1 day 1 (C1D1) till the time of progression as determined by RECIST 1.1 criteria or death.
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to 48 months.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 48 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40700852Corr 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley Corr, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rucaparib in people with Metastatic Endometrial Cancer, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: Up to 48 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03617679, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.