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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA046934 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Clovis Oncology, Inc. | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Ingredient | Active Comparator | 1:1 Randomization. Participants in this arm receive the active ingredient medication. |
|
| Placebo | Placebo Comparator | 1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rucaparib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 48 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death. | 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. |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Corr, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40700852 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Ingredient | 1:1 Randomization. Participants in this arm receive the active ingredient medication. Rucaparib: 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. |
| FG001 | Placebo | 1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients). Placebo Oral Tablet: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Ingredient | 1:1 Randomization. Participants in this arm receive the active ingredient medication. Rucaparib: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | 95% Confidence Interval | months | Up to 48 months. |
|
4 years and 8 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Ingredient | 1:1 Randomization. Participants in this arm receive the active ingredient medication. Rucaparib: 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anemia | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bradley Robert Corr, MD | University of Colorado Denver | 303-724-2066 | bradley.corr@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2021 | May 6, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C531549 | rucaparib |
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Active ingredient vs placebo
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|
| Placebo Oral Tablet | Drug | 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. |
|
| Up to 48 months. |
| BG001 | Placebo | 1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients). Placebo Oral Tablet: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients).
Placebo Oral Tablet: 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.
|
|
| Secondary | Overall Survival (OS) | Overall survival is defined as cycle 1 day 1 (C1D1) till the time of death. | Posted | Median | 95% Confidence Interval | months | Up to 48 months. |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Up to 48 months. |
|
|
|
| 1 |
| 39 |
| 3 |
| 39 |
| 37 |
| 39 |
| EG001 | Placebo | 1:1 Randomization. Participants in this arm receive the placebo medication. (Placebos do not contain active ingredients). Placebo Oral Tablet: 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. | 1 | 40 | 1 | 40 | 27 | 40 |
| thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| elevated ALT/AST | Investigations | Systematic Assessment |
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| neutropenia | Investigations | Systematic Assessment |
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| nausea | Gastrointestinal disorders | Systematic Assessment |
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| fatigue | General disorders | Systematic Assessment |
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| anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| thrombocytopenia | Investigations | Systematic Assessment |
|
| elevated ALT/AST | Investigations | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Systematic Assessment |
|
| neutropenia | Investigations | Systematic Assessment |
|
| elevated alkaline phosphatase | Investigations | Systematic Assessment |
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| dizziness | Nervous system disorders | Systematic Assessment |
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| anorexia | Metabolism and nutrition disorders | Systematic Assessment |
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| diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| dry mouth | Gastrointestinal disorders | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| hot flashes | Vascular disorders | Systematic Assessment |
|
| elevated creatinine | Investigations | Systematic Assessment |
|
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |