Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium (Clovis-001)
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|ClinicalTrials.gov Identifier: NCT03476798|
Recruitment Status : Active, not recruiting
First Posted : March 26, 2018
Results First Posted : May 28, 2021
Last Update Posted : July 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Endometrial Cancer||Drug: Rucaparib Drug: Bevacizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium|
|Actual Study Start Date :||June 29, 2018|
|Actual Primary Completion Date :||May 12, 2020|
|Estimated Study Completion Date :||February 2023|
|Experimental: Bevacizumab + Rucaparib||
Rucaparib 600mg PO BID daily
Bevacizumab 15mg/kg IV on day 1 of each cycle
- Proportion of Patients Who Are Progression-free at 6 Months [ Time Frame: 6 months ]
To estimate the proportion of pts treated w/bevacizumab who are progression-free.
Progression for measurable disease per RECIST v1.1. Progression for pts with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
- Proportion of Patients Who Had Objective Tumor Response [ Time Frame: up to 2 years ]To estimate the proportion of patients treated with bevacizumab and rucaparib who have objective tumor response (complete or partial)
- Number of Patients Who Experience Toxicity [ Time Frame: up to 2 year ]To determine the nature and degree of toxicity in combination of rucaparib and bevacizumab (Adverse Event Grade 3 and higher).
- Median Overall Survival [ Time Frame: up to 2 years ]To estimate the median overall survival of patients treated with combination rucaparib and bevacizumab.
- Median Progression-free Survival Time [ Time Frame: up to 2 years ]To estimate the progression-free survival (PFS) of patients with persistent or recurrent cervical or endometrial cancer treated with combination rucaparib and bevacizumab Progression for measurable disease per RECIST v1.1 Progression for patients with non-measurable disease at baseline is defined as increasing clinical, radiological, or histological evidence of disease since study entry.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476798
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Oklahoma|
|Stephenson Cancer Center, University of Oklahoma Health Sciences Center|
|Oklahoma City, Oklahoma, United States, 73117|
|United States, Virginia|
|University of Virginia Cancer Center|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Kathleen Moore, MD||Obstetrics and Gynecology|