NCT03476798

Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium

A Phase II Trial of Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II study of rucaparib, a small molecule inhibitor poly (adenosine diphosphate \[ADP\]-ribose) polymerase (PARP), being tested in combination with bevacizumab in patients with recurrent cervical or endometrial cancer. The objective of this study is to determine the proportion of these patients who survive progression-free for at least 6 months while receiving this drug combination.

Detailed description

Patients who consent to participate in this study will receive treatment with rucaparib and bevacizumab until unacceptable toxicity or tumor progression. Subjects will take one rucaparib pill will be taken twice daily, and bevacizumab will be adimistered via IV onDay 1 of each 21 day cycle. Subjects will receive tests and procedures that are part of regular cancer care as well as those required for the purposes of this study. If there is no cancer found in scans after 6 cycles of treatment, patients may continue with study treatment for 1 year. Follow up visits will occur every 3 months for the first 2 years after treatment is completed and every 6 months for 3 additional years.

Conditions

• Cervical Cancer
• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Rucaparib	Rucaparib 600mg PO BID daily
DRUG	Bevacizumab	Bevacizumab 15mg/kg IV on day 1 of each cycle

Timeline

• Start date: 2018-06-29
• Primary completion: 2020-05-12
• Completion: 2023-09-29
• First posted: 2018-03-26
• Last updated: 2024-02-15
• Results posted: 2021-05-28

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study