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Trial record 22 of 49 for:    rucaparib

Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium (Clovis-001)

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ClinicalTrials.gov Identifier: NCT03476798
Recruitment Status : Recruiting
First Posted : March 26, 2018
Last Update Posted : August 27, 2019
Sponsor:
Collaborator:
Clovis Oncology, Inc.
Information provided by (Responsible Party):
University of Oklahoma

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Endometrial Cancer Drug: Rucaparib Drug: Bevacizumab Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Bevacizumab + Rucaparib Drug: Rucaparib
Rucaparib 600mg PO BID daily

Drug: Bevacizumab
Bevacizumab 15mg/kg IV on day 1 of each cycle




Primary Outcome Measures :
  1. Number of patients who survive progression-free [ Time Frame: 6 months ]
    To estimate the proportion of patients treated with bevacizumab who are progression-free.


Secondary Outcome Measures :
  1. Number of patients who have objective tumor response [ Time Frame: 6 months ]
    To estimate the proportion of patients treated with bevacizumab and rucaparib who have objective tumor response (complete or partial)

  2. Number of patients who experience toxicity [ Time Frame: 6 months ]
    To determine the nature and degree of toxicity in combination of rucaparib and bevacizumab.

  3. Number of patients with overall survival [ Time Frame: 5 years ]
    To estimate the overall survival of patients treated with combination rucaparib and bevacizumab.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically-documented carcinoma of the cervix or endometrium.
  • Patients with measurable and/or evaluable lesions as defined by RECIST 1.1.
  • Patients with persistent or recurrent squamous cell or adenocarcinoma of the cervix, or any carcinoma or carcinosarcoma of the endometrium who has undergone at least one prior line of systemic therapy. Prior bevacizumab is allowed. (Note: previous cisplatin during radiation therapy should NOT count as a prior line of systemic therapy).
  • ECOG performance status of 0, 1, or 2.
  • Patients should agree to have tumor biopsy for correlative studies.If the patients are unable to be safely biopsied and desire enrollment, they may be enrolled per principal investigator discretion.
  • Patients must have acceptable organ and marrow function.
  • Patients must have a life expectancy of at least 3 months.
  • Patients should have no major existing co-morbidities or medical conditions that will preclude therapy in the view of the principal investigator.
  • Prior bevacizumab is allowed if off drug ≥ 28 days prior to study enrollment.
  • Female patients of reproductive potential and their male partners must agree to practice total abstinence or use a highly effective method of contraception prior to study entry, during treatment and for 6 months following the last dose of rucaparib.
  • Negative serum pregnancy test result less than 3 days prior to administration of the first dose of rucaparib.

Exclusion Criteria:

  • Patients who have active second malignancy, i.e., patient known to have potentially fatal cancer present for which she may be (but not necessarily) currently receiving treatment.
  • Prior treatment with any PARP inhibitor.
  • Untreated or symptomatic central nervous system (CNS) metastases.
  • Patients with asymptomatic CNS metastases are eligible provided they have been clinically stable for at least 4 weeks.
  • Patients who have received treatment with chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C); or radiation, biologic/targeted agents, experimental drugs within 3 weeks prior to first dose of rucaparib; and/or ongoing adverse effects from such treatment > NCI CTCAE Grade 1 (Grade 2 non-hematologic toxicity to most recent treatment may be permitted with prior advanced approval from Sponsor).
  • Hospitalization for bowel obstruction within 3 months prior to enrollment.
  • Patients must have no history of gross hemoptysis (defined as bright red blood of a ½ teaspoon or more) or coagulopathy.
  • Patients with history of major tumor-related bleeding that is not controlled despite locoregional treatment or at high risk of recurrent tumor-related bleeding will be excluded.
  • Patients with history of hypertension must be well-controlled (≤150/100) on a stable regimen of anti-hypertensive therapy.
  • Patients with tumors that invaded major vessels (e.g. the carotid) as shown unequivocally by imaging studies will be excluded due to the possibility of increased risk for tumor bleeding with bevacizumab therapy.
  • Patients should not have a major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study.
  • No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to registration. No serious non-healing wound, ulcer, or bone fracture.
  • Patients should not have unstable angina or myocardial infarction within the previous 6 months; no uncontrolled hypertension; no symptomatic congestive heart failure; no serious cardiac arrhythmia requiring medication; no clinically significant peripheral vascular disease; no history of any CNS cerebrovascular ischemia or stroke within the last 6 months; no active serious infection.
  • Patients should not have other coexisting medical condition that would preclude full compliance with the study.
  • Patients may not be receiving any other investigational agents.
  • Patients should not have a history of prior severe infusion reaction to a monoclonal antibody. Patients with known hypersensitivity of Chinese hamster ovary cell products or other recombinant human antibodies.
  • Pregnant women are excluded from this study because rucaparib and bevacizumab have the potential for teratogenic or abortifacient effects.
  • Patients who are breast feeding should discontinue before going on study.
  • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible drug interactions with rucaparib and bevacizumab.

Information from the National Library of Medicine

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


Contacts
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Contact: Lead Gyn Onc Nurse 405 271-8777 SCC-IIT-Office@ouhsc.edu

Locations
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United States, Oklahoma
Stephenson Cancer Center, University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73117
United States, Virginia
University of Virginia Cancer Center Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Sheena Clift    434-924-7780      
Principal Investigator: Leigh Cantrell, MD         
Sponsors and Collaborators
University of Oklahoma
Clovis Oncology, Inc.
Investigators
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Principal Investigator: Camille Gunderson, MD Obstetrics and Gynecology

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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT03476798     History of Changes
Other Study ID Numbers: OU-SCC-Clovis-001
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rucaparib
Endometrial Neoplasms
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action