Cervical CancerPhase 2Clovis-001NCT03476798
Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium
A Phase 2 study testing Rucaparib and Bevacizumab in people with Cervical Cancer and Endometrial Cancer, run by University of Oklahoma at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Cervical Cancer, Endometrial Cancer
- What is being tested?
- Rucaparib and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jun 2018to 29 Sep 2023
- 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically-documented carcinoma of the cervix or endometrium.
- Patients with measurable and/or evaluable lesions as defined by RECIST 1.1.
- Women at least 18 years of age
- 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.
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- Adequate organ function should be confirmed by the following laboratory values obtained ≤ 14 days prior to first dose of rucaparib.
- Patients must have a life expectancy of at least 3 months ((to be able to complete one cycle of study treatment).
- 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.
- Women of childbearing potential must not be considering getting pregnant and must avoid pregnancy during the study and for at least six months after the last dose of rucaparib or longer if requested by local authorities.
Who cannot join
- 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; However patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed >6 months prior and/or bone marrow transplant (BMT) >2 years prior to first dose of rucaparib.
- 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.
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- 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. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with rucaparib and bevacizumab, breastfeeding should be discontinued if the mother is treated with rucaparib and bevacizumab. Should a woman become pregnant or suspect she is pregnant while in this study, she should inform her treating physician immediately.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible drug interactions with rucaparib and bevacizumab.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
University of Minnesota
Minneapolis, Minnesota, 55455
Stephenson Cancer Center, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: A Phase II Trial of Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium
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.
Read the 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
- Being tested
- Rucaparib, Bevacizumab
- Medical subject headings
- Uterine Cervical Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RucaparibDrug
Rucaparib 600mg PO BID daily
BevacizumabDrug
Bevacizumab 15mg/kg IV on day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab + Rucaparib | Experimental | Not described Receives: Drug: Rucaparib; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Who Are Progression-free at 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.
Measured: 6 months
Secondary outcomes (4)
Proportion of Patients Who Had Objective Tumor Response
To estimate the proportion of patients treated with bevacizumab and rucaparib who have objective tumor response (complete or partial)
Measured: up to 2 years
Number of Patients Who Experience Toxicity
To determine the nature and degree of toxicity in combination of rucaparib and bevacizumab (Adverse Event Grade 3 and higher).
Measured: up to 2 year
Median Overall Survival
To estimate the median overall survival of patients treated with combination rucaparib and bevacizumab.
Measured: up to 2 years
Median Progression-free Survival Time
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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start29 Jun 2018
- Primary completion12 May 2020
- Study completion29 Sep 2023
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.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Responsible party
- Sponsor
- Investigators
- Kathleen Moore, MD, Principal investigator, Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03476798
- Sponsor's protocol ID
- OU-SCC-CLOVIS-001
- Acronym
- Clovis-001
- Status last verified
- Feb 2024
- First submitted
- 19 Mar 2018
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium
- ClinicalTrials.gov ID
- NCT03476798
- Acronym / sponsor ID
- Clovis-001 / OU-SCC-CLOVIS-001
- Conditions
- Cervical Cancer, Endometrial Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Clovis Oncology, Inc.
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 26 Mar 2018 (actual)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab + Rucaparib | Experimental | Drug: Rucaparib, Drug: Bevacizumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with histologically-documented carcinoma of the cervix or endometrium.
- Patients with measurable and/or evaluable lesions as defined by RECIST 1.1.
- Women at least 18 years of age
- 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.
Key exclusion criteria (15 listed)
- 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; However patients with a history of malignancy that has been completely treated, with no evidence of that cancer currently, are permitted to enroll in the trial provided all chemotherapy was completed >6 months prior and/or bone marrow transplant (BMT) >2 years prior to first dose of rucaparib.
- 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.
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 |
|---|---|---|
| RucaparibRucaparib 600mg PO BID daily | Drug | Bevacizumab + Rucaparib |
| BevacizumabBevacizumab 15mg/kg IV on day 1 of each cycle | Drug | Bevacizumab + Rucaparib |
Primary outcome
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.
4 secondary outcomes
Proportion of Patients Who Had Objective Tumor Response
Time frame: up to 2 years
Number of Patients Who Experience Toxicity
Time frame: up to 2 year
Median Overall Survival
Time frame: up to 2 years
Median Progression-free Survival Time
Time frame: up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Kathleen Moore, MD principal investigator
Obstetrics and Gynecology
3 sites 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 and Bevacizumab in people with Cervical Cancer and Endometrial Cancer, run by University of Oklahoma at 3 sites 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 11 inclusion and 15 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 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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 28 May 2021). 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?
Proportion of Patients Who Are Progression-free at 6 Months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2024.