Ovarian CancerPhase 2NCT02278783
Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer
A Phase 2 study testing regorafenib in people with Ovarian Cancer and Primary Peritoneal Cancer, run by University of Utah at 1 site in United States.
Trial summary
This will be a non-blinded, single arm study to test the efficacy of Regorafenib in patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
- What is being tested?
- regorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jan 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years. Life expectancy of at least 12 weeks (3 months). Diagnosis of recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer. Histologic or cytologic confirmation of the original primary tumor is required.
- Patients must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter (LD) greater than or equal to 10 mm using CT, MRI, or caliper measurements or greater than or equal to 20 mm with x-ray.
- Patients must have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1.
- Prior therapy: Patients must have had at least one prior platinum-based chemotherapeutic regimen for management of primary disease containing Carboplatin, Cisplatin, or another organo-platinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents (including anti-angiogenesis agents) or extended therapy (i.e. maintenance therapy) administered after surgical or non-surgical assessment.
- Patients are allowed to have previously received, but are not required to receive, one or two additional cytotoxic regimens for management of recurrent disease.
- Patients who have received only one prior cytotoxic regimen (platinum based regimen for management of primary disease), must have a platinum-free interval of at least 6 months.
- Patients must not have received any non-cytotoxic therapy for management of recurrent or persistent disease, except hormonal based therapy is allowed. Patients are allowed to have previously received, but are not required to have received non-cytotoxic therapy as part of their primary treatment regimen.
- ECOG score of 0-1. Adequate bone marrow, liver and renal function
Who cannot join
- Patients who have progressed during initial platinum-based therapy in the upfront setting, who have persistent disease after this initial platinum-based therapy, or who have recurrence less than 6 months from adjuvant chemotherapy are excluded.
- Major surgical procedure or significant traumatic injury within 28 days before start of study medication.
- Patients who have received wide field radiotherapy less than or equal to 4 weeks or limited field radiation for palliation less than or equal to 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) greater than or equal to 5 effective half-lives prior to starting study drug or who have not recovered from side effects of such therapy.
- Patients who have received chemotherapy or targeted anticancer therapy greater than or equal to 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C, and 1 week for hormone therapy) prior to starting study drug or who have not recovered from side effects of such therapy.
- Active concurrent primary malignancy or prior malignancies occurring within 3 years (except cervical carcinoma in-situ, treated basal cell carcinoma, or superficial bladder tumor.
- Use of any investigational drugs, biologics, or devices within 28 days prior to study enrollment.
Show all 13Show fewer
- Prior use of regorafenib. Strong inducers and inhibitors of CYP3A4 and therapeutic anticoagulation with Vitamin-K antagonists (e.g. warfarin) or with heparins and heparinoids Women who are pregnant or breastfeeding. Uncontrolled hypertension defined as systolic pressure greater than or equal to 140 mmHg or diastolic pressure greater than or equal to 90 mmHg despite optimal medical management.
- Human immunodeficiency virus (HIV) positive diagnosis with a CD4 count of <100 mm3 or detectable viral load within the past 3 months, and is receiving combination anti-retroviral therapy.
- Active or clinically significant cardiac disease Evidence or history of bleeding diathesis or coagulopathy Any hemorrhage or bleeding event ≥ NCI CTCAE v4.0 Grade 3 within 4 weeks prior to start of study medication.
- Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of start of study treatment.
- Patients with pheochromocytoma Symptomatic metastatic brain or meningeal tumors. Ongoing infection Presence of a non-healing wound, non-healing ulcer, or bone fracture Patient's with a history of kidney disease or persistent proteinuria must have less than Grade 3 proteinuria per NCI CTCAE v4.0 at screening.
- Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of drug (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
This will be a non-blinded, single arm study to test the efficacy of Regorafenib in patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer.
- Being tested
- regorafenib
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regorafenibDrug
Patients will be treated with Regorafenib 160 mg (4 x 40 mg tablets) daily for 21 days of a 28 day cycle (three weeks on drug, one week off) until disease progression or adverse effects prohibit further treatment
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib Treatment arm, all patients | Experimental | Not described Receives: Drug: regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Month Progression Free Survival (PFS)
To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers
Measured: Patients will be checked for PFS after 6 months on treatment
Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported.
Measured: Patients will remain on treatment for approximately 4-6 months on average.
Secondary outcomes (2)
Estimate Progression Free Survival
To estimate progression free survival for patients treated with this regimen
Measured: At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months
Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response)
To determine the frequency of clinical benefit (stable disease, partial, and complete response) according to RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria
Measured: Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2016
- Study completionJan 2017
Why it stopped: Slow Accrual
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 Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02278783
- Sponsor's protocol ID
- HCI77685
- Status last verified
- Sep 2017
- First submitted
- 23 Oct 2014
- Last updated
- 6 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Trial of Regorafenib in Patients With Recurrent Ovarian, Primary Peritoneal and Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT02278783
- Acronym / sponsor ID
- HCI77685
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Oct 2014 (estimated)
- Results
- Posted 2 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a non-blinded, single arm study to test the efficacy of Regorafenib in patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regorafenib Treatment arm, all patients | Experimental | Drug: regorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age greater than or equal to 18 years. Life expectancy of at least 12 weeks (3 months). Diagnosis of recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer. Histologic or cytologic confirmation of the original primary tumor is required.
- Patients must have measurable disease defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter (LD) greater than or equal to 10 mm using CT, MRI, or caliper measurements or greater than or equal to 20 mm with x-ray.
- Patients must have at least one target lesion to be used to assess response on this protocol as defined by RECIST 1.1.
- Prior therapy: Patients must have had at least one prior platinum-based chemotherapeutic regimen for management of primary disease containing Carboplatin, Cisplatin, or another organo-platinum compound. This initial treatment may have included intraperitoneal therapy, consolidation, non-cytotoxic agents (including anti-angiogenesis agents) or extended therapy (i.e. maintenance therapy) administered after surgical or non-surgical assessment.
- Patients are allowed to have previously received, but are not required to receive, one or two additional cytotoxic regimens for management of recurrent disease.
Key exclusion criteria (13 listed)
- Patients who have progressed during initial platinum-based therapy in the upfront setting, who have persistent disease after this initial platinum-based therapy, or who have recurrence less than 6 months from adjuvant chemotherapy are excluded.
- Major surgical procedure or significant traumatic injury within 28 days before start of study medication.
- Patients who have received wide field radiotherapy less than or equal to 4 weeks or limited field radiation for palliation less than or equal to 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) greater than or equal to 5 effective half-lives prior to starting study drug or who have not recovered from side effects of such therapy.
- Patients who have received chemotherapy or targeted anticancer therapy greater than or equal to 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C, and 1 week for hormone therapy) prior to starting study drug or who have not recovered from side effects of such therapy.
- Active concurrent primary malignancy or prior malignancies occurring within 3 years (except cervical carcinoma in-situ, treated basal cell carcinoma, or superficial bladder tumor.
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 |
|---|---|---|
| regorafenibPatients will be treated with Regorafenib 160 mg (4 x 40 mg tablets) daily for 21 days of a 28 day cycle (three weeks on drug, one week off) until disease progression or adverse effects prohibit further treatment | Drug | Regorafenib Treatment arm, all patients |
Primary outcome
6 Month Progression Free Survival (PFS)
Time frame: Patients will be checked for PFS after 6 months on treatment
To evaluate the anti-tumor activity of Regorafenib as measured by progression free survival at 6 months in patients with recurrent gynecological cancers
Incidence of Adverse Events (Grade 2 or Higher), Assessed According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: Patients will remain on treatment for approximately 4-6 months on average.
To determine the nature and degree of toxicity of Regorafenib in this cohort of patients. Toxicity will be summarized by attribution: regorafenib-related adverse events grade 2 or higher will be reported.
2 secondary outcomes
Estimate Progression Free Survival
Time frame: At 6 months patients will be checked for PFS, and compared to the expected probability of the patient being alive and progression-free for at least 6 months
Frequency of Clinical Benefit (Stable Disease, Partial and Complete Response)
Time frame: Scans will be done every 2 cycles (every 2 months) for disease assessment. Patients on average will be on treatment for 4-6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Ovarian Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing regorafenib in people with Ovarian Cancer and Primary Peritoneal Cancer, run by University of Utah at 1 site 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 Dec 2016). 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?
6 Month Progression Free Survival (PFS) (time frame: Patients will be checked for PFS after 6 months on treatment). The study lists 2 primary outcomes in all. 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 6 Oct 2017.