Ovarian CancerPhase 2NCT01972516
Tivozanib As Maintenance Therapy In GYN
A Phase 2 study testing Tivozanib in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research study is evaluating a drug called tivozanib as a possible treatment for ovarian, fallopian tube or primary peritoneal cancer. Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and spread. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Tivozanib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jan 2016
- 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
- No evidence of disease on CT/MRI following treatment for recurrent ovarian, fallopian tube, or peritoneal cancer.
- High-grade papillary serous carcinoma of the ovary, fallopian tube or peritoneum. Histological confirmation of the original primary tumor is required.
- CA-125 within normal range.
- Age greater than or equal to 18 years.
- 1 prior line of therapy (cytotoxic therapy only) in the recurrent setting is allowed. Bevacizumab in the upfront setting allowed, however Bevacizumab or other VEGF pathway targeted therapy in the recurrent setting is not allowed. Hormonal therapy does not count as a prior line.
- Recovered from effects of recent surgery, radiotherapy, and chemotherapy.
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- ECOG performance status ≤ 2
- Organ and marrow function as defined below:
- Absolute neutrophil count ≥1,250/mcL
- Platelets ≥100,000/mcL
- Bilirubin ≤ 1.5 x ULN
- AST (SGOT) / ALT (SGPT) ≤ 2.5 x institutional upper limit of normal Alkaline phosphatase ≤ to 2.5 x ULN
- Creatinine ≤ 1.5 x institutional upper limit
- Less than or equal to 1+ proteinuria on two consecutive dipsticks taken no less than 1 week apart, or < 1 gm protein on 24-hour urine collection or a urine protein:creatinine ratio of < 1.
- INR < 1.5; if on anticoagulation: INR is required to be between 2 and 3.
- Patient must receive one of these three regimens for their platinum sensitive disease (number of cycles should not have exceeded 8 cycles of 1 regimen in the recurrent setting):
- Platinum (Carboplatin or Cisplatin) and Taxane (Paclitaxel or Docetaxel) Carboplatin and Gemcitabine
- Carboplatin and Liposomal Doxorubicin
- Females not of childbearing potential or has documentation of a negative pregnancy test prior to the start of the study treatment are eligible. Sexually active pre-menopausal female subjects must agree to use adequate, highly effective contraceptive measures, while on study and for 45 days after the last dose of last study drug. Effective birth control includes (a) intrauterine device (IUD) plus one barrier method; (b) oral, implantable or injectable contraceptives plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
- Able and willing to sign a written informed consent document.
Who cannot join
- Prior therapy with bevacizumab or other VEGF pathway targeted therapy in the recurrent setting. Bevacizumab in the upfront setting is allowed.
- Receiving any other study agents.
- Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible. Subjects with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible. Subjects with any other concomitant or prior malignancies are ineligible.
- Serious non-healing wounds or ulcers at the time of registration.
- History of abdominal fistula or gastrointestinal perforation.
- Active bleeding.
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- Clinically significant cardiovascular disease.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Tivozanib.
- Symptomatic left ventricular dysfunction or baseline left ventricular ejection fraction (LVEF) by multigated acquisition scan (MUGA) or echocardiogram (ECHO) ≤ 50 % lower limit of institutional normal (LLN).
- Uncontrolled hypertension: systolic blood pressure of >140 mmHg or diastolic blood pressure of >90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart.
- Myocardial infarction, severe angina, or unstable angina within 6 months prior to administration of first dose of study drug.
- History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation).
- Cardiac arrhythmias requiring anti-arrhythmic medications (except for atrial fibrillation that is well controlled with anti-arrhythmic medication).
- Coronary or peripheral artery bypass graft within 6 months of screening.
- History of Class III or IV congestive heart failure, as defined by the New York Heart Association.
- Central nervous system metastases.
- Note: Subjects with previously treated (radiotherapy or surgery) brain metastasis that have been stable without steroid treatment for at least 3 months following prior treatment may be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase II Study of Tivozanib as Maintenance Therapy, Post-Chemotherapy, in Patients With Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This research study is evaluating a drug called tivozanib as a possible treatment for ovarian, fallopian tube or primary peritoneal cancer.
Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood supply so that it does not get the blood and nutrients it needs to grow.
In this research study, the Investigators are looking to see whether tivozanib works as a maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in participants who have achieved a complete response following chemotherapy. Maintenance therapy is given after a disease has responded to previous treatment. It is given to help prevent the spread or recurrence of the tumor.
Read the detailed description
Once the participant has signed the consent form, they will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant do not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- Performance status, which evaluates how the participant is able to carry on with their usual activities.
- A tumor assessment by CT (Computerized Tomography) scan or MRI (Magnetic Resonance Imaging.
- Blood tests.
- Urine test.
- Electrocardiogram (ECG)
If these tests show that the participant is eligible to participate in the research study, the participant will begin the study treatment. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
Additional research procedures to be performed during this study:
- Archival tumor testing: During this study, additional tests will be performed on a sample of the participant's original tumor that has been stored in the institution's tissue banks. These tests will be performed on tumor tissue samples from previous biopsies or surgeries for the participant's cancer.
The research done on these samples will involve looking at DNA and proteins in the participant's cancer to see if researchers can learn more about the participant's type of cancer and understand how tivozanib might work on their tumor. Testing of this sample will not require the participant to undergo any additional research procedures.
This research sample collection is a required part of this research study.
Tissue collection / Ownership: Participation in this protocol involves providing specimen(s) of participant's tissue. Please know that if the investigator leaves the institution, the research and the tissue might remain at the DF/HCC or might be transferred to another institution.
After the screening procedures confirm that the participant are eligible to participate in the research study:
If the participant takes part in this research study, the participant will be randomized to receive tivozanib by mouth or no therapy. The participant will be given a study drug diary for each treatment if the participant is randomized to the tivozanib group.
Each treatment cycle lasts 28 days (4 weeks). For participants who are randomized to receive tivozanib, the participant will be taking the study drug once per day for 3 weeks followed by a week of rest. The diary will also include special instructions for taking the study drug. The study drug will be taken once a day with plenty of water.
- Being tested
- Tivozanib
- Keywords
- Platinum-Sensitive, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous
- 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.
TivozanibDrug
Also called Tivozanib hydrochloride, AV-951
| Study group | Role | What they receive |
|---|---|---|
| Tivozanib | Experimental | Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities. Receives: Drug: Tivozanib |
| Standard Care | No intervention | Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS) Comparison
To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)
Measured: 2 Years
Secondary outcomes (4)
Progression-Free Survival (PFS) Evaluation
To evaluate progression-free survival with no maintenance therapy in patients who have achieved a complete response following therapy for platinum sensitive disease.
Measured: 2 Years
Overall Survival (OS) Evaluation
To evaluate the overall survival with and without maintenance therapy with Tivozanib in patients who have achieved a complete response following therapy for platinum sensitive disease.
Measured: 2 Years
Toxicity Rate Comparison
To compare rates of toxicity with and without maintenance therapy with Tivozanib.
Measured: 2 Years
Quality of Life (QOL) Evaluation
To evaluate the impact of treatment with Tivozanib versus placebo alone on the Quality of Life (QOL) through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC QLQ-Ovarian Cancer Module (EORTC QLQ-OV28) for functioning and symptoms.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2015
- Study completionJan 2016
Why it stopped: due to 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network, AVEO Pharmaceuticals, Inc.
- Responsible party
- Principal investigator, Susana M. Campos, MD, Dana-Farber Cancer Institute
- Investigators
- Susana Campos, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972516
- Sponsor's protocol ID
- 13-375
- Status last verified
- May 2017
- First submitted
- 24 Oct 2013
- Last updated
- 5 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
PubMed 37185961
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Tivozanib as Maintenance Therapy, Post-Chemotherapy, in Patients With Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT01972516
- Acronym / sponsor ID
- 13-375
- Keywords
- Platinum-Sensitive, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, High-grade Serous
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: due to slow accrual
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network, AVEO Pharmaceuticals, Inc.
- Study start
- Nov 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Oct 2013 (estimated)
- Results
- Posted 24 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is evaluating a drug called tivozanib as a possible treatment for ovarian, fallopian tube or primary peritoneal cancer.
Angiogenesis is the formation of new blood vessels. Tumors need blood vessels to grow and spread. Tivozanib is an anti-angiogenesis medicine that fights cancer by cutting off a tumor's blood supply so that it does not get the blood and nutrients it needs to grow.
In this research study, the Investigators are looking to see whether tivozanib works as a maintenance therapy for ovarian, fallopian tube or primary peritoneal carcinoma in participants who have achieved a complete response following chemotherapy. Maintenance therapy is given after a disease has responded to previous treatment. It is given to help prevent the spread or recurrence of the tumor.
Detailed description
Once the participant has signed the consent form, they will be asked to undergo some screening tests or procedures to find out if the participant can be in the research study. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that the participant do not take part in the research study. If the participant has had some of these tests or procedures recently, they may or may not have to be repeated.
- A medical history, which includes questions about the participant's health, current medications, and any allergies.
- Performance status, which evaluates how the participant is able to carry on with their usual activities.
- A tumor assessment by CT (Computerized Tomography) scan or MRI (Magnetic Resonance Imaging.
- Blood tests.
- Urine test.
- Electrocardiogram (ECG)
If these tests show that the participant is eligible to participate in the research study, the participant will begin the study treatment. If the participant does not meet the eligibility criteria, the participant will not be able to participate in this research study.
Additional research procedures to be performed during this study:
- Archival tumor testing: During this study, additional tests will be performed on a sample of the participant's original tumor that has been stored in the institution's tissue banks. These tests will be performed on tumor tissue samples from previous biopsies or surgeries for the participant's cancer.
The research done on these samples will involve looking at DNA and proteins in the participant's cancer to see if researchers can learn more about the participant's type of cancer and understand how tivozanib might work on their tumor. Testing of this sample will not require the participant to undergo any additional research procedures.
This research sample collection is a required part of this research study.
Tissue collection / Ownership: Participation in this protocol involves providing specimen(s) of participant's tissue. Please know that if the investigator leaves the institution, the research and the tissue might remain at the DF/HCC or might be transferred to another institution.
After the screening procedures confirm that the participant are eligible to participate in the research study:
If the participant takes part in this research study, the participant will be randomized to receive tivozanib by mouth or no therapy. The participant will be given a study drug diary for each treatment if the participant is randomized to the tivozanib group.
Each treatment cycle lasts 28 days (4 weeks). For participants who are randomized to receive tivozanib, the participant will be taking the study drug once per day for 3 weeks followed by a week of rest. The diary will also include special instructions for taking the study drug. The study drug will be taken once a day with plenty of water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tivozanib | Experimental | Drug: TivozanibTivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities. |
| Standard Care | No intervention | –Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- No evidence of disease on CT/MRI following treatment for recurrent ovarian, fallopian tube, or peritoneal cancer.
- High-grade papillary serous carcinoma of the ovary, fallopian tube or peritoneum. Histological confirmation of the original primary tumor is required.
- CA-125 within normal range.
- Age greater than or equal to 18 years.
- 1 prior line of therapy (cytotoxic therapy only) in the recurrent setting is allowed. Bevacizumab in the upfront setting allowed, however Bevacizumab or other VEGF pathway targeted therapy in the recurrent setting is not allowed. Hormonal therapy does not count as a prior line.
Key exclusion criteria (17 listed)
- Prior therapy with bevacizumab or other VEGF pathway targeted therapy in the recurrent setting. Bevacizumab in the upfront setting is allowed.
- Receiving any other study agents.
- Subjects with treated limited stage basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the breast or cervix are eligible. Subjects with prior cancer treated with a curative intent with no evidence of recurrent disease 5 years following diagnosis and judged by the investigator to be at low risk of recurrence are eligible. Subjects with any other concomitant or prior malignancies are ineligible.
- Serious non-healing wounds or ulcers at the time of registration.
- History of abdominal fistula or gastrointestinal perforation.
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 |
|---|---|---|
| TivozanibAlso: Tivozanib hydrochloride, AV-951 | Drug | Tivozanib |
Primary outcome
Progression-Free Survival (PFS) Comparison
Time frame: 2 Years
To compare progression-free survival of maintenance therapy with Tivozanib against standard of care in patients with ovarian, fallopian tube or primary peritoneal carcinoma who have achieved a complete response following therapy for platinum sensitive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1)
4 secondary outcomes
Progression-Free Survival (PFS) Evaluation
Time frame: 2 Years
Overall Survival (OS) Evaluation
Time frame: 2 Years
Toxicity Rate Comparison
Time frame: 2 Years
Quality of Life (QOL) Evaluation
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37185961Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.
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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.
Susana Campos, MD, MPH principal investigator
Dana-Farber Cancer Institute
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 Tivozanib in people with Ovarian Cancer and Fallopian Tube Cancer, run by Dana-Farber Cancer Institute 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 20 inclusion and 17 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 5 Jun 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 24 Aug 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?
Progression-Free Survival (PFS) Comparison (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01972516, which also lists 1 linked publication.
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 5 Jun 2017.