Renal Cell CarcinomaPhase 2NCT01834183
Tivozanib + Gemcitabine in Metastatic RCC
A Phase 2 study testing Tivozanib and Gemcitabine in people with Renal Cell Carcinoma, run by Dana-Farber Cancer Institute at 4 sites in United States.
Trial summary
This research study is a PHase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is being studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Tivozanib and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2013to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed renal cell carcinoma that is metastatic
- Failed at least one prior VEGF-targeted therapy
- Prior immunotherapy and mTOR inhibitors are allowed
- Evidence of unidimensionally measurable disease based on RECIST 1.1 criteria, with at least 1 measurable lesion
- Willing to use adequate contraceptive measures while on study and for 30 days after the lst dose of study drug
- For Segment 2, must have evidence of progressive disease
- For Segment 2, amenable to start Gemcitabine chemotherapy within 6 weeks of progression on Tivozanib
- For Segment 2, willing to undergo pre/post therapy biopsy of a metastatic lesion if safe and amenable
Who cannot join
- Prior gemcitabine or tivozanib
- Anticipated need for major surgical procedure during the course of the study
- Pregnant or breastfeeding
- Known prior history of hypertensive crisis or hypertensive encephalopathy
- Primary central nervous system malignancies or leptomeningeal metastases
- Significant cardiac disease
Show all 14Show fewer
- Subjects on warfarin
- Uncontrolled intercurrent illness
- Evidence of bleeding diathesis or known coagulopathy
- Serious, non-healing wound, ulcer or bone fracture
- Psychiatric illness/social situation that would limit compliance with study requirements
- Previous or concurrent malignancy requiring active systemic therapy, < 4 years
- Inability to swallow pills, malabsorption syndrome or gastrointestinal disease that severely affects the absorption of tivozanib, major resection of the stomach or small bowel, or gastric bypass procedure
- Ongoing use of strong CYP3A4 inducers
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Phase II and Biomarker Study of Tivozanib With Gemcitabine Addition Upon Progression in Patients With Metastatic Refractory Renal Cell Carcinoma
This research study is a PHase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved these drugs or combination of drugs for use in participants, including people with your type of cancer.
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. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow the growth of cancer cells.
Read more
Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research suggests combining gemcitabine with tivozanib may have some effectiveness in treating metastatic renal cell carcinoma.
The purpose of this research study is to determine the effectiveness of tivozanib as a treatment for renal cell carcinoma. The purpose of this research study is to also determine if the combination of tivozanib and gemcitabine is effective in treating your type of cancer if your cancer becomes unresponsive or gets worse with tivozanib as treatment alone. The safety of the combination of tivozanib and gemcitabine will also wbe studied.
Another goal of this research study is to learn more about how tivozanib alone and the combination of tivozanib and gemcitabine may work to treat renal cell carcinoma. During the research study we will perform blood tests to measure the level of substances in the blood such as proteins (biomarkers) that may predict who will respond to treatment with tivozanib and gemcitabine.
Read the detailed description
If you agree to participate in this study you will be asked to undergo some screening tests and procedures to confirm that you are eligible. 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 you do not take part in this study. If you have had some of these tests and procedures recently, they may or may not need to be repeated. The screening process will include the following: medical history, physical examination, measurement of vital signs, performance status assessment, electrocardiogram (EKG), echocardiogram (ECHO), CT or MRI, routine blood tests, urine sample, blood pregnancy test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
This study is broken into two segments. In the first segment, you will receive tivozanib alone. Every 28 days in this study is called a study "cycle". You will come to clinic once every 28 days (once a month), on 'day 1' of each 28 day cycle.
Tivozanib is a pill that you take by mouth. You will take it once per day, in the morning, with a glass of water, with or without food. You will take tivozanib days 1-21 (the first three weeks) of each 28 day treatment cycle. You will be given a Study Drug Administration Diary to keep a brief record of the date and time when you take your dose of tivozanib. The study staff will explain to you how to complete your diary. This will be reviewed during yur visits by your doctor or a member of the study staff. This diary will be collected at your visit at the end of each cycle, and a new one will be given to you at the start of the next cycle. You will also have a pre-dose research blood draw (approximately 8 teaspoons of blood will be drawn) prior to your first dose of tivozanib, and after your first cycle of tivozanib. Your samples will not have personal information about you (such as your name and address) on them.
On Day 1 of every cycle you will have: a medical history, physical exam, measurement of your vital signs, performance status assessment, routine blood tests to monitor your health, urine sample. Every other cycle (prior to cycle 3, 5, 7 etc). you will have a CT or MRI scan, EKG, ECHO.
If your cancer gets worse while receiving tivozanib alone you may be eligible to participate in segment 2 of the study and receive tivozanib in combination with gemcitabine. You will come to the clinic on days 1 and 8 of each 28 day cycle.
Gemcitabine will be given through a vein (intravenously, or IV) over a period of 30 minutes at the study clinic. This is called an infusion. You will receive the gemcitabine on days 1 and 8 of each treatment cycle.
You will also have a pre-dose research blood draw (approximately 8 teaspoons of blood will be drawn) prior to your first cycle of tivozanib and gemcitabine in combination, after your first 28 days cycle of tivozanib and gemcitabine in combination, and if your cancer gets worse while receiving tivozanib and gemcitabine in combination. Your samples will not have personal information about you (such as your name and address) on them.
If your doctor determines it is safe for you to have a biopsy, you will undergo a fresh tumor biopsy at the following time points: Prior to receiving your first 28 day cycle of tivozanib and gemcitabine in combination; and after two 28 day cycles (roughly 2 months) of receiving tivozanib and gemcitabine in combination.
On Days 1 and 8 and at the end of study treatment you will undergo a medical history, physical examination, measurement of vital signs, performance status assessment, routine blood tests and a urine sample.
If an unexpected or unwanted event happens during the study, you may be asked to have some extra tests or measurements. Some of the tests or measurements done during the study may have to be repeated if the results are not usable or are abnormal. If additional visits are required during your participation in this study, your study doctor may perform the following procedures and evaluations: medical history, vital sign measurements, physical exam, ECG, performance status, blood and urine tests and/or a review of your study drug administration diary.
We would like to keep track of your medical condition indefinitely. If we do not hear from you, we would like to do this by calling no more than every three months to see how you are doing. Keeping in touch with you and checking your condition helps us look at the long-term effects of the research.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Tivozanib, Gemcitabine
- Keywords
- Metastatic
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TivozanibDrug
Also called AV-951
GemcitabineDrug
| Study group | Role | What they receive |
|---|---|---|
| Tivozanib/Gemcitabine | Experimental | Segment 1: Tivozanib, taken orally days 1-21 of each 28 day cycle. Segment 2: Tivozanib, taken orally days 1-21 of each 28 day cycle. Gemcitabine, taken intravenously, Days 1 and 8 of each 28 day cycle. Receives: Drug: Tivozanib; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate Activity and Toxicity of Tivozanib in mRCC Subjects
To evaluate the activity and toxicity of tivozanib in mRCC study participants who failed at least 1 prior VEGF-targeted therapy.
Measured: 2 years
Secondary outcomes (2)
Evaluate Activity and Toxicity of adding Gemcitabine in Subjects who Progress on Tivozanib
To evaluate the activity and toxicity upon adding gemcitabine in study participants who progress on tivozanib
Measured: 2 years
Investigate Potential Biomarkers of Resistance to Tivozanib
To investigate potential biomarkers of resistance to tivozanib from metastatic RCC lesions and plasma at different time points.
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 posted17 Apr 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: Sponsor Aveo has withdrawn support for this trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Toni Choueiri, MD, Dana-Farber Cancer Institute
- Investigators
- Toni Choueiri, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834183
- Sponsor's protocol ID
- 13-084
- Status last verified
- Jun 2013
- First submitted
- 12 Apr 2013
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II and Biomarker Study of Tivozanib With Gemcitabine Addition Upon Progression in Patients With Metastatic Refractory Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01834183
- Acronym / sponsor ID
- 13-084
- Conditions
- Renal Cell Carcinoma
- Keywords
- Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor Aveo has withdrawn support for this trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Apr 2013 (estimated)
- Results
- Not posted in the source record
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 a PHase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether the combination of drugs works in treating a specific cancer. "Investigational" means that the combination of drugs is being studied. It also means that the FDA has not yet approved these drugs or combination of drugs for use in participants, including people with your type of cancer.
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. This drug has been used in other research studies and information from those other research studies suggests that this drug may help to slow the growth of cancer cells.
Gemcitabine is a chemotherapy drug that is approved by the FDA for the treatment of pancreatic cancer and several other cancers. It is not approved for the treatment of renal cell carcinoma. Previous research suggests combining gemcitabine with tivozanib may have some effectiveness in treating metastatic renal cell carcinoma.
The purpose of this research study is to determine the effectiveness of tivozanib as a treatment for renal cell carcinoma. The purpose of this research study is to also determine if the combination of tivozanib and gemcitabine is effective in treating your type of cancer if your cancer becomes unresponsive or gets worse with tivozanib as treatment alone. The safety of the combination of tivozanib and gemcitabine will also wbe studied.
Another goal of this research study is to learn more about how tivozanib alone and the combination of tivozanib and gemcitabine may work to treat renal cell carcinoma. During the research study we will perform blood tests to measure the level of substances in the blood such as proteins (biomarkers) that may predict who will respond to treatment with tivozanib and gemcitabine.
Detailed description
If you agree to participate in this study you will be asked to undergo some screening tests and procedures to confirm that you are eligible. 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 you do not take part in this study. If you have had some of these tests and procedures recently, they may or may not need to be repeated. The screening process will include the following: medical history, physical examination, measurement of vital signs, performance status assessment, electrocardiogram (EKG), echocardiogram (ECHO), CT or MRI, routine blood tests, urine sample, blood pregnancy test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.
This study is broken into two segments. In the first segment, you will receive tivozanib alone. Every 28 days in this study is called a study "cycle". You will come to clinic once every 28 days (once a month), on 'day 1' of each 28 day cycle.
Tivozanib is a pill that you take by mouth. You will take it once per day, in the morning, with a glass of water, with or without food. You will take tivozanib days 1-21 (the first three weeks) of each 28 day treatment cycle. You will be given a Study Drug Administration Diary to keep a brief record of the date and time when you take your dose of tivozanib. The study staff will explain to you how to complete your diary. This will be reviewed during yur visits by your doctor or a member of the study staff. This diary will be collected at your visit at the end of each cycle, and a new one will be given to you at the start of the next cycle. You will also have a pre-dose research blood draw (approximately 8 teaspoons of blood will be drawn) prior to your first dose of tivozanib, and after your first cycle of tivozanib. Your samples will not have personal information about you (such as your name and address) on them.
On Day 1 of every cycle you will have: a medical history, physical exam, measurement of your vital signs, performance status assessment, routine blood tests to monitor your health, urine sample. Every other cycle (prior to cycle 3, 5, 7 etc). you will have a CT or MRI scan, EKG, ECHO.
If your cancer gets worse while receiving tivozanib alone you may be eligible to participate in segment 2 of the study and receive tivozanib in combination with gemcitabine. You will come to the clinic on days 1 and 8 of each 28 day cycle.
Gemcitabine will be given through a vein (intravenously, or IV) over a period of 30 minutes at the study clinic. This is called an infusion. You will receive the gemcitabine on days 1 and 8 of each treatment cycle.
You will also have a pre-dose research blood draw (approximately 8 teaspoons of blood will be drawn) prior to your first cycle of tivozanib and gemcitabine in combination, after your first 28 days cycle of tivozanib and gemcitabine in combination, and if your cancer gets worse while receiving tivozanib and gemcitabine in combination. Your samples will not have personal information about you (such as your name and address) on them.
If your doctor determines it is safe for you to have a biopsy, you will undergo a fresh tumor biopsy at the following time points: Prior to receiving your first 28 day cycle of tivozanib and gemcitabine in combination; and after two 28 day cycles (roughly 2 months) of receiving tivozanib and gemcitabine in combination.
On Days 1 and 8 and at the end of study treatment you will undergo a medical history, physical examination, measurement of vital signs, performance status assessment, routine blood tests and a urine sample.
If an unexpected or unwanted event happens during the study, you may be asked to have some extra tests or measurements. Some of the tests or measurements done during the study may have to be repeated if the results are not usable or are abnormal. If additional visits are required during your participation in this study, your study doctor may perform the following procedures and evaluations: medical history, vital sign measurements, physical exam, ECG, performance status, blood and urine tests and/or a review of your study drug administration diary.
We would like to keep track of your medical condition indefinitely. If we do not hear from you, we would like to do this by calling no more than every three months to see how you are doing. Keeping in touch with you and checking your condition helps us look at the long-term effects of the research.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tivozanib/Gemcitabine | Experimental | Drug: Tivozanib, Drug: GemcitabineSegment 1: Tivozanib, taken orally days 1-21 of each 28 day cycle. Segment 2: Tivozanib, taken orally days 1-21 of each 28 day cycle. Gemcitabine, taken intravenously, Days 1 and 8 of each 28 day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed renal cell carcinoma that is metastatic
- Failed at least one prior VEGF-targeted therapy
- Prior immunotherapy and mTOR inhibitors are allowed
- Evidence of unidimensionally measurable disease based on RECIST 1.1 criteria, with at least 1 measurable lesion
- Willing to use adequate contraceptive measures while on study and for 30 days after the lst dose of study drug
Key exclusion criteria (14 listed)
- Prior gemcitabine or tivozanib
- Anticipated need for major surgical procedure during the course of the study
- Pregnant or breastfeeding
- Known prior history of hypertensive crisis or hypertensive encephalopathy
- Primary central nervous system malignancies or leptomeningeal metastases
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: AV-951 | Drug | Tivozanib/Gemcitabine |
| Gemcitabine | Drug | Tivozanib/Gemcitabine |
Primary outcome
Evaluate Activity and Toxicity of Tivozanib in mRCC Subjects
Time frame: 2 years
To evaluate the activity and toxicity of tivozanib in mRCC study participants who failed at least 1 prior VEGF-targeted therapy.
2 secondary outcomes
Evaluate Activity and Toxicity of adding Gemcitabine in Subjects who Progress on Tivozanib
Time frame: 2 years
Investigate Potential Biomarkers of Resistance to Tivozanib
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
Toni Choueiri, MD principal investigator
Dana-Farber Cancer Institute
4 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 Tivozanib and Gemcitabine in people with Renal Cell Carcinoma, run by Dana-Farber Cancer Institute at 4 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 8 inclusion and 14 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: withdrawn, as of the sponsor's last update on 19 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluate Activity and Toxicity of Tivozanib in mRCC Subjects (time frame: 2 years). 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 19 Jun 2013.