Renal Cell CarcinomaPhase 2NCT01297244
A Biomarker Study of Tivozanib in Subjects With Advanced Renal Cell Carcinoma
A Phase 2 study testing Tivozanib in people with Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 25 sites in 2 countries.
Trial summary
This is an open-label, single arm, multicenter study. Subjects will be stratified by histology (clear cell versus non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Jan 2011to Oct 2012
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 year old males or females
- Subjects with unresectable locally recurrent or metastatic renal cell carcinoma (RCC)
- Histologically or cytologically confirmed clear cell renal cell carcinoma (≥ 50% clear cell) or non-clear cell RCC (all histologies)
- Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor.
- Measurable disease per RECIST criteria Version 1.1 (see Appendix A)
- Treatment naïve subjects or subjects who have received no more than one prior systemic treatment (immunotherapy, including interferon-alfa or interleukin-2 based therapy, chemotherapy, hormonal therapy or an investigational agent) for metastatic RCC.
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- Eastern Cooperative Oncology Group performance status of 0 or 1, and life expectancy ≥ 3 months
- If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment
- Willingness to provide archival paraffin embedded tumor tissue, if available.
- Ability to give written informed consent and comply with protocol requirements
Who cannot join
- Any prior vascular endothelial growth factor (VEGF)-directed therapy including VEGF antibody (eg, bevacizumab), VEGF receptor tyrosine kinase inhibitor (eg, sunitinib, sorafenib, axitinib, pazopanib, etc.), VEGF trap (eg, aflibercept), or any other agent or investigational agent targeting the VEGF pathway.
- Any prior therapy with an agent targeting the mechanistic target of rapamycin pathway (eg, temsirolimus, everolimus, etc)
- Primary central nervous system (CNS) malignancies or CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
- Any of the following hematologic abnormalities:
- Hemoglobin < 9.0 g/dL
- Absolute neutrophil count (ANC) < 1500 per mm3
Show all 42Show fewer
- Platelet count < 100,000 per mm3
- International Normalized Ratio >1.5 or partial thromboplastin time >1.5 × upper limit of normal (ULN)
- Any of the following serum chemistry abnormalities:
- Total bilirubin > 1.5 × ULN (or > 2.5 × ULN for subjects with Gilbert's syndrome)
- Aspartate aminotransferase or alanine aminotransferase > 2.5 × ULN (or > 5 × ULN for subjects with liver metastasis)
- Alkaline phosphatase > 2.5 × ULN (or > 5 × ULN for subjects with liver or bone metastasis)
- Creatinine > 2.0 × ULN
- Proteinuria > 3+ by urinalysis or urine dipstick
- Significant cardiovascular disease, including:
- Active clinically symptomatic left ventricular failure.
- Uncontrolled hypertension: Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg on 2 or more antihypertensive medications, 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 (ie, 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
- Non-healing wound, bone fracture, or skin ulcer.
- Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
- Serious/active infection or infection requiring parenteral antibiotics.
- Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
- Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug, including but not limited to:
- Deep vein thrombosis
- Pulmonary embolism
- Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
- Peripheral arterial ischemia > Grade 2 (per CTCAE Version 3.0)
- Significant bleeding disorders within 6 months prior to administration of first dose of study drug, including but not limited to.
- Hematemesis, hematochezia, melena or other gastrointestinal bleeding Grade 2 (per CTCAE Version 3.0)
- Hemoptysis or other pulmonary bleeding Grade 2 (per CTCAE Version 3.0)
- Currently active second primary malignancy, including hematologic malignancies (leukemia, lymphoma, multiple myeloma, etc.), other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast. Subjects are not considered to have a currently active malignancy if they have completed anti-cancer therapy and have been disease free for >2 years.
- Pregnant or lactating females.
- History of genetic or acquired immune suppression disease such as HIV; subjects on immune suppressive therapy for organ transplant.
- Life-threatening illness or organ system dysfunction compromising safety evaluation.
- Requirement for hemodialysis or peritoneal dialysis.
- 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.
- Psychiatric disorder or altered mental status precluding informed consent or protocol-related testing.
- Sexually active pre-menopausal female subjects (and female partners of male subjects) must use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug. All fertile male and female subjects must agree to use a highly effective method of contraception (including their partner). Effective birth control includes:
- intrauterine device plus one barrier method or 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm). (Note: Oral,implantable, or injectable contraceptives
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States20 sites
Texas Oncology-Austin North
Austin, Texas
Medical Oncology, LLC
Baton Rouge, Louisiana
St. Francis Cancer Research Foundation
Beech Grove, Indiana
Dana Farber Cancer Institute
Boston, Massachusetts
Providence Health and Services
Burbank, California
University of North Carolina, Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
Ohio State University
Columbus, Ohio
Coastal Bend Cancer Center
Corpus Christi, Texas, 78404
Texas Oncology-Baylor, Charles A. Sammons Cancer Center
Dallas, Texas
Rocky Mountain Cancer Center
Denver, Colorado
The Jones Clinic
Germantown, Tennessee
Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan
Comprehensive Cancer Centers of Nevada & US Oncology Research
Las Vegas, Nevada
Mary Hitchcock Memorial Hospital, NH
Lebanon, New Hampshire
David Geffen School of Medicine at UCLA
Los Angeles, California
The West Clinic
Memphis, Tennessee
Southern Cancer Center
Mobile, Alabama
Fox Chase Cancer Center
Philadelphia, Pennsylvania
North Mississippi Hematology & Oncology Associates, Ltd.
Tupelo, Mississippi
Cancer Center of Kansas
Wichita, Kansas
Canada5 sites
Juravinski Cancer Center
Hamilton, Ontario
Montreal General Hospital
Montreal, Quebec
Princess Margaret Hospital
Toronto, Ontario
Sunnybrook Odette Cancer Center, Toronto
Toronto, Ontario
BC Cancer Agency Vancouver Centre
Vancouver, British Columbia
About this study
Official title: A Phase 2 and Biomarker Study of Tivozanib in Subjects With Advanced Renal Cell Carcinoma
This is an open-label, single arm, multicenter study. Subjects will be stratified by histology (clear cell versus non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population.
Read the detailed description
This is a Phase 2, open-label, single arm, multi-center, study of orally administered tivozanib to approximately 100 subjects with advanced renal cell carcinoma (RCC). This study is designed to evaluate biomarkers in blood and archived tissue samples, and their correlation with clinical activity and/or treatment-related toxicity in subjects with advanced RCC, and estimate the percentage of tivozanib-treated subjects who are progression-free at 6 months, overall response rate (ORR), progression free survival (PFS), safety and tolerability, and pharmacokinetics (PK). Subjects will be stratified by histology (clear cell vs. non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population.
Study enrollment is anticipated to complete in approximately 9 months. Treatment duration is estimated to last approximately 6 months from the subject's first dose of tivozanib with a follow-up period of 30 days. After 6 months, treatment with tivozanib may continue by participation in a rollover protocol (AV-951-09-901). Maximum duration of subject participation in this Phase 2 study is approximately 8 months.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Tivozanib
- Keywords
- AV-951, Tivozanib, RCC, Biomarkers, Advanced Renal Cell Carcinoma
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TivozanibDrug
Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tivozanib | Experimental | Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. Receives: Drug: Tivozanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers in Blood and Archived Tissue Samples, and Their Correlation With Clinical Activity in Subjects With Advanced Renal Cell Cancer Treated With Tivozanib.
To Evaluate CD68, HIF (hypoxia induced factor) 1/HIF2, VEGF A, VEGF-B, VEGF-C, VEGF-D, HGF (hepatocyte growth factor), CAIX, and PLGF (placental growth factor) levels and a biomarker signature based on transcriptional profiles.
Measured: Cycle 1 day 1, cycle 1 day 15 and cycle 2 day 1.
Biomarkers in Blood and Archived Tissue Samples, and Their Correlation With Treatment-related Toxicity in Subjects With Advanced Renal Cell Cancer Treated With Tivozanib.
To Evaluate biomarkers like VEGF-A, VEGF-B, VEGF-C, VEGF-D, HGF, and PLGF levels, protein expression and metabolite patterns.
Measured: Cycle 1 day 1, cycle 1 day 15 and cycle 2 day 1.
Number of Tivozanib-treated Subjects Who Are Progression-free at 6 Months
Subjects were considered to be progression-free at 6 months if they did not have disease progression or death by Day 182 and if they had an evaluation of confirmed PR, unconfirmed PR, or SD on or after Day 144.
Measured: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib).
Secondary outcomes (3)
Number of Subjects With Objective Response Rate (ORR)
Objective response rate (ORR) is defined as the proportion of evaluable subjects who had a best overall response of complete response (CR) or partial response (PR). Based on RECIST v1.1 for target lesions, CR is the disappearance of all target lesions, reduction in short axis of any pathological lymph nodes (whether target or non-target) to < 10 mm and PR is at least a 30% decrease from baseline in the sum of diameters of target lesions.
Measured: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib).
Kaplan-Meier Estimate of Progression-free Survival (PFS)
PFS is defined as the duration in days from the date of first dose of study drug to the date of first documentation of Progressive Disease (PD) or death (whichever came first), censored at the last tumor assessment documenting the absence of PD prior to the start of further anti-cancer therapy. Based on RECIST v1.1, progressive Disease (PD) is defined as an increase of at least 20%, and an absolute increase of at least 5 mm, in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib).
Number of Subjects With Adverse Events
Subjects were monitored throughout the treatment and 30 day follow-up period for occurrence of adverse events as well as for changes in clinical status, vital signs, and laboratory data.
Safety parameters to be measured/assessed include eligibility assessment, medical history, performance status evaluation, vital signs, physical examination, subjective reports, hematology, serum chemistries, thyroid function tests, coagulation parameters, urinalysis, pregnancy test, and ECG.
Measured: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib) and 30 day follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2012
- Study completionOct 2012
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 Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297244
- Sponsor's protocol ID
- AV-951-10-202
- Status last verified
- Oct 2020
- First submitted
- 14 Feb 2011
- Last updated
- 27 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 and Biomarker Study of Tivozanib in Subjects With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01297244
- Acronym / sponsor ID
- AV-951-10-202
- Conditions
- Renal Cell Carcinoma
- Keywords
- AV-951, Tivozanib, RCC, Biomarkers, Advanced Renal Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 27 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single arm, multicenter study. Subjects will be stratified by histology (clear cell versus non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population.
Detailed description
This is a Phase 2, open-label, single arm, multi-center, study of orally administered tivozanib to approximately 100 subjects with advanced renal cell carcinoma (RCC). This study is designed to evaluate biomarkers in blood and archived tissue samples, and their correlation with clinical activity and/or treatment-related toxicity in subjects with advanced RCC, and estimate the percentage of tivozanib-treated subjects who are progression-free at 6 months, overall response rate (ORR), progression free survival (PFS), safety and tolerability, and pharmacokinetics (PK). Subjects will be stratified by histology (clear cell vs. non-clear cell). Enrollment of non-clear cell subjects will be limited to ≤ 30% of the entire study population.
Study enrollment is anticipated to complete in approximately 9 months. Treatment duration is estimated to last approximately 6 months from the subject's first dose of tivozanib with a follow-up period of 30 days. After 6 months, treatment with tivozanib may continue by participation in a rollover protocol (AV-951-09-901). Maximum duration of subject participation in this Phase 2 study is approximately 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tivozanib | Experimental | Drug: TivozanibSubjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 year old males or females
- Subjects with unresectable locally recurrent or metastatic renal cell carcinoma (RCC)
- Histologically or cytologically confirmed clear cell renal cell carcinoma (≥ 50% clear cell) or non-clear cell RCC (all histologies)
- Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor.
- Measurable disease per RECIST criteria Version 1.1 (see Appendix A)
Key exclusion criteria (42 listed)
- Any prior vascular endothelial growth factor (VEGF)-directed therapy including VEGF antibody (eg, bevacizumab), VEGF receptor tyrosine kinase inhibitor (eg, sunitinib, sorafenib, axitinib, pazopanib, etc.), VEGF trap (eg, aflibercept), or any other agent or investigational agent targeting the VEGF pathway.
- Any prior therapy with an agent targeting the mechanistic target of rapamycin pathway (eg, temsirolimus, everolimus, etc)
- Primary central nervous system (CNS) malignancies or CNS metastases; subjects with previously treated brain metastasis will be allowed if the brain metastasis have been stable without steroid treatment for at least 3 months following prior treatment (radiotherapy or surgery).
- Any of the following hematologic abnormalities:
- Any of the following serum chemistry abnormalities:
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 |
|---|---|---|
| TivozanibSubjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. | Drug | Tivozanib |
Primary outcome
Biomarkers in Blood and Archived Tissue Samples, and Their Correlation With Clinical Activity in Subjects With Advanced Renal Cell Cancer Treated With Tivozanib.
Time frame: Cycle 1 day 1, cycle 1 day 15 and cycle 2 day 1.
To Evaluate CD68, HIF (hypoxia induced factor) 1/HIF2, VEGF A, VEGF-B, VEGF-C, VEGF-D, HGF (hepatocyte growth factor), CAIX, and PLGF (placental growth factor) levels and a biomarker signature based on transcriptional profiles.
Biomarkers in Blood and Archived Tissue Samples, and Their Correlation With Treatment-related Toxicity in Subjects With Advanced Renal Cell Cancer Treated With Tivozanib.
Time frame: Cycle 1 day 1, cycle 1 day 15 and cycle 2 day 1.
To Evaluate biomarkers like VEGF-A, VEGF-B, VEGF-C, VEGF-D, HGF, and PLGF levels, protein expression and metabolite patterns.
Number of Tivozanib-treated Subjects Who Are Progression-free at 6 Months
Time frame: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib).
Subjects were considered to be progression-free at 6 months if they did not have disease progression or death by Day 182 and if they had an evaluation of confirmed PR, unconfirmed PR, or SD on or after Day 144.
3 secondary outcomes
Number of Subjects With Objective Response Rate (ORR)
Time frame: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib).
Kaplan-Meier Estimate of Progression-free Survival (PFS)
Time frame: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib).
Number of Subjects With Adverse Events
Time frame: Throughout the treatment period (approximately 6 months from the subject's first dose of tivozanib) and 30 day follow-up period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
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Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
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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.
The record lists no contact. Use the official record to reach the sponsor.
25 sites in 2 countries: 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 Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 25 sites in 2 countries.
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 10 inclusion and 42 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 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. 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 27 Oct 2020). 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?
Biomarkers in Blood and Archived Tissue Samples, and Their Correlation With Clinical Activity in Subjects With Advanced Renal Cell Cancer Treated With Tivozanib. (time frame: Cycle 1 day 1, cycle 1 day 15 and cycle 2 day 1.). The study lists 3 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 27 Oct 2020.