Advanced Renal Cell CarcinomaPhase 3TIVO-1NCT01030783
A Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma
A Phase 3 study testing tivozanib (AV-951) and Sorafenib in people with Advanced Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 86 sites in 16 countries.
Trial summary
This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Renal Cell Carcinoma
- What is being tested?
- tivozanib (AV-951) and Sorafenib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 517 participants
- Where
- 86 sitesin 16 countries
- Study dates
- Dec 2009to Jun 2013
- Phase
- Phase 3
- 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-years of age.
- Subjects with recurrent or metastatic RCC.
- Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor.
- Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, mixed tumor containing predominantly sarcomatoid cells, and unclassified RCC are excluded).
- Measurable disease per the RECIST criteria Version 1.0.
- 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. Postoperative or adjuvant systemic therapy will not be counted as a prior therapy unless recurrence is detected within 6 months of completion of treatment, in which case it will be counted as a prior therapy for metastatic disease.
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- ECOG 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.
- Ability to give written informed consent and comply with protocol requirements.
Who cannot join
- Any prior 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 mTOR pathway (eg, temsirolimus, everolimus, etc)
- Primary 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 hematologic abnormalities (as noted in the protocol).
- Any serum chemistry abnormalities (as noted in the protocol).
- Significant cardiovascular disease.
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- 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.
- Significant bleeding disorders within 6 months prior to administration of first dose of study drug.
- 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 or sorafenib, major resection of the stomach or small bowel, or gastric bypass procedure.
- Psychiatric disorder or altered mental status precluding informed consent or necessary testing.
- Sexually active pre-menopausal female subjects (and female partners of male subjects) must use adequate contraceptive measures, while on study and for 50 days after the last dose of study drug. Sexually active male subjects must use adequate contraceptive measures, while on study for at least 90 days after the last dose of drug. All fertile male and female subjects and their partners must agree to use a highly effective method of contraception (including their partner). Effective birth control includes (a) IUD plus one barrier method; or (b) 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 may be affected by cytochrome P450 interactions, and are not considered effective for this study.)
Trial locations and contacts
86 sites in 16 countries.
86 sites in 16 countries
Russia19 sites
Site 451
Chelyabinsk, 454087
Site 452
Kazan', 420029
Site 454
Moscow, 105077
Site 453
Moscow, 115478
Site 458
Moscow, 115478
Site 460
Moscow, 115478
Site 461
Moscow, 115478
Site 462
Moscow, 125284
Site 450
Nizhny Novgorod, 603109
Site 456
Obninsk, 249036
Site 467
Omsk, 644013
Site 463
Pyatigorsk, 357500
Site 457
Rostov-on-Don, 344022
Site 466
Saint Petersburg, 193312
Site 465
Saint Petersburg, 198255
Site 459
Ufa, Bashkortostan Republic, 450054
Site 464
Yaroslavi, 150054
Site 455
Yekaterinburg, 620102
Site 468
Yoshkar-Ola, 424037
India12 sites
Site 156
Ahmedabad, Gujarat, 380015
Site 154
Delhi, 110085
Site 157
Hyderabad, Andhra Pradesh, 500004
Site 191
Jaipur, Rajasthan, 302004
Site 155
Jaipur, Rajasthan, 302013
Site 150
Kolkata, West Bengal, 700054
Site 158
Lucknow, Uttar Pradesh, 226003
Site 151
Nashik, Maharashtra, 422005
Site 190
Patna, Bihar, 801505
Site 153
Pune, Maharashtra, 411004
Site 159
Pune, Maharashtra, 411005
Site 152
Vellore, Tamil Nadu, 632004
Ukraine9 sites
Site 491
Chernihiv, 14029
Site 492
Dniproperovsk, 49102
Site 498
Dnipropetrovsk, 49005
Site 493
Donetsk, 83092
Site 496
Donetsk, 83092
Site 490
Ivano-Frankivsk, 76000
Site 494
Kharkiv, 61037
Site 497
Uzhhorod, 88014
Site 495
Zaporizhia, 69600
Poland7 sites
Site 432
Bialystok, 15-027
Site 434
Bydgoszcz, 85-168
Site 431
Gdansk, 80-952
Site 435
Olsztyn, 10-228
Site 433
Poznan, 61-878
Site 430
Warsaw, 02-781
Site 436
Warsaw, 04-141
United States6 sites
Site 187
Dallas, Texas, 75246
Site 180
Gainesville, Florida, 32625
Site 185
Los Angeles, California, 90095
Site 182
Minneapolis, Minnesota, 55455
Site 186
New York, New York, 10065
Site 184
Orlando, Florida, 32806
Bulgaria5 sites
Site 403
Plovdiv, 4004
Site 404
Sofia, 1431
Site 400
Sofia, 1756
Site 401
Varna, 9002
Site 402
Veliko Tarnovo, 5000
Romania5 sites
Site 444
Brasov, 500085
Site 441
Bucharest, 022328
Site 440
Bucharest, 041345
Site 443
Bucharest, 050659
Site 442
Timișoara, 300239
Serbia5 sites
Site 480
Belgrade, 11000
Site 481
Belgrade, 11000
Site 482
Belgrade, 11000
Site 484
Kamenitz, 21204
Site 483
Niš, 18000
Hungary4 sites
Site 423
Budapest, H-1108
Site 421
Kaposvár, H-7400
Site 422
Pécs, H-7624
Site 424
Szombathely, H-9700
Chile3 sites
Site 121
La Reina, Santiago de Chile, 7510009
Site 122
Santiago, 8320000
Site 123
Temuco, 4810469
United Kingdom3 sites
Site 170
Cambridge, CB2 0QQ
Site 173
Ipswich, IP4 5WW
Site 172
Leicester, LE1 5WW
About this study
Official title: A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)
This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.
Read the detailed description
This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.
Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib and stratified by geographic region (North America/Western Europe, Central/Eastern Europe, or rest of the world); number of prior treatments (0 or 1); and number of metastatic sites/organs involved (1 or ≥ 2).
- Conditions
- Advanced Renal Cell Carcinoma
- Being tested
- tivozanib (AV-951), Sorafenib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tivozanib (AV-951)Drug
Tivozanib: 1.5 mg orally once daily. 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.
SorafenibDrug
Sorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| tivozanib (AV-951) | Experimental | Not described Receives: Drug: tivozanib (AV-951) |
| sorafenib | Active comparator | Not described Receives: Drug: Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib
Progression-Free Survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.0 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.
Secondary outcomes (6)
Overall Survival (OS) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Overall survival (OS) is defined as the time from the date of randomization to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the subject is known to be alive. Subjects lacking data beyond randomization will have their survival times censored on the date of randomization.
Measured: Date of randomization to date of death
Objective Response Rate (ORR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Objective response rate (ORR) is defined as the percentage of subjects who have at least a 30% reduction in the sum of diameters per RECIST (Version 1.0).
Measured: Every 8 weeks from date of randomization until disease progression
Duration of Response (DR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Duration of response (DR) is defined as the time from the first documentation of objective tumor response to the first documentation of tumor progression per RECIST 1.0 or to death due to any cause.
Measured: Assessed every 8 weeks from date of randomization until date of progression
Safety and Tolerability of Tivozanib and Sorafenib
Dose reductions and interruptions were allowed for subjects taking tivozanib or sorafenib. Any modification of study drug administration, and the reason for such action, was clearly noted on the subject's eCRF.
Measured: From start of treatment therapy to completion of treatment therapy, an average of 11 months
To Compare Kidney-specific Symptoms and Health Outcome Measurements in Subjects Randomized to Treatment With Tivozanib or Sorafenib
The Disease Related Symptom Scale of the Functional Assessment of Cancer Therapy - Advanced Kidney Cancer Symptom Index (FKSI-DRS) measured kidney specific symptoms on a 0-36 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. The Functional Assessment of Cancer Therapy-General (FACT-G) measured general wellbeing scored on a 0-108 scale, with lower scores corresponding to worse overall QOL and higher scores corresponding to better overall QOL. The European Quality of Life-5 Dimensions (EQ-5D) measured patient health related quality of life scored on a 0-1 scale, with 0 being worse health state and 1 being perfect health state. The European Quality of Life-5 Dimensions Visual Analog Scales (EQ-5D VAS) measured patient health related quality of life on a visual analog scale from 0 to 100, with 0 being the worst and 100 being the best. These scales were self-administered by patients at the start of the visit.
Measured: At Day 1 of each 28 day cycle throughout the course of the study, for an average of 11 months per subject
Pharmacokinetics (Serum Concentrations) of Tivozanib
Samples for tivozanib serum concentrations will be collected at the following time points: Cycle 1, Day 1 (prior to dosing), Cycle 1, Day 15 (prior to dosing), Cycle 2, Day 1 (prior to dosing), and Cycle 2, Day 22-28. The serum concentrations of tivozanib were tabulated for individual subjects and summarized by nominal time using standard descriptive statistics (concentrations presented in ng/mL).
Measured: Cycle 1, Day 1 (prior to dosing), Cycle 1, Day 15 (prior to dosing), Cycle 2, Day 1 (prior to dosing), and Cycle 2, Day 22-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2012
- Study completionJun 2013
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 Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 517 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert J. Motzer, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030783
- Sponsor's protocol ID
- AV-951-09-301
- Acronym
- TIVO-1
- Status last verified
- Oct 2019
- First submitted
- 9 Dec 2009
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
PubMed 37146227
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Controlled, Multi-Center, Open-Label Study to Compare Tivozanib (AV-951) to Sorafenib in Subjects With Advanced Renal Cell Carcinoma (TIVO-1)
- ClinicalTrials.gov ID
- NCT01030783
- Acronym / sponsor ID
- TIVO-1 / AV-951-09-301
- Conditions
- Advanced Renal Cell Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 517 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 Dec 2009 (estimated)
- Results
- Posted 28 Oct 2019
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, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.
Detailed description
This is an open-label, randomized, controlled, multi-national, multi-center, parallel-arm trial comparing tivozanib to sorafenib in subjects with advanced RCC. The study is designed to compare the PFS, OS, ORR, DR, safety and tolerability, and kidney specific symptoms/health outcome measurements of tivozanib and sorafenib.
Subjects will be randomized (1:1) to treatment with tivozanib or sorafenib and stratified by geographic region (North America/Western Europe, Central/Eastern Europe, or rest of the world); number of prior treatments (0 or 1); and number of metastatic sites/organs involved (1 or ≥ 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tivozanib (AV-951) | Experimental | Drug: tivozanib (AV-951) |
| sorafenib | Active comparator | Drug: Sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 18-years of age.
- Subjects with recurrent or metastatic RCC.
- Subjects must have undergone prior nephrectomy (complete or partial) for excision of the primary tumor.
- Histologically or cytologically confirmed RCC with a clear cell component (subjects with pure papillary cell tumor or other non-clear cell histologies, including collecting duct, medullary, chromophobe, mixed tumor containing predominantly sarcomatoid cells, and unclassified RCC are excluded).
- Measurable disease per the RECIST criteria Version 1.0.
Key exclusion criteria (20 listed)
- Any prior 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 mTOR pathway (eg, temsirolimus, everolimus, etc)
- Primary 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 hematologic abnormalities (as noted in the protocol).
- Any serum chemistry abnormalities (as noted in the protocol).
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 |
|---|---|---|
| tivozanib (AV-951)Tivozanib: 1.5 mg orally once daily. 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. | Drug | tivozanib (AV-951) |
| SorafenibSorafenib: 400 mg orally twice daily. Subjects will receive 400 mg (2 x 200 mg tablets) sorafenib twice daily continuously, beginning on Day 1. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks. | Drug | sorafenib |
Primary outcome
Progression-free Survival (PFS) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.
Progression-Free Survival (PFS) is defined as the time from randomization to first documentation of objective tumor progression (progressive disease) or death due to any reasons whichever comes first. Disease progression per RECIST 1.0 criteria is defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
6 secondary outcomes
Overall Survival (OS) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Time frame: Date of randomization to date of death
Objective Response Rate (ORR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Time frame: Every 8 weeks from date of randomization until disease progression
Duration of Response (DR) of Subjects Randomized to Treatment With Tivozanib or Sorafenib
Time frame: Assessed every 8 weeks from date of randomization until date of progression
Safety and Tolerability of Tivozanib and Sorafenib
Time frame: From start of treatment therapy to completion of treatment therapy, an average of 11 months
To Compare Kidney-specific Symptoms and Health Outcome Measurements in Subjects Randomized to Treatment With Tivozanib or Sorafenib
Time frame: At Day 1 of each 28 day cycle throughout the course of the study, for an average of 11 months per subject
Pharmacokinetics (Serum Concentrations) of Tivozanib
Time frame: Cycle 1, Day 1 (prior to dosing), Cycle 1, Day 15 (prior to dosing), Cycle 2, Day 1 (prior to dosing), and Cycle 2, Day 22-28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37146227Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
- Related InfoLink provided by the sponsor.
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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.
Robert J. Motzer, MD principal investigator
Memorial Sloan Kettering Cancer Center
86 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tivozanib (AV-951) and Sorafenib in people with Advanced Renal Cell Carcinoma, run by AVEO Pharmaceuticals, Inc. at 86 sites in 16 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 9 inclusion and 20 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 28 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in Russia, India, Ukraine, Poland, United States and 11 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Oct 2019). 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) of Subjects With Advanced Renal Cell Cancer (RCC) Randomized to Treatment With Tivozanib or Sorafenib (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Disease progression was assessed every 8 weeks.). 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 NCT01030783, 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 28 Oct 2019.