Solid TumorsNCT01369433
A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols
A study testing Tivozanib + paclitaxel, Tivozanib + temsirolimus and Tivozanib in people with Solid Tumors, run by AVEO Pharmaceuticals, Inc. at 49 sites in 6 countries.
Trial summary
Open-label, multi-center, multi-national rollover study to allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols. Eligible subjects will continue to receive tivozanib at the same dose and schedule as per the original (parent) protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Tivozanib + paclitaxel, Tivozanib + temsirolimus and Tivozanib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 49 sitesin 6 countries
- Study dates
- Jun 2010to Oct 2015
- Phase
- Interventional
- 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
- The subject must have received tivozanib while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the parent protocol.
- If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
- Ability to give written informed consent.
Who cannot join
- > 4 weeks since discontinuation of tivozanib treatment on a previous protocol
- If female, pregnant or lactating
- Sexually active male and pre-menopausal female subjects (and their partners) unless they agree to use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug. All fertile male and female subjects (and their partners) must agree to use a highly effective method of contraception. Highly effective birth control includes (a) intrauterine device 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.)
- 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.
- Newly identified central nervous system (CNS) malignancies or documented progression of CNS metastases; subjects will be allowed only if the CNS metastases have been adequately treated with radiotherapy or surgery. For subjects receiving steroid therapy please refer to Section 6.3 for allowed steroid maintenance therapy.
- Unhealed wounds (including active peptic ulcers)
Show all 10Show fewer
- Serious/active infection or infection requiring parenteral antibiotics
- Life-threatening illness or organ system dysfunction compromising safety evaluation
- Psychiatric disorder, altered mental status precluding informed consent or necessary testing
- Inability to comply with protocol requirements
Trial locations and contacts
49 sites in 6 countries.
49 sites in 6 countries
United States27 sites
Study site
Aurora, Colorado, 80010
Study site
Austin, Texas, 73301
Medical Oncology LLC
Baton Rouge, Louisiana, 70801
Study site
Beech Grove, Indiana, 46107
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Study site
Chapel Hill, North Carolina, 27514
Study site
Columbus, Ohio, 43004
Coastal Bend Cancer Center
Corpus Christi, Texas, 78336
Study site
Dallas, Texas, 75001
Florida Cancer Specialists
Fort Myers, Florida, 33905
Study site
Grand Rapids, Michigan, 49501
Horizon Oncology Research, Inc.
Lafayette, Indiana, 47905
Study site
Las Vegas, Nevada, 88901
Study site
Lebanon, New Hampshire, 03748
Institute of Urologic Oncology
Los Angeles, California, 90024
Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC
Metairie, Louisiana, 70006
Sarah Cannon Research Institute (SCRI)
Nashville, Tennessee, 37203
The OU Cancer Institute
Oklahoma City, Oklahoma, 73117
Nebraska Methodist Hospital
Omaha, Nebraska, 68114
Study site
Philadelphia, Pennsylvania, 19019
Associates in Oncology/Hematology
Rockville, Maryland, 20850
Translational Genomics Research Institute (TGEN)
Scottsdale, Arizona, 85258
Stanford University
Stanford, California, 94305
Study site
Tacoma, Washington, 98402
H. Lee Moffitt Cancer Center & Research Institute Hospital, Inc
Tampa, Florida, 33612
Study site
Tupelo, Mississippi, 38801
Study site
Wichita, Kansas, 57217
Russia11 sites
AVEO Investigational Site
Krasnodar
AVEO Investigational Site - Moscow 1
Moscow
AVEO Investigational Site - Moscow 2
Moscow
AVEO Investigational Site - Moscow 3
Moscow
AVEO Investigational Site - Moscow 4
Moscow
AVEO Investigational Site - Moscow 5
Moscow
AVEO Investigational Site
Obninsk
AVEO Investigational Site
Rostov-on-Don
AVEO Investigational Site
Saint Petersburg
Study site
Stavropol
AVEO Investigational Site
Ufa
Ukraine5 sites
AVEO Investigational Site
Dnipropetrovsk
AVEO Investigational Site
Donetsk
AVEO Investigational Site
Kharkiv
AVEO Investigational Site
Lviv
AVEO Investigational Site
Zaporizhya
Canada3 sites
Study site
Hamilton, Ontario
Study site
Montreal, Quebec
Study site
Toronto, Ontario
About this study
Open-label, multi-center, multi-national rollover study to allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols. Eligible subjects will continue to receive tivozanib at the same dose and schedule as per the original (parent) protocol. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the (original) parent protocol. Subjects will be seen by the investigator every 4 weeks (± 5 days). Adverse events and blood pressure will be recorded. At the beginning of Cycle 1 and at the beginning of every odd-numbered cycle (Cycle 3, Cycle 5, etc), clinical laboratory values will be recorded. CT scans to assess disease will be performed at the end of even-numbered cycles (Cycle 2, Cycle 4, etc).
Read the detailed description
This is an open-label multi-center, multi-national rollover protocol to allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols, who are tolerating study drug, and displaying clinical benefit.
Enrollment to this protocol will remain open to subjects who participate in current and future protocols with tivozanib. The end of the study is the last treatment visit of the last subject at the last site. Enrollment in this protocol will continue until tivozanib becomes commercially available in the country where the subject is being treated. If a subject is experiencing clinical benefit from tivozanib when the study is discontinued, the sponsor will make every effort to assist the subject in obtaining commercially available tivozanib.
This rollover protocol will be open to eligible subjects on current and future protocols with tivozanib. The number of subjects who will enroll is dependent upon the number of subjects enrolled in tivozanib protocols that tolerate the drug, display clinical benefits, and are willing to participate.
- Conditions
- Solid Tumors
- Being tested
- Tivozanib + paclitaxel, Tivozanib + temsirolimus, Tivozanib, Tivozanib (AV-951), Tivozanib + capecitabine
- Keywords
- tivozanib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tivozanib + paclitaxelDrug
Also called Tivo (AV-951) + paclitaxel
Subjects will continue to receive 0.5 mg, 1.0 mg, or 1.5 mg of tivozanib once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment. On days when paclitaxel and tivozanib (AV-951) are co-administered, tivozanib will be administered immediately following the end of the paclitaxel infusion. All subjects will continue to receive IV paclitaxel 90 mg/m2, administered over 1 hour once a week for 3 weeks, followed by 1 week off.
Tivozanib + temsirolimusDrug
Also called Tivo (AV-951) + temsirolimus
Subjects will receive 0.5 mg, 1.0 mg or 1.5 mg of tivozanib (AV-951) once daily for 3 weeks, followed by 1 week off. On days when tivozanib (AV-951) and temsirolimus are co-administered, tivozanib (AV-951) will be administered immediately following temsirolimus infusion. Subjects will receive 15 mg or 25 mg temsirolimus IV once weekly.
TivozanibDrug
Also called Tivo (AV951)
Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off.
Tivozanib (AV-951)Drug
Also called Tivo, (AV-951)
Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off.
Tivozanib + capecitabineDrug
Also called Tivo, (AV-951) + capecitabine
Subjects will receive 1.5 mg of tivozanib once daily for 2 weeks beginning on Day 1, followed by 1 week off. Subjects will receive Capecitabine (Xeloda®) 825 mg/m2 or 1000 mg/m² or 1250 mg/m² oral twice daily. Subjects will receive capecitabine twice daily for 2 weeks beginning on Day 1, followed by 1 week off.
TivoDrug
Also called Tivo, (AV-951)
Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment.
| Study group | Role | What they receive |
|---|---|---|
| tivozanib renal cell carcinoma (RCC) | Experimental | Subjects who participated in a Phase 2 monotherapy study in RCC and showed tolerability and clinical benefit will be allowed access to tivozanib (AV-951). Receives: Drug: Tivozanib |
| tivozanib + temsirolimus | Experimental | Subjects who participated in a Phase 1b study and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951) + temsirolimus combination. Receives: Drug: Tivozanib + temsirolimus |
| tivozanib + paclitaxel | Experimental | Subjects who participated in a Phase 1b study and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951) + paclitaxel combination. Receives: Drug: Tivozanib + paclitaxel |
| tivozanib solid tumors - QTC | Experimental | Subjects who participated in a Phase 1 and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951). Receives: Drug: Tivozanib (AV-951) |
| tivozanib + capecitabine | Experimental | After Ph 1b study tolerable to Tivo + Xeloda® Receives: Drug: Tivozanib + capecitabine |
| tivozanib Advanced RCC | Experimental | After biomarker study tolerable to Tivo Receives: Drug: Tivo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Adverse Events (AEs) and Serious AEs
Safety and tolerability will be assessed in accordance to the protocol of the parent study in which the subjects had participated, before enrolling in the AV-951-09-901 rollover study.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionJun 2015
- Study completionOct 2015
Why it stopped: Lack of new studies contributing subjects to this study
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 Solid TumorsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVEO Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anna Berkenblit, MD, Study director, AVEO Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369433
- Sponsor's protocol ID
- AV-951-09-901
- Status last verified
- Aug 2020
- First submitted
- 4 Mar 2010
- Last updated
- 1 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols
- ClinicalTrials.gov ID
- NCT01369433
- Acronym / sponsor ID
- AV-951-09-901
- Conditions
- Solid Tumors
- Keywords
- tivozanib
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of new studies contributing subjects to this study
- Enrolment
- 225 participants (actual)
- Lead sponsor
- AVEO Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 1 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, multi-center, multi-national rollover study to allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols. Eligible subjects will continue to receive tivozanib at the same dose and schedule as per the original (parent) protocol. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the (original) parent protocol. Subjects will be seen by the investigator every 4 weeks (± 5 days). Adverse events and blood pressure will be recorded. At the beginning of Cycle 1 and at the beginning of every odd-numbered cycle (Cycle 3, Cycle 5, etc), clinical laboratory values will be recorded. CT scans to assess disease will be performed at the end of even-numbered cycles (Cycle 2, Cycle 4, etc).
Detailed description
This is an open-label multi-center, multi-national rollover protocol to allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols, who are tolerating study drug, and displaying clinical benefit.
Enrollment to this protocol will remain open to subjects who participate in current and future protocols with tivozanib. The end of the study is the last treatment visit of the last subject at the last site. Enrollment in this protocol will continue until tivozanib becomes commercially available in the country where the subject is being treated. If a subject is experiencing clinical benefit from tivozanib when the study is discontinued, the sponsor will make every effort to assist the subject in obtaining commercially available tivozanib.
This rollover protocol will be open to eligible subjects on current and future protocols with tivozanib. The number of subjects who will enroll is dependent upon the number of subjects enrolled in tivozanib protocols that tolerate the drug, display clinical benefits, and are willing to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| tivozanib renal cell carcinoma (RCC) | Experimental | Drug: TivozanibSubjects who participated in a Phase 2 monotherapy study in RCC and showed tolerability and clinical benefit will be allowed access to tivozanib (AV-951). |
| tivozanib + temsirolimus | Experimental | Drug: Tivozanib + temsirolimusSubjects who participated in a Phase 1b study and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951) + temsirolimus combination. |
| tivozanib + paclitaxel | Experimental | Drug: Tivozanib + paclitaxelSubjects who participated in a Phase 1b study and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951) + paclitaxel combination. |
| tivozanib solid tumors - QTC | Experimental | Drug: Tivozanib (AV-951)Subjects who participated in a Phase 1 and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951). |
| tivozanib + capecitabine | Experimental | Drug: Tivozanib + capecitabineAfter Ph 1b study tolerable to Tivo + Xeloda® |
| tivozanib Advanced RCC | Experimental | Drug: TivoAfter biomarker study tolerable to Tivo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject must have received tivozanib while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the parent protocol.
- If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
- Ability to give written informed consent.
Key exclusion criteria (10 listed)
- > 4 weeks since discontinuation of tivozanib treatment on a previous protocol
- If female, pregnant or lactating
- Sexually active male and pre-menopausal female subjects (and their partners) unless they agree to use adequate contraceptive measures, while on study and for 30 days after the last dose of study drug. All fertile male and female subjects (and their partners) must agree to use a highly effective method of contraception. Highly effective birth control includes (a) intrauterine device 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.)
- 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.
- Newly identified central nervous system (CNS) malignancies or documented progression of CNS metastases; subjects will be allowed only if the CNS metastases have been adequately treated with radiotherapy or surgery. For subjects receiving steroid therapy please refer to Section 6.3 for allowed steroid maintenance therapy.
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 + paclitaxelAlso: Tivo (AV-951) + paclitaxelSubjects will continue to receive 0.5 mg, 1.0 mg, or 1.5 mg of tivozanib once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment. On days when paclitaxel and tivozanib (AV-951) are co-administered, tivozanib will be administered immediately following the end of the paclitaxel infusion. All subjects will continue to receive IV paclitaxel 90 mg/m2, administered over 1 hour once a week for 3 weeks, followed by 1 week off. | Drug | tivozanib + paclitaxel |
| Tivozanib + temsirolimusAlso: Tivo (AV-951) + temsirolimusSubjects will receive 0.5 mg, 1.0 mg or 1.5 mg of tivozanib (AV-951) once daily for 3 weeks, followed by 1 week off. On days when tivozanib (AV-951) and temsirolimus are co-administered, tivozanib (AV-951) will be administered immediately following temsirolimus infusion. Subjects will receive 15 mg or 25 mg temsirolimus IV once weekly. | Drug | tivozanib + temsirolimus |
| TivozanibAlso: Tivo (AV951)Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off. | Drug | tivozanib renal cell carcinoma (RCC) |
| Tivozanib (AV-951)Also: Tivo, (AV-951)Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off. | Drug | tivozanib solid tumors - QTC |
| Tivozanib + capecitabineAlso: Tivo, (AV-951) + capecitabineSubjects will receive 1.5 mg of tivozanib once daily for 2 weeks beginning on Day 1, followed by 1 week off. Subjects will receive Capecitabine (Xeloda®) 825 mg/m2 or 1000 mg/m² or 1250 mg/m² oral twice daily. Subjects will receive capecitabine twice daily for 2 weeks beginning on Day 1, followed by 1 week off. | Drug | tivozanib + capecitabine |
| TivoAlso: Tivo, (AV-951)Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. | Drug | tivozanib Advanced RCC |
Primary outcome
Number of Subjects With Adverse Events (AEs) and Serious AEs
Time frame: 24 Months
Safety and tolerability will be assessed in accordance to the protocol of the parent study in which the subjects had participated, before enrolling in the AV-951-09-901 rollover study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Aveo Pharmaceuticals, Inc. official web pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Anna Berkenblit, MD study director
AVEO Pharmaceuticals, Inc.
49 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tivozanib + paclitaxel, Tivozanib + temsirolimus and Tivozanib in people with Solid Tumors, run by AVEO Pharmaceuticals, Inc. at 49 sites in 6 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 3 inclusion and 10 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Russia, Ukraine, Canada, India and 1 more country. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 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?
Number of Subjects With Adverse Events (AEs) and Serious AEs (time frame: 24 Months). 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 1 Sep 2020.