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A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols

18 Years
Open (Enrolling by invite only)
Solid Tumors

Thank you

Trial Information

A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols

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

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.

Inclusion Criteria:

1. 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.

2. If female and of childbearing potential, documentation of negative pregnancy test
prior to enrollment.

3. Ability to give written informed consent.

Exclusion Criteria:

1. > 4 weeks since discontinuation of tivozanib treatment on a previous protocol

2. If female, pregnant or lactating

3. 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) 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.)

4. 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.

5. Newly identified 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.

6. Unhealed wounds (including active peptic ulcers)

7. Serious/active infection or infection requiring parenteral antibiotics

8. Life-threatening illness or organ system dysfunction compromising safety evaluation

9. Psychiatric disorder, altered mental status precluding informed consent or necessary

10. Inability to comply with protocol requirements

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess long-term safety and tolerability of tivozanib in subjects who continue on tivozanib, in accordance with the parent protocol.

Outcome Description:

Patients are assessed for safety and tolerability on Day 1 of each cycle via Adverse Event assessments, Study Drug diary, concomitant medications review, blood pressure, hematology and serum chemistry labs, urinalysis with microscopic test as well as disease assessment completed at end of Cycle 2 and every even numbered cycles. All assessments are made in accordance to the protocol of the parent study in which the patient had participated in before enrolling in the AV-951-09-901 rollover study.

Outcome Time Frame:

24 Months

Safety Issue:


Principal Investigator

Anna Berkenblit, MD

Investigator Role:

Study Director

Investigator Affiliation:

AVEO Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

June 2010

Completion Date:

June 2013

Related Keywords:

  • Solid Tumors
  • tivozanib



Stanford University Stanford, California  94305
Florida Cancer Specialists Fort Myers, Florida  33901
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Associates in Oncology/Hematology Rockville, Maryland  20850
Nebraska Methodist Hospital Omaha, Nebraska  68114
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Dana Farber Cancer Institute Boston, Massachusetts  02115
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Medical Oncology LLC Baton Rouge, Louisiana  70809
Sarah Cannon Research Institute (SCRI) Nashville, Tennessee  37203
Translational Genomics Research Institute (TGen) Scottsdale, Arizona  85258
Horizon Oncology Research, Inc. Lafayette, Indiana  
Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC Metairie, Louisiana  
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H. Lee Moffitt Cancer Center & Research Institute Hospital, Inc Tampa, Florida  33612
The OU Cancer Institute Oklahoma City, Oklahoma  73117