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

NCT ID: NCT01369433

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2015-10-31

Brief 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. 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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tivozanib renal cell carcinoma (RCC)

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).

Group Type: EXPERIMENTAL

Tivozanib

Intervention Type: DRUG

Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off.

tivozanib + temsirolimus

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.

Group Type: EXPERIMENTAL

Tivozanib + temsirolimus

Intervention Type: DRUG

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.

tivozanib + paclitaxel

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.

Group Type: EXPERIMENTAL

Tivozanib + paclitaxel

Intervention Type: DRUG

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 solid tumors - QTC

Subjects who participated in a Phase 1 and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951).

Group Type: EXPERIMENTAL

Tivozanib (AV-951)

Intervention Type: DRUG

Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off.

tivozanib + capecitabine

After Ph 1b study tolerable to Tivo + Xeloda®

Group Type: EXPERIMENTAL

Tivozanib + capecitabine

Intervention Type: DRUG

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.

tivozanib Advanced RCC

After biomarker study tolerable to Tivo

Group Type: EXPERIMENTAL

Tivo

Intervention Type: DRUG

Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment.

Interventions

Tivozanib + 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.

Intervention Type: DRUG

Tivozanib + 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.

Intervention Type: DRUG

Tivozanib

Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off.

Intervention Type: DRUG

Tivozanib (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.

Intervention Type: DRUG

Tivozanib + 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.

Intervention Type: DRUG

Tivo

Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment.

Intervention Type: DRUG

Other Intervention Names

Tivo (AV-951) + paclitaxel; Tivo (AV-951) + temsirolimus; Tivo (AV951); Tivo, (AV-951); Tivo, (AV-951) + capecitabine; Tivo, (AV-951)

Eligibility Criteria

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) 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.)

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 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.

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 testing

10. Inability to comply with protocol requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AVEO Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anna Berkenblit, MD

Role: STUDY_DIRECTOR

AVEO Pharmaceuticals, Inc.

Locations

Translational Genomics Research Institute (TGEN)

Scottsdale, Arizona, United States

Institute of Urologic Oncology

Los Angeles, California, United States

Stanford University

Stanford, California, United States

Aurora, Colorado, United States

Florida Cancer Specialists

Fort Myers, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute Hospital, Inc

Tampa, Florida, United States

Beech Grove, Indiana, United States

Horizon Oncology Research, Inc.

Lafayette, Indiana, United States

Wichita, Kansas, United States

Medical Oncology LLC

Baton Rouge, Louisiana, United States

Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC

Metairie, Louisiana, United States

Associates in Oncology/Hematology

Rockville, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Grand Rapids, Michigan, United States

Tupelo, Mississippi, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Lebanon, New Hampshire, United States

Chapel Hill, North Carolina, United States

Columbus, Ohio, United States

The OU Cancer Institute

Oklahoma City, Oklahoma, United States

Philadelphia, Pennsylvania, United States

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, United States

Austin, Texas, United States

Coastal Bend Cancer Center

Corpus Christi, Texas, United States

Dallas, Texas, United States

Tacoma, Washington, United States

Hamilton, Ontario, Canada

Toronto, Ontario, Canada

Montreal, Quebec, Canada

AVEO Investigational Site

Madurai, , India

AVEO Investigational Site

Mumbai, , India

Rotterdam, , Netherlands

AVEO Investigational Site

Krasnodar, , Russia

AVEO Investigational Site - Moscow 1

Moscow, , Russia

AVEO Investigational Site - Moscow 2

Moscow, , Russia

AVEO Investigational Site - Moscow 3

Moscow, , Russia

AVEO Investigational Site - Moscow 4

Moscow, , Russia

AVEO Investigational Site - Moscow 5

Moscow, , Russia

AVEO Investigational Site

Obninsk, , Russia

AVEO Investigational Site

Rostov, , Russia

AVEO Investigational Site

Saint Petersburg, , Russia

Stavropol, , Russia

AVEO Investigational Site

Ufa, , Russia

AVEO Investigational Site

Dnipropetrovsk, , Ukraine

AVEO Investigational Site

Donetsk, , Ukraine

AVEO Investigational Site

Kharkiv, , Ukraine

AVEO Investigational Site

Lviv, , Ukraine

AVEO Investigational Site

Zaporizhya, , Ukraine

Countries

United States; Canada; India; Netherlands; Russia; Ukraine

Related Links

http://www.aveooncology.com

Aveo Pharmaceuticals, Inc. official web page

Other Identifiers

AV-951-09-901

Identifier Type: -

Identifier Source: org_study_id