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

NCT01369433 | Terminated Results

• 1 other identifier: AV-951-09-901
• Study Type: interventional
• Target: 225
• Locations: 6 countries
• Sites: 49

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).

Conditions

Solid Tumors

Keywords

tivozanib

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Months

Study Arms (6)

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).

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.

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.

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).

Drug: Tivozanib (AV-951)

tivozanib + capecitabine

EXPERIMENTAL

After Ph 1b study tolerable to Tivo + Xeloda®

Drug: Tivozanib + capecitabine

tivozanib Advanced RCC

EXPERIMENTAL

After biomarker study tolerable to Tivo

Drug: Tivo

Interventions

Tivozanib + paclitaxel 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.

Also known as: Tivo (AV-951) + paclitaxel

tivozanib + paclitaxel

Tivozanib + temsirolimus 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.

Also known as: Tivo (AV-951) + temsirolimus

tivozanib + temsirolimus

Tivozanib DRUG

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

Also known as: Tivo (AV951)

tivozanib renal cell carcinoma (RCC)

Tivozanib (AV-951) DRUG

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

Also known as: Tivo, (AV-951)

tivozanib solid tumors - QTC

Tivozanib + capecitabine 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.

Also known as: Tivo, (AV-951) + capecitabine

tivozanib + capecitabine

Tivo DRUG

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

Also known as: Tivo, (AV-951)

tivozanib Advanced RCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \> 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)
• 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

Sponsors & Collaborators

• AVEO Pharmaceuticals, Inc.: lead

Study Sites (49)

Translational Genomics Research Institute (TGEN)

Scottsdale, Arizona, 85258, United States

Location

Institute of Urologic Oncology

Los Angeles, California, 90024, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Unknown Facility

Aurora, Colorado, 80010, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33905, United States

Location

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

Tampa, Florida, 33612, United States

Location

Unknown Facility

Beech Grove, Indiana, 46107, United States

Location

Horizon Oncology Research, Inc.

Lafayette, Indiana, 47905, United States

Location

Unknown Facility

Wichita, Kansas, 57217, United States

Location

Medical Oncology LLC

Baton Rouge, Louisiana, 70801, United States

Location

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

Metairie, Louisiana, 70006, United States

Location

Associates in Oncology/Hematology

Rockville, Maryland, 20850, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Unknown Facility

Grand Rapids, Michigan, 49501, United States

Location

Unknown Facility

Tupelo, Mississippi, 38801, United States

Location

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

Location

Unknown Facility

Las Vegas, Nevada, 88901, United States

Location

Unknown Facility

Lebanon, New Hampshire, 03748, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27514, United States

Location

Unknown Facility

Columbus, Ohio, 43004, United States

Location

The OU Cancer Institute

Oklahoma City, Oklahoma, 73117, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19019, United States

Location

Sarah Cannon Research Institute (SCRI)

Nashville, Tennessee, 37203, United States

Location

Unknown Facility

Austin, Texas, 73301, United States

Location

Coastal Bend Cancer Center

Corpus Christi, Texas, 78336, United States

Location

Unknown Facility

Dallas, Texas, 75001, United States

Location

Unknown Facility

Tacoma, Washington, 98402, United States

Location

Unknown Facility

Hamilton, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

AVEO Investigational Site

Madurai, India

Location

AVEO Investigational Site

Mumbai, India

Location

Unknown Facility

Rotterdam, Netherlands

Location

AVEO Investigational Site

Krasnodar, Russia

Location

AVEO Investigational Site - Moscow 1

Moscow, Russia

Location

AVEO Investigational Site - Moscow 2

Moscow, Russia

Location

AVEO Investigational Site - Moscow 3

Moscow, Russia

Location

AVEO Investigational Site - Moscow 4

Moscow, Russia

Location

AVEO Investigational Site - Moscow 5

Moscow, Russia

Location

AVEO Investigational Site

Obninsk, Russia

Location

AVEO Investigational Site

Rostov, Russia

Location

AVEO Investigational Site

Saint Petersburg, Russia

Location

Unknown Facility

Stavropol, Russia

Location

AVEO Investigational Site

Ufa, Russia

Location

AVEO Investigational Site

Dnipropetrovsk, Ukraine

Location

AVEO Investigational Site

Donetsk, Ukraine

Location

AVEO Investigational Site

Kharkiv, Ukraine

Location

AVEO Investigational Site

Lviv, Ukraine

Location

AVEO Investigational Site

Zaporizhya, Ukraine

Location

Related Links

• Aveo Pharmaceuticals, Inc. official web page

MeSH Terms

Interventions

tivozanib; Paclitaxel; temsirolimus; Capecitabine

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Chief Medical Officer
• Organization: AVEO Pharmaceuticals, Inc.

Clinical@aveooncology.com

857-400-0101

Study Officials

• Anna Berkenblit, MD

  AVEO Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: June 9, 2011
• Study Start: June 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 1, 2020
• Results First Posted: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (27); RU (11); CA (3); NL (1); UA (5); IN (2)