Clinical trial NCT01369433: A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols
Official title: A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Solid Tumors
Keywords: tivozanib
Lead sponsor: AVEO Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Subjects With Adverse Events (AEs) and Serious AEs
timeFrame: 24 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Translational Genomics Research Institute (TGEN)
state: Arizona
city: Los Angeles
country: United States
facility: Institute of Urologic Oncology
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
state: Colorado
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center & Research Institute Hospital, Inc
state: Florida
city: Beech Grove
country: United States
state: Indiana
city: Lafayette
country: United States
facility: Horizon Oncology Research, Inc.
state: Indiana
city: Wichita
country: United States
state: Kansas
city: Baton Rouge
country: United States
facility: Medical Oncology LLC
state: Louisiana
city: Metairie
country: United States
facility: Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC
state: Louisiana
city: Rockville
country: United States
facility: Associates in Oncology/Hematology
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Grand Rapids
country: United States
state: Michigan
city: Tupelo
country: United States
state: Mississippi
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Lebanon
country: United States
state: New Hampshire
city: Chapel Hill
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
facility: The OU Cancer Institute
state: Oklahoma
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute (SCRI)
state: Tennessee
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
facility: Coastal Bend Cancer Center
state: Texas
city: Dallas
country: United States
state: Texas
city: Tacoma
country: United States
state: Washington
city: Hamilton
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Madurai
country: India
facility: AVEO Investigational Site
city: Mumbai
country: India
facility: AVEO Investigational Site
city: Rotterdam
country: Netherlands
city: Krasnodar
country: Russian Federation
facility: AVEO Investigational Site
city: Moscow
country: Russian Federation
facility: AVEO Investigational Site - Moscow 1
city: Moscow
country: Russian Federation
facility: AVEO Investigational Site - Moscow 2
city: Moscow
country: Russian Federation
facility: AVEO Investigational Site - Moscow 3
city: Moscow
country: Russian Federation
facility: AVEO Investigational Site - Moscow 4
city: Moscow
country: Russian Federation
facility: AVEO Investigational Site - Moscow 5
city: Obninsk
country: Russian Federation
facility: AVEO Investigational Site
city: Rostov
country: Russian Federation
facility: AVEO Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: AVEO Investigational Site
city: Stavropol'
country: Russian Federation
city: Ufa
country: Russian Federation
facility: AVEO Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: AVEO Investigational Site
city: Donetsk
country: Ukraine
facility: AVEO Investigational Site
city: Kharkiv
country: Ukraine
facility: AVEO Investigational Site
city: Lviv
country: Ukraine
facility: AVEO Investigational Site
city: Zaporizhya
country: Ukraine
facility: AVEO Investigational Site
Study officials:
affiliation: AVEO Pharmaceuticals, Inc.
name: Anna Berkenblit, MD
role: STUDY_DIRECTOR
References: