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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01369433
• Other study ID #: AV-951-09-901
• Status: Terminated
• Phase: N/A
• Start date: June 2010
• Est. completion date: October 2015

Study information

• Verified date: August 2020
• Source: AVEO Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 225
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumors

Intervention

Drug:
• 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.
• 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.
• Tivozanib
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)
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
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.
• Tivo
Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment.

Locations

Country	Name	City	State
India	AVEO Investigational Site	Madurai
India	AVEO Investigational Site	Mumbai
Russian Federation	AVEO Investigational Site	Krasnodar
Russian Federation	AVEO Investigational Site - Moscow 1	Moscow
Russian Federation	AVEO Investigational Site - Moscow 2	Moscow
Russian Federation	AVEO Investigational Site - Moscow 3	Moscow
Russian Federation	AVEO Investigational Site - Moscow 4	Moscow
Russian Federation	AVEO Investigational Site - Moscow 5	Moscow
Russian Federation	AVEO Investigational Site	Obninsk
Russian Federation	AVEO Investigational Site	Rostov
Russian Federation	AVEO Investigational Site	Saint Petersburg
Russian Federation	AVEO Investigational Site	Ufa
Ukraine	AVEO Investigational Site	Dnipropetrovsk
Ukraine	AVEO Investigational Site	Donetsk
Ukraine	AVEO Investigational Site	Kharkiv
Ukraine	AVEO Investigational Site	Lviv
Ukraine	AVEO Investigational Site	Zaporizhya
United States	Medical Oncology LLC	Baton Rouge	Louisiana
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Coastal Bend Cancer Center	Corpus Christi	Texas
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Horizon Oncology Research, Inc.	Lafayette	Indiana
United States	Institute of Urologic Oncology	Los Angeles	California
United States	Jayne Gurtler MD, Laura Brinz MD, Angelo Russo MD and Janet Burroff MD APMC	Metairie	Louisiana
United States	Sarah Cannon Research Institute (SCRI)	Nashville	Tennessee
United States	The OU Cancer Institute	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Associates in Oncology/Hematology	Rockville	Maryland
United States	Translational Genomics Research Institute (TGEN)	Scottsdale	Arizona
United States	Stanford University	Stanford	California
United States	H. Lee Moffitt Cancer Center & Research Institute Hospital, Inc	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AVEO Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  India,  Netherlands,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Aveo Pharmaceuticals, Inc. official web page