NCT01369433 - A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols | Biotech Hunter

Enrollment

225

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

June 30, 2015

Study Completion Date

October 31, 2015

Conditions

Solid Tumors

Interventions

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.

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.

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.

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.

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.

DRUG

Tivo

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

Trial Locations (49)

19019

Philadelphia

20850

Associates in Oncology/Hematology, Rockville

27514

Chapel Hill

33612

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

33905

Florida Cancer Specialists, Fort Myers

37203

Sarah Cannon Research Institute (SCRI), Nashville

38801

Tupelo

43004

Columbus

46107

Beech Grove

47905

Horizon Oncology Research, Inc., Lafayette

49501

Grand Rapids

57217

Wichita

68114

Nebraska Methodist Hospital, Omaha

70006

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

70801

Medical Oncology LLC, Baton Rouge

73117

The OU Cancer Institute, Oklahoma City

73301

Austin

75001

Dallas

78336

Coastal Bend Cancer Center, Corpus Christi

80010

Aurora

85258

Translational Genomics Research Institute (TGEN), Scottsdale

88901

Las Vegas

90024

Institute of Urologic Oncology, Los Angeles

94305

Stanford University, Stanford

98402

Tacoma

02115

Dana Farber Cancer Institute, Boston

03748

Lebanon

Unknown

Hamilton

Toronto

Montreal

AVEO Investigational Site, Madurai

AVEO Investigational Site, Mumbai

Rotterdam

AVEO Investigational Site, Krasnodar

AVEO Investigational Site - Moscow 1, Moscow

AVEO Investigational Site - Moscow 2, Moscow

AVEO Investigational Site - Moscow 3, Moscow

AVEO Investigational Site - Moscow 4, Moscow

AVEO Investigational Site - Moscow 5, Moscow

AVEO Investigational Site, Obninsk

AVEO Investigational Site, Rostov

AVEO Investigational Site, Saint Petersburg

Stavropol

AVEO Investigational Site, Ufa

AVEO Investigational Site, Dnipropetrovsk

AVEO Investigational Site, Donetsk

AVEO Investigational Site, Kharkiv

AVEO Investigational Site, Lviv

AVEO Investigational Site, Zaporizhya