Clinical trial NCT01369433
Conditions: Solid Tumors
Keywords: tivozanib
Sponsor: AVEO Pharmaceuticals, Inc.
Start date: 2010-06-01; Completion date: 2015-10-01
Enrollment: 225 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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). arm 2: 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. arm 3: 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. arm 4: Subjects who participated in a Phase 1 and showed tolerability and clinical benefit will be allowed continued access to the tivozanib (AV-951). arm 5: After Ph 1b study tolerable to Tivo + Xeloda® arm 6: After biomarker study tolerable to Tivo
Interventions: intervention 1: Tivozanib + paclitaxel intervention 2: Tivozanib + temsirolimus intervention 3: Tivozanib intervention 4: Tivozanib (AV-951) intervention 5: Tivozanib + capecitabine intervention 6: Tivo
Intervention descriptions: intervention 1: 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 2: 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 3: Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off. intervention 4: Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off. intervention 5: 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 6: Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment.

Protocol documents: