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NCT01369433 · ClinicalTrials.gov registry record · NA
A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols
A NA study, sponsored by AVEO Pharmaceuticals.
- Terminated
- Registry status
- NA
- Development phase
- 225
- Enrollment target
NCT01369433 is a NA study that was terminated before completion, run by AVEO Pharmaceuticals. The registered enrollment target is 225 participants.
The verdict
NCT01369433, a NA study, was terminated before completion, sponsored by AVEO Pharmaceuticals.
- TERMINATED
- Registry status
- NA
- Development phase
- 225 participants
- Enrollment target
Study 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).
Interventions
- DRUG Tivozanib
- DRUG Tivozanib (AV-951)
- DRUG Tivozanib + paclitaxel
- DRUG Tivozanib + temsirolimus
- DRUG Tivozanib + capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 225 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01369433
The ClinicalTrials.gov registry entry for NCT01369433 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 225 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AVEO Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Tivozanib is the first listed.
NCT01369433 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01369433 about?
NCT01369433 is a clinical study titled "A Rollover Protocol to Allow Continued Access to Tivozanib (AV 951) for Subjects Enrolled in Other Tivozanib Protocols". 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)...
What is the current status of trial NCT01369433?
This trial is currently terminated. It is a NA study. The enrollment target is 225 participants. The study started on 2010-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01369433?
The interventions under investigation include: Tivozanib (DRUG), Tivozanib (AV-951) (DRUG), Tivozanib + paclitaxel (DRUG), Tivozanib + temsirolimus (DRUG), Tivozanib + capecitabine (DRUG).
Who is sponsoring clinical trial NCT01369433?
This trial is sponsored by AVEO Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov.
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