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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: Clinical Trial NA study, sponsored by AVEO Pharmaceuticals.

NCT01369433 is a NA study that was terminated before completion, run by AVEO Pharmaceuticals. The registered enrollment target is 225 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.

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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).

Primary Outcome

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.

Interventions

  • DRUG Tivozanib
  • DRUG Tivozanib (AV-951)
  • DRUG Tivozanib + paclitaxel
  • DRUG Tivozanib + temsirolimus
  • DRUG Tivozanib + capecitabine

Trial Details

FieldValue
Enrollment Target 225 participants
Start Date 2010-06
Est. Completion 2015-10
Phase NA
AVEO Pharmaceuticals

27 total trials

Why NCT01369433 stopped before completion

NCT01369433 is an interventional study that assigns participants to a tested intervention. The registered 225 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (84% lower).

The record links to 0 conditions, and to 5 interventions - of which Tivozanib is the first listed.

NCT01369433 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01369433's enrollment target sits among peer trials

225 472nd of 2000 higher than 1,523 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01369433, the US trial registry maintained by the National Library of Medicine. NCT01369433 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.