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NCT01335204 · ClinicalTrials.gov registry record · Phase 1

Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer

A Phase 1 study, sponsored by Medical University of South Carolina.

Terminated
Registry status
Phase 1
Development phase
4
Enrollment target

NCT01335204: Clinical Trial Phase 1 study, sponsored by Medical University of South Carolina.

NCT01335204 is a Phase 1 study that was terminated before completion, run by Medical University of South Carolina. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01335204, a Phase 1 study, was terminated before completion, sponsored by Medical University of South Carolina.

TERMINATED
Registry status
Phase 1
Development phase
4 participants
Enrollment target

Study Summary

This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research. This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy. Patients must meet the study eligibility criteria and must be competent to give informed consent.

Primary Outcome

The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.

Interventions

  • DRUG Cabazitaxel plus bavituximab

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2011-06
Est. Completion 2013-03
Phase Phase 1

Why NCT01335204 stopped before completion

NCT01335204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Cabazitaxel plus bavituximab is the first listed.

NCT01335204 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01335204 about?

NCT01335204 is a clinical study titled "Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer". This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the ...

What is the current status of trial NCT01335204?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2011-06. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01335204?

The interventions under investigation include: Cabazitaxel plus bavituximab (DRUG).

Who is sponsoring clinical trial NCT01335204?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01335204's enrollment target sits among peer trials

4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01335204, the US trial registry maintained by the National Library of Medicine. NCT01335204 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.