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NCT00933426 · ClinicalTrials.gov registry record · Phase 1

Lenalidomide and Paclitaxel in Prostate Cancer

A Phase 1 study, sponsored by M.D. Anderson Cancer Center.

Terminated
Registry status
Phase 1
Development phase
17
Enrollment target

NCT00933426: Clinical Trial Phase 1 study, sponsored by M.D. Anderson Cancer Center.

NCT00933426 is a Phase 1 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00933426, a Phase 1 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.

TERMINATED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostate cancer who have failed treatment with taxanes. The goal of the Phase II part of this clinical research study is to learn if lenalidomide and paclitaxel can help to control prostate cancer. The safety of this combination treatment will be studied in both phases of the study. UPDATE: Study was terminated early due to slow accrual as a Phase I dose escalation study, without progression to Phase II study portion.

Primary Outcome

MTD defined as dose with posterior mean Pr{toxicity} closest to .33 at the end of the trial, provided that it is not terminated early. The CRM will be implemented using fixed toxicity probabilities (p1, p2, p3, p4, p5) = (.05, .20, .33, .45, .60) under the model Pr{toxicity \| dose level j} = {pj}exp(a) , where a follows a normal prior with mean 0 and variance 2. Dose limiting toxicity (DLT) defined as any of the following treatment-related events occurring within two cycles of therapy (i) uncon

Interventions

  • DRUG Paclitaxel
  • DRUG Lenalidomide

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2009-08
Est. Completion 2015-12
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

Why NCT00933426 stopped before completion

NCT00933426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).

The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.

NCT00933426 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00933426 about?

NCT00933426 is a clinical study titled "Lenalidomide and Paclitaxel in Prostate Cancer". The goal of the Phase I part of this clinical research study is to find the highest tolerable dose of Revlimid® (lenalidomide) that can be given in combination with paclitaxel to patients with prostate cancer who have failed treatment with taxanes. The goal of the Phase II part of this clinical res...

What is the current status of trial NCT00933426?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2009-08. Estimated completion is 2015-12.

What interventions are being tested in trial NCT00933426?

The interventions under investigation include: Paclitaxel (DRUG), Lenalidomide (DRUG).

Who is sponsoring clinical trial NCT00933426?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00933426's enrollment target sits among peer trials

17 1785th of 2000 higher than 215 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 NCT00933426, the US trial registry maintained by the National Library of Medicine. NCT00933426 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.