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NCT01083615 · ClinicalTrials.gov registry record · Phase 3

A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

A Phase 3 study, sponsored by Achieve Life Sciences.

Terminated
Registry status
Phase 3
Development phase
14
Enrollment target

NCT01083615: Clinical Trial Phase 3 study, sponsored by Achieve Life Sciences.

NCT01083615 is a Phase 3 study that was terminated before completion, run by Achieve Life Sciences. The registered enrollment target is 14 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01083615, a Phase 3 study, was terminated before completion, sponsored by Achieve Life Sciences.

TERMINATED
Registry status
Phase 3
Development phase
14 participants
Enrollment target

Study Summary

The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.

Interventions

  • DRUG prednisone
  • DRUG docetaxel
  • DRUG custirsen sodium
  • DRUG cabazitaxel
  • DRUG isotonic, 0.9% sodium chloride

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2010-03
Est. Completion 2013-03
Phase Phase 3
Achieve Life Sciences

17 total trials

Why NCT01083615 stopped before completion

NCT01083615 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

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

NCT01083615 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01083615 about?

NCT01083615 is a clinical study titled "A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)". The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.

What is the current status of trial NCT01083615?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 14 participants. The study started on 2010-03. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01083615?

The interventions under investigation include: prednisone (DRUG), docetaxel (DRUG), custirsen sodium (DRUG), cabazitaxel (DRUG), isotonic, 0.9% sodium chloride (DRUG).

Who is sponsoring clinical trial NCT01083615?

This trial is sponsored by Achieve Life Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01083615's enrollment target sits among peer trials

14 1983rd of 2000 higher than 17 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01083615, the US trial registry maintained by the National Library of Medicine. NCT01083615 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.