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NCT01091103 · ClinicalTrials.gov registry record · Phase 2

Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

A Phase 2 study, sponsored by Pfizer.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT01091103: Completed Phase 2 study, sponsored by Pfizer.

NCT01091103 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01091103, a Phase 2 study, has completed, sponsored by Pfizer.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

Primary Outcome

Bone marrow biopsies were performed at the Day 1 visit prior to initiation of enzalutamide administration. Repeat bone marrow biopsies were performed at the Week 9 visit. If a repeat bone marrow was not performed at the Week 9 visit or if a patient discontinued the study before the Week 9 visit, a bone marrow biopsy was obtained at the Safety Follow-up visit. Assessment of intratumoral testosterone was assessed by liquid chromatography mass spectrometry.

Interventions

  • DRUG Enzalutamide

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2010-02-18
Est. Completion 2013-08-31
Phase Phase 2
Pfizer

1,845 total trials

What the finished NCT01091103 record still lists

NCT01091103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).

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

NCT01091103 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01091103 about?

NCT01091103 is a clinical study titled "Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide". This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.

What is the current status of trial NCT01091103?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2010-02-18. Estimated completion is 2013-08-31.

What interventions are being tested in trial NCT01091103?

The interventions under investigation include: Enzalutamide (DRUG).

Who is sponsoring clinical trial NCT01091103?

This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01091103's enrollment target sits among peer trials

60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01091103, the US trial registry maintained by the National Library of Medicine. NCT01091103 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.