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NCT02138383 · ClinicalTrials.gov registry record · Phase 1

Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer

A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT02138383: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT02138383 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02138383, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Researchers also want to find out the side effects of these drugs when given together. This study will help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and nab-paclitaxel. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide.

Primary Outcome

To determine the maximally tolerated dose (MTD) of enzalutamide in combination with gemcitabine and nab-paclitaxel in advanced pancreatic cancer.

Interventions

  • DRUG Gemcitabine
  • DRUG Enzalutamide
  • DRUG Nab-paclitaxel

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2014-05-22
Est. Completion 2019-10-07
Phase Phase 1

What the finished NCT02138383 record still lists

NCT02138383 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 3 interventions - of which Gemcitabine is the first listed.

NCT02138383 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02138383 about?

NCT02138383 is a clinical study titled "Enzalutamide in Combination With Gemcitabine and Nab-Paclitaxel for the Treatment of Advanced Pancreatic Cancer". The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer. Researchers also want to find out the side effects of these drugs when given together. This study will help in finding out ...

What is the current status of trial NCT02138383?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2014-05-22. Estimated completion is 2019-10-07.

What interventions are being tested in trial NCT02138383?

The interventions under investigation include: Gemcitabine (DRUG), Enzalutamide (DRUG), Nab-paclitaxel (DRUG).

Who is sponsoring clinical trial NCT02138383?

This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02138383's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 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 NCT02138383, the US trial registry maintained by the National Library of Medicine. NCT02138383 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.