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NCT01438307 · ClinicalTrials.gov registry record · Phase 2

Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 2
Development phase
28
Enrollment target

NCT01438307: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.

NCT01438307 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01438307, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study Summary

Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at \< 12 months median overall survival. New approaches are needed for second line chemotherapy treatment. Cabazitaxel-XRP6258 has shown increased overall survival in metastatic prostate cancer and it is hopeful it can do the same in advanced NSCLC.

Primary Outcome

The objective response is defined as the percentage of patients that achieve a complete and/or partial response according to The Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1).

Interventions

  • DRUG Cabazitaxel-XRP6258 (3-week cycle)
  • DRUG Cabazitaxel-XRP6258 (5-week cycle)

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2011-09
Est. Completion 2015-09
Phase Phase 2
University of Alabama at Birmingham

1,160 total trials

What the finished NCT01438307 record still lists

NCT01438307 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 2 interventions - of which Cabazitaxel-XRP6258 (3-week cycle) is the first listed.

NCT01438307 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01438307 about?

NCT01438307 is a clinical study titled "Phase II Study of Cabazitaxel-XRP6258 in Advanced Non-Small Cell Lung Cancer". Lung cancer is the leading cause of cancer death worldwide and in the United States. The majority of lung cancers are non-small cell lung cancer (NSCLC). The majority of NSCLC cases are advanced at the time of diagnosis. Chemotherapy has improved overall survival but remains limited at \< 12 months ...

What is the current status of trial NCT01438307?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2011-09. Estimated completion is 2015-09.

What interventions are being tested in trial NCT01438307?

The interventions under investigation include: Cabazitaxel-XRP6258 (3-week cycle) (DRUG), Cabazitaxel-XRP6258 (5-week cycle) (DRUG).

Who is sponsoring clinical trial NCT01438307?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01438307's enrollment target sits among peer trials

28 1677th of 2000 higher than 304 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 NCT01438307, the US trial registry maintained by the National Library of Medicine. NCT01438307 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.