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NCT01382706 · ClinicalTrials.gov registry record · Phase 2

Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder

A Phase 2 study, sponsored by University of Southern California.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT01382706: Clinical Trial Phase 2 study, sponsored by University of Southern California.

NCT01382706 is a Phase 2 study that was terminated before completion, run by University of Southern California. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01382706, a Phase 2 study, was terminated before completion, sponsored by University of Southern California.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

This phase II trial studies how well giving docetaxel and lapatinib ditosylate together as second-line therapy works in treating patients with stage IV bladder cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel and lapatinib ditosylate together may kill more tumor cells.

Primary Outcome

Defined as the time period from the start of treatment and documented progression or death without documentation of progression. Summarized with Kaplan-Meier curves. The median will be estimated using a non-parametric method.

Interventions

  • OTHER laboratory biomarker analysis
  • DRUG docetaxel
  • OTHER immunohistochemistry staining method
  • DRUG lapatinib ditosylate
  • GENETIC fluorescence in situ hybridization

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2011-06-13
Est. Completion 2017-12-15
Phase Phase 2
University of Southern California

617 total trials

Why NCT01382706 stopped before completion

NCT01382706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

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

NCT01382706 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01382706 about?

NCT01382706 is a clinical study titled "Docetaxel and Lapatinib in Metastatic Transitional Cell Carcinoma in Bladder". This phase II trial studies how well giving docetaxel and lapatinib ditosylate together as second-line therapy works in treating patients with stage IV bladder cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor ...

What is the current status of trial NCT01382706?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2011-06-13. Estimated completion is 2017-12-15.

What interventions are being tested in trial NCT01382706?

The interventions under investigation include: laboratory biomarker analysis (OTHER), docetaxel (DRUG), immunohistochemistry staining method (OTHER), lapatinib ditosylate (DRUG), fluorescence in situ hybridization (GENETIC).

Who is sponsoring clinical trial NCT01382706?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01382706's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 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 NCT01382706, the US trial registry maintained by the National Library of Medicine. NCT01382706 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.