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NCT01573780 · ClinicalTrials.gov registry record · Phase 1

Gemcitabine Hydrochloride and Smac Mimetic TL32711 in Treating Patients With Advanced Solid Tumors

A Phase 1 study, sponsored by Roswell Park Cancer Institute.

Terminated
Registry status
Phase 1
Development phase
21
Enrollment target

NCT01573780: Clinical Trial Phase 1 study, sponsored by Roswell Park Cancer Institute.

NCT01573780 is a Phase 1 study that was terminated before completion, run by Roswell Park Cancer Institute. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01573780, a Phase 1 study, was terminated before completion, sponsored by Roswell Park Cancer Institute.

TERMINATED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

The purpose of this study is to determine the dose of smac mimetic TL32711 that is safe and tolerated when given with gemcitabine hydrochloride to patients with advanced cancer

Primary Outcome

Defined as the highest dose level at which less than 2 of 6 patients experience study treatment-related dose-limiting toxicity. Summarized with frequencies and descriptive measures, and tabulated according to body system, severity and relation to treatment.

Interventions

  • OTHER laboratory biomarker analysis
  • PROCEDURE biopsy
  • OTHER pharmacological study
  • DRUG gemcitabine hydrochloride
  • DRUG Smac mimetic TL32711

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2012-04
Phase Phase 1
Roswell Park Cancer Institute

365 total trials

Why NCT01573780 stopped before completion

NCT01573780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

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

NCT01573780 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01573780 about?

NCT01573780 is a clinical study titled "Gemcitabine Hydrochloride and Smac Mimetic TL32711 in Treating Patients With Advanced Solid Tumors". The purpose of this study is to determine the dose of smac mimetic TL32711 that is safe and tolerated when given with gemcitabine hydrochloride to patients with advanced cancer

What is the current status of trial NCT01573780?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2012-04.

What interventions are being tested in trial NCT01573780?

The interventions under investigation include: laboratory biomarker analysis (OTHER), biopsy (PROCEDURE), pharmacological study (OTHER), gemcitabine hydrochloride (DRUG), Smac mimetic TL32711 (DRUG).

Who is sponsoring clinical trial NCT01573780?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01573780's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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 NCT01573780, the US trial registry maintained by the National Library of Medicine. NCT01573780 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.