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NCT01188499 · ClinicalTrials.gov registry record · Phase 1

Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid Tumors

A Phase 1 study of Cancer, sponsored by TetraLogic Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
176
Enrollment target
7
Study locations

NCT01188499: Completed Phase 1 study of Cancer, sponsored by TetraLogic Pharmaceuticals.

NCT01188499 is a Phase 1 study of Cancer that has completed, run by TetraLogic Pharmaceuticals. The registered enrollment target is 176 participants, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (95% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01188499, a Phase 1 study of Cancer, has completed, sponsored by TetraLogic Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
176 participants
Enrollment target
7
Study locations

Study Summary

This is a dose escalation safety study of birinapant (TL32711) in combination with chemotherapy in subjects with advanced or metastatic solid tumors.

Primary Outcome

Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters

Conditions Studied

Interventions

  • DRUG Birinapant

Study Locations (7)

Pennsylvania

  • University of Pennsylvania Abramson Cancer Center - Philadelphia
  • Fox Chase Cancer Center - Philadelphia

Texas

  • Mary Crowley Cancer Research Center - Dallas
  • South Texas Accelerated Research Therapeutics (START) - San Antonio

Florida

  • Holy Cross Hospital - Fort Lauderdale

Michigan

  • Barbara Ann Karmanos Cancer Center - Detroit

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2010-10
Est. Completion 2014-03
Phase Phase 1
TetraLogic Pharmaceuticals

6 total trials

What the finished NCT01188499 record still lists

NCT01188499 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 3,491-participant average among 615 other Cancer trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Cancer appearing as the primary indexed condition, and to 1 intervention - of which Birinapant is the first listed.

NCT01188499 lists 7 locations in 5 states (Pennsylvania, Texas, Florida).

Frequently Asked Questions

What is clinical trial NCT01188499 about?

NCT01188499 is a clinical study titled "Dose Escalation, Combination Chemotherapy Safety Study of Birinapant (TL32711), in Subjects With Advanced or Metastatic Solid Tumors". This is a dose escalation safety study of birinapant (TL32711) in combination with chemotherapy in subjects with advanced or metastatic solid tumors.

What is the current status of trial NCT01188499?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 176 participants. The study started on 2010-10. Estimated completion is 2014-03.

What conditions does trial NCT01188499 study?

This clinical trial studies the following conditions: Cancer.

What interventions are being tested in trial NCT01188499?

The interventions under investigation include: Birinapant (DRUG).

Who is sponsoring clinical trial NCT01188499?

This trial is sponsored by TetraLogic Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01188499 being conducted?

This trial has 7 study locations across Florida, Michigan, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01188499's enrollment target sits among peer trials

176 249th of 615 higher than 367 of 615 other Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cancer 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 NCT01188499, the US trial registry maintained by the National Library of Medicine. NCT01188499 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.