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NCT01168791 · ClinicalTrials.gov registry record · Phase 3

Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma

A Phase 3 study, sponsored by Alaunos Therapeutics.

Completed
Registry status
Phase 3
Development phase
447
Enrollment target

NCT01168791: Completed Phase 3 study, sponsored by Alaunos Therapeutics.

NCT01168791 is a Phase 3 study that has completed, run by Alaunos Therapeutics. The registered enrollment target is 447 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01168791, a Phase 3 study, has completed, sponsored by Alaunos Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
447 participants
Enrollment target

Study Summary

This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).

Interventions

  • DRUG doxorubicin in combination with palifosfamide-tris
  • DRUG doxorubicin in combination with placebo

Trial Details

FieldValue
Enrollment Target 447 participants
Start Date 2010-07
Est. Completion 2013-03
Phase Phase 3
Alaunos Therapeutics

22 total trials

What the finished NCT01168791 record still lists

NCT01168791 is an interventional study that assigns participants to a tested intervention. The registered 447 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 2 interventions - of which doxorubicin in combination with palifosfamide-tris is the first listed.

NCT01168791 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01168791 about?

NCT01168791 is a clinical study titled "Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma". This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma ...

What is the current status of trial NCT01168791?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 447 participants. The study started on 2010-07. Estimated completion is 2013-03.

What interventions are being tested in trial NCT01168791?

The interventions under investigation include: doxorubicin in combination with palifosfamide-tris (DRUG), doxorubicin in combination with placebo (DRUG).

Who is sponsoring clinical trial NCT01168791?

This trial is sponsored by Alaunos Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01168791's enrollment target sits among peer trials

447 864th of 2000 higher than 1,137 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01168791, the US trial registry maintained by the National Library of Medicine. NCT01168791 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.