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NCT01016015 · ClinicalTrials.gov registry record · Phase 2

Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
178
Enrollment target

NCT01016015: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT01016015 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 178 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01016015, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
178 participants
Enrollment target

Study Summary

This phase II trial studies how well temsirolimus and cixutumumab works in treating patients with locally advanced, metastatic, or recurrent soft tissue sarcoma or bone sarcoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as cixutumumab, can block tumor growth by blocking the ability of tumor cells to grow and spread. Giving temsirolimus with cixutumumab may be an effective treatment for soft tissue or bone sarcoma.

Primary Outcome

From study entry until recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurement recorded on study), death or date of last contact, assessed at 12 weeks

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Temsirolimus
  • BIOLOGICAL Cixutumumab

Trial Details

FieldValue
Enrollment Target 178 participants
Start Date 2009-11
Est. Completion 2014-07
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT01016015 record still lists

NCT01016015 is an interventional study that assigns participants to a tested intervention. The registered 178 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (34% higher).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01016015 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01016015 about?

NCT01016015 is a clinical study titled "Temsirolimus and Cixutumumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Soft Tissue Sarcoma or Bone Sarcoma". This phase II trial studies how well temsirolimus and cixutumumab works in treating patients with locally advanced, metastatic, or recurrent soft tissue sarcoma or bone sarcoma. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibod...

What is the current status of trial NCT01016015?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 178 participants. The study started on 2009-11. Estimated completion is 2014-07.

What interventions are being tested in trial NCT01016015?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Temsirolimus (DRUG), Cixutumumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT01016015?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01016015's enrollment target sits among peer trials

178 391st of 2000 higher than 1,607 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 NCT01016015, the US trial registry maintained by the National Library of Medicine. NCT01016015 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.