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NCT02048371 · ClinicalTrials.gov registry record · Phase 2

SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes

A Phase 2 study, sponsored by Sarcoma Alliance for Research through Collaboration.

Completed
Registry status
Phase 2
Development phase
131
Enrollment target

NCT02048371: Completed Phase 2 study, sponsored by Sarcoma Alliance for Research through Collaboration.

NCT02048371 is a Phase 2 study that has completed, run by Sarcoma Alliance for Research through Collaboration. The registered enrollment target is 131 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02048371, a Phase 2 study, has completed, sponsored by Sarcoma Alliance for Research through Collaboration.

COMPLETED
Registry status
Phase 2
Development phase
131 participants
Enrollment target

Study Summary

Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazopanib in soft tissue sarcomas, and evidence of activity of sorafenib in osteogenic sarcoma and possibly Ewing/Ewing-like sarcoma, there is precedent to examine SMOKIs (small molecule oral kinase inhibitors) such as regorafenib in sarcomas other than GIST. It is also recognized that SMOKIs (small molecule oral kinase inhibitors)such as regorafenib, sorafenib, pazopanib, and sunitinib have overlapping panels of kinases that are inhibited simultaneously. While not equivalent, most of these SMOKIs (small molecule oral kinase inhibitors) block vascular endothelial growth factor and platelet derived growth factors receptors (VEGFRs and PDGFRs), speaking to a common mechanism of action of several of these agents.

Primary Outcome

The progression-free survival is the length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. Cohort A (liposarcoma) and Cohort B (osteosarcoma). PFS will be evaluated according to RECIST (Response Evaluation Criteria In Solid Tumors) 1.1, where a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Interventions

  • DRUG Placebo
  • DRUG Regorafenib

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2014-07
Est. Completion 2022-05
Phase Phase 2

What the finished NCT02048371 record still lists

NCT02048371 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02048371 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02048371 about?

NCT02048371 is a clinical study titled "SARC024: A Blanket Protocol to Study Oral Regorafenib in Patients With Selected Sarcoma Subtypes". Although regorafenib was approved for use in patients who had progressive GIST despite imatinib and/or sunitinib on the basis of phase II and phase III data, it has not been examined in a systematic fashion in patients with other forms of sarcoma. Given the activity of sorafenib, sunitinib and pazo...

What is the current status of trial NCT02048371?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2014-07. Estimated completion is 2022-05.

What interventions are being tested in trial NCT02048371?

The interventions under investigation include: Placebo (DRUG), Regorafenib (DRUG).

Who is sponsoring clinical trial NCT02048371?

This trial is sponsored by Sarcoma Alliance for Research through Collaboration, which has 20 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02048371's enrollment target sits among peer trials

131 541st of 2000 higher than 1,458 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 NCT02048371, the US trial registry maintained by the National Library of Medicine. NCT02048371 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.