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NCT02584309 · ClinicalTrials.gov registry record · Phase 2
Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT02584309: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT02584309 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02584309, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
The purpose of this research study is to look at whether giving a drug called dexrazoxane with standard of care doxorubicin affects the progression of the disease. Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and severity of disease of the heart muscle (which can be caused by doxorubicin). In January 2019 Eli Lilly and Company reported that the results of the Phase 3 study of olaratumab (Lartruvo), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma, did not confirm the clinical benefit of olaratumab in combination with doxorubicin as compared to doxorubicin alone. Therefore olaratumab is being removed from the front line standard of care regimen. Amendment #9 was made to the protocol to reflect these changes to the standard of care treatment.
Primary Outcome
* PFS is defined as the time from on study to the first occurrence of progression or death, whichever occurs first. * If no event exists, the PFS will be censored at the last follow-up. * Progressive disease - At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at leas
Interventions
- DRUG Doxorubicin
- DRUG Dexrazoxane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2016-02-22 |
| Est. Completion | 2022-07-17 |
| Phase | Phase 2 |
What the finished NCT02584309 record still lists
NCT02584309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Doxorubicin is the first listed.
NCT02584309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02584309 about?
NCT02584309 is a clinical study titled "Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma". The purpose of this research study is to look at whether giving a drug called dexrazoxane with standard of care doxorubicin affects the progression of the disease. Dexrazoxane is often given at the same time as doxorubicin to help reduce the incidence and severity of disease of the heart muscle (whi...
What is the current status of trial NCT02584309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2016-02-22. Estimated completion is 2022-07-17.
What interventions are being tested in trial NCT02584309?
The interventions under investigation include: Doxorubicin (DRUG), Dexrazoxane (DRUG).
Who is sponsoring clinical trial NCT02584309?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02584309's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 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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