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NCT01259375 · ClinicalTrials.gov registry record · Phase 2
Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma
A Phase 2 study, sponsored by University of Utah.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT01259375 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 24 participants.
The verdict
NCT01259375, a Phase 2 study, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
Primary Objectives 1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced sarcoma as first line therapy. 2. To evaluate Progression Free Survival (PFS). Secondary Objectives 1. To assess the safety and tolerability of amrubicin in this patient population. 2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential response to amrubicin. 3. To investigate quality of response with radiographic evaluation using both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria. 4. To evaluate overall survival (OS).
Interventions
- DRUG Amrubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01259375
The ClinicalTrials.gov registry entry for NCT01259375 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Amrubicin is the first listed.
NCT01259375 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01259375 about?
NCT01259375 is a clinical study titled "Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma". Primary Objectives 1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced sarcoma as first line therapy. 2. To evaluate Progression Free Survival (PFS). Secondary Objectives 1. To assess the safety and tolerability of amrubicin in this patient population. 2. T...
What is the current status of trial NCT01259375?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2011-09. Estimated completion is 2016-02.
What interventions are being tested in trial NCT01259375?
The interventions under investigation include: Amrubicin (DRUG).
Who is sponsoring clinical trial NCT01259375?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
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