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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: Completed Phase 2 study, sponsored by University of Utah.
NCT01259375 is a Phase 2 study that has completed, run by University of Utah. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Per response evaluation criteria in solid tumors criteria (RECIST 1.1) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR) \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Interventions
- DRUG Amrubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2011-09 |
| Est. Completion | 2016-02 |
| Phase | Phase 2 |
What the finished NCT01259375 record still lists
NCT01259375 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which Amrubicin is the first listed.
NCT01259375 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01259375's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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