CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Amrubicindrug
Likely dose
Amrubicin 40mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01259375
NCT01259375Phase 2Completed
CompareCT.gov

A Phase II Study of Amrubicin Chemotherapy as First Line Treatment in Patients With Metastatic or Unresectable Soft Tissue Sarcoma

University of Utah·interventional·Posted Dec 14, 2010·Updated Apr 17, 2017

In Brief

A Phase 2 clinical trial evaluating Amrubicin for Soft Tissue Sarcoma. Completed, enrolled 24 participants across 2 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSoft Tissue Sarcoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2010
Enrollment StartSep 1, 2011
Primary CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 15.5 years ago

Interventions

Amrubicindrug

Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously