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Amrubicin Chemotherapy as First Line in Metastatic or Unresectable Soft Tissue Sarcoma

NCT01259375 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-04-17

Study results available
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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).

Conditions

  • Soft Tissue Sarcoma

Interventions

DRUG

Amrubicin

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259375 on ClinicalTrials.gov