NCT01168791CompletedPhase 3
A Phase III Multicenter, International, Randomized, Double-blind, Placebo-controlled Study of Doxorubicin Plus Palifosfamide-tris vs. Doxorubicin Plus Placebo in Patients With Front-line Metastatic Soft Tissue Sarcoma.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Alaunos Therapeutics
- Enrollment
- 447
- Locations
- 78
- Primary Endpoint
- Progression Free Survival followed by Overall Survival
Study Overview
Brief Summary
This is an international, randomized, double-blind, placebo-controlled trial to evaluate the clinical efficacy of palifosfamide-tris administered with doxorubicin in combination, compared with doxorubicin administered with placebo in front-line patients diagnosed with metastatic soft tissue sarcoma (STS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
doxorubicin plus palifosfamide-tris
Experimental
Intervention: doxorubicin in combination with palifosfamide-tris (Drug)
doxorubicin plus placebo
Active Comparator
Intervention: doxorubicin in combination with placebo (Drug)
Outcomes
Primary Outcomes
Progression Free Survival followed by Overall Survival
Time Frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death
Secondary Outcomes
- Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires(assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death)
- Safety and Tolerability as evaluated using CTCAE v 4.0(22 weeks)
Investigators
Study Sites (78)
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