Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
(PICASSO III Trial)
Recruiting in Palo Alto (17 mi)
+161 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Ziopharm
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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).
Research Team
Eligibility Criteria
Inclusion Criteria
Age ≥18 years.
Documented soft tissue sarcoma
Metastatic disease for which the patient has not received any prior treatment, and for whom treatment with doxorubicin is considered medically acceptable.
See 7 more
Treatment Details
Interventions
- Doxorubicin (Alkylating agents)
- Palifosfamide-tris (Alkylating agents)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: doxorubicin plus palifosfamide-trisExperimental Treatment1 Intervention
Group II: doxorubicin plus placeboActive Control1 Intervention
Doxorubicin is already approved in Canada, Japan for the following indications:
Approved in Canada as Doxorubicin for:
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
Approved in Japan as Doxorubicin for:
- Breast cancer
- Ovarian cancer
- Bladder cancer
- Lymphomas
- Leukemias
- Multiple myeloma
- Kaposi's sarcoma
- Soft tissue sarcomas
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NCT01168791Orlando, FL
Moffitt Cancer CenterTampa, FL
University of Colorado Cancer CenterAurora, CO
Summa Health SystemAkron, OH
More Trial Locations
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Who Is Running the Clinical Trial?
Ziopharm
Lead Sponsor
Trials
36
Patients Recruited
4,000+
Alaunos Therapeutics
Lead Sponsor
Trials
41
Patients Recruited
4,200+