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| Sponsor: | ZIOPHARM |
|---|---|
| Information provided by (Responsible Party): | ZIOPHARM |
| ClinicalTrials.gov Identifier: | NCT01168791 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Soft Tissue Sarcoma |
Drug: doxorubicin in combination with palifosfamide-tris Drug: doxorubicin in combination with placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
| Estimated Enrollment: | 424 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: doxorubicin plus palifosfamide-tris |
Drug: doxorubicin in combination with palifosfamide-tris
palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles. doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles. |
| Active Comparator: doxorubicin plus placebo |
Drug: doxorubicin in combination with placebo
doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles. placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles. |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
To be eligible, each patient must meet EACH of the following criteria:
To be eligible, each patient must meet NONE of the following criteria:
Contacts and Locations| Contact: Jill Buck | 617-259-1984 | jbuck@ziopharm.com |
| Contact: Nikia Murchie | 617-502-1875 | nmurchie@ziopharm.com |
Show 161 Study Locations
More Information
| Responsible Party: | ZIOPHARM |
| ClinicalTrials.gov Identifier: | NCT01168791 History of Changes |
| Other Study ID Numbers: | IPM3001 |
| Study First Received: | July 21, 2010 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada United Kingdom: Medicines and Healthcare Products Regulatory Agency Spain: Agencia Española de Medicamentos y Productos Sanitarios Romania: National Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Italy: The Italian Medicines Agency Germany: Ministry of Health France: Afssaps - French Health Products Safety Agency Belgium: Federal Agency for Medicinal Products and Health Products Israel: Ministry of Health Argentina: Ministry of Health Brazil: Ministry of Health Chile: Instituto de Salud Publica de Chile Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Guatemala: Ministry of Public Health and Social Assistance Panama: Ministry of Health Australia: Department of Health and Ageing Therapeutic Goods Administration Korea: Food and Drug Administration |
|
Metastatic Front line |
|
Sarcoma Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Doxorubicin Isophosphamide mustard Ifosfamide |
Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |