Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma (PICASSO III)
This study is ongoing, but not recruiting participants.
Sponsor:
ZIOPHARM
Information provided by (Responsible Party):
ZIOPHARM
ClinicalTrials.gov Identifier:
NCT01168791
First received: July 21, 2010
Last updated: July 16, 2012
Last verified: July 2012
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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. |
Resource links provided by NLM:
Further study details as provided by ZIOPHARM:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life, as assessed by EORTC QLQ-C30 and EQ-5D questionnaires [ Time Frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death ] [ Designated as safety issue: No ]
- Safety and Tolerability as evaluated using CTCAE v 4.0 [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 424 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 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 |
Criteria
To be eligible, each patient must meet EACH of the following 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.
- ECOG Performance Status of 0, 1 or 2
- Adequate bone marrow and organ function based on the results of protocol- specified laboratory tests
- Male and female patients must agree to use a highly reliable method of birth control during study participation.
- Able to provide informed consent
To be eligible, each patient must meet NONE of the following criteria:
- Specific sarcoma histological subtypes including GIST and Ewing's sarcoma.
- Systemic therapy for the treatment of metastatic sarcoma, prior to or during the study. However, patients may have received neo-adjuvant/adjuvant Gemzar and Taxotere chemotherapy for their primary sarcoma, prior to the development of metastatic disease
- Any prior anthracycline use.
- Known allergy to any of the study drugs or their excipients.
- Any unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a patient and/or their compliance with the protocol, based on screening tests, physical examination and medical history (as specifically defined in the clinical protocol).
- Myocardial dysfunction defined as left ventricular ejection fraction (LVEF) <50%.
- Documented metastases to brain or meninges.
- Any malignancy other than sarcoma within the last 5 years prior to screening, with the exception of cervical carcinoma in situ, basal cell carcinoma, or superficial bladder tumors (Ta, Tis, or T1) that have been successfully and curatively treated with no evidence of recurrent or residual disease.
- Currently pregnant or nursing.
- Radiotherapy with curative intent within 4 weeks of first dose of study drug.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01168791
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Show 162 Study LocationsSponsors and Collaborators
ZIOPHARM
More Information
No publications provided
| Responsible Party: | ZIOPHARM |
| ClinicalTrials.gov Identifier: | NCT01168791 History of Changes |
| Other Study ID Numbers: | IPM3001 |
| Study First Received: | July 21, 2010 |
| Last Updated: | July 16, 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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) 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 |
Keywords provided by ZIOPHARM:
|
Metastatic Front line |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 18, 2013