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Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma (PICASSO III)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168791
First Posted: July 23, 2010
Last Update Posted: July 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ziopharm
July 21, 2010
July 23, 2010
July 18, 2013
July 2010
March 2013   (Final data collection date for primary outcome measure)
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 ]
Overall Survival [ Time Frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until death ]
Complete list of historical versions of study NCT01168791 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Safety and Tolerability as evaluated using CTCAE v 4.0 [ Time Frame: 22 weeks ]
  • Progression Free Survival [ Time Frame: assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months, then every 12 weeks until disease progression ]
  • Quality of Life [ Time Frame: 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 [ Time Frame: 22 weeks ]
Not Provided
Not Provided
 
Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma
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.
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Soft Tissue Sarcoma
  • 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.

  • 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.

  • Experimental: doxorubicin plus palifosfamide-tris
    Intervention: Drug: doxorubicin in combination with palifosfamide-tris
  • Active Comparator: doxorubicin plus placebo
    Intervention: Drug: doxorubicin in combination with placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
447
March 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Belgium,   Brazil,   Canada,   Chile,   Colombia,   France,   Germany,   Guatemala,   India,   Israel,   Italy,   Panama,   Poland,   Romania,   Russian Federation,   Singapore,   Spain,   United Kingdom,   United States
Korea, Republic of
 
NCT01168791
IPM3001
Yes
Not Provided
Not Provided
Ziopharm
Ziopharm
Not Provided
Not Provided
Ziopharm
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP