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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.

Phase 3
18 Years
Open (Enrolling)
Soft Tissue Sarcoma

Thank you

Trial Information

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.

Inclusion 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival followed by Overall Survival

Outcome Time Frame:

assessed every 6 weeks for 22 weeks, then 8 weeks for 6 months/until progression, then every 12 weeks until then death

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2010

Completion Date:

December 2013

Related Keywords:

  • Soft Tissue Sarcoma
  • Metastatic
  • Front line
  • Sarcoma



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