Study of Palifosfamide-tris in Combination With Doxorubicin in Patients With Front-line Metastatic Soft Tissue Sarcoma (PICASSO III)
|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.|
|ClinicalTrials.gov Identifier: NCT01168791|
Recruitment Status : Completed
First Posted : July 23, 2010
Last Update Posted : July 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: doxorubicin in combination with palifosfamide-tris Drug: doxorubicin in combination with placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||447 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|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.
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168791