Phase I-II Trial of Sorafenib in Combination With Ifosfamide in Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00541840|
Recruitment Status : Unknown
Verified May 2008 by Grupo Espanol de Investigacion en Sarcomas.
Recruitment status was: Recruiting
First Posted : October 10, 2007
Last Update Posted : May 12, 2008
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Sorafenib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I-II, Not-Randomized, Multicenter Clinical Trial to Evaluate Safety and Efficacy of Sorafenib (BAY-43-9006) in Combination With Ifosfamide in Soft Tissue Sarcoma.|
|Study Start Date :||October 2007|
|Estimated Primary Completion Date :||April 2009|
|Estimated Study Completion Date :||April 2010|
Level 1: Sorafenib 200 mg bid, orally Ifosfamide 2,0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
Level 2: Sorafenib 400 mg bid, orally Ifosfamide 2.00 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 400 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
Level 3 : Sorafenib 400mg bid, orally Ifosfamide 2.5 g/m2 , intravenously , over 4 hours , on 3 consecutive days . Mesna 500mg/m2,iv,at 0,4 and 8 hours after ifosfamide administration .
Level 4 : Sorafenib 400 mg bid, orally Ifosfamide 3.0 g/m2, intravenously, over 4 hours, on 3 consecutive days Mesna 600 mg/m2 iv, at 0, 4 and 8 hours after the Ifosfamide administration
Sorafenib and Ifosfamide administered at the doses recommended in phase I until progression or unacceptable toxicity.
- Phase I: Safety profile and to determine maximum tolerated dose (MTD) / Recommended Dose (DR) of Sorafenib in combination with Ifosfamide. Phase II: Activity profile evaluating of the combination in patients with advanced soft tissue sarcoma. [ Time Frame: Phase II: Progression free rate: at 3 and 6 months ]
- Phase II: Efficacy evaluation [ Time Frame: Phase II: Progression free rate at 3 and 6 months ]
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): NCT00541840
|Contact: Xavier Garcia del Muro, MD||93 260 73 firstname.lastname@example.org|
|Madrid, Spain, 28001|
|Contact: Xavier Garcia del Muro, MD 915775281 email@example.com|
|Principal Investigator: Xavier Garcia del Muro, MD|
|Study Director:||Xavier Garcia del Muro, MD||Grupo Español de Investigacion en Sarcomas (GEIS)|