NCT01242072

Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies

A Phase I Study of Intravenous (IV) Palifosfamide-tris Administered in Combination With IV Etoposide and IV Carboplatin in Patients With Malignancies for Which Etoposide and Carboplatin Are an Appropriate Choice

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Alaunos Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This an an open-label study to define the safety profile and the maximum tolerated dose and confirm the clinical effective dose of palifosfamide-tris given intravenously in combination with etoposide and carboplatin in a wide range of cancers which etoposide and carboplatin are normally given. Once the maximum dose of palifosfamide-tris is determined,a Phase II study using the 3 agents combined will begin.

Conditions

• Malignancy
• Cancer
• Non Small Cell Lung Cancer
• Small Cell Lung Cancer
• Testicular Cancer
• Thymoma
• Ovarian Cancer
• Osteosarcoma

Interventions

Type	Name	Description
DRUG	palifosfamide-tris	Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-11-16
• Last updated: 2012-07-18

Locations

4 sites across 1 country: United States