NCT00881166

Safety of MP470 in Combination With Standard-of-Care Chemotherapy Regimens to Treat Solid Tumors

Safety and Dose Finding Study of Oral MP470, a Multi-targeted Tyrosine Kinase Inhibitor, in Combination With Standard-of-Care Chemotherapy Regimens

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Astex Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Adult subjects with malignant disease appropriate for treatment with carboplatin/paclitaxel, carboplatin/etoposide, topotecan, docetaxel or erlotinib according to the standard dosing regimen will be enrolled in each treatment arm. Primary objective: Determine the MTD. Secondary objectives: Response rates, PK, quantify MP-470 on PK of SOC, and collect pharmacodynamic information. Evaluate the overall safety of MP-470 when co-administered with specific SOC treatments.

Conditions

• Malignant Disease

Interventions

Type	Name	Description
DRUG	MP-470 + topotecan	Topotecan 1.5 mg/m2 IV infusion over 30 minutes on Days 1-5
DRUG	MP-470 + docetaxel	Docetaxel 75 mg/m2 IV infusion over 1 hour on Day 1
DRUG	MP-470 + erlotinib	150 mg PO once daily at least 1 hour before or 2 hours after eating
DRUG	MP-470 + paclitaxel/carboplatin	Paclitaxel 200 mg/m2 IV infusion over 3 hours followed by carboplatin IV infusion over 1 hour to a target AUC of 6 mg∙min/mL on Day 1
DRUG	MP-470 + carboplatin/etoposide	Carboplatin IV infusion over 1 hour to target AUC of 5 mg min/mL on Day 1 followed by etoposide 100 mg/m2 IV infusion over 2 hours on Days 1-3

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-04-15
• Last updated: 2024-08-02

Locations

5 sites across 1 country: United States