Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin

Outcome Description:

MTD was determined by testing increasing doses up to 400 mg twice daily (bid) on dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (= Dose Limiting Toxicity (DLT) in more than 30% of patients; e.g., hematologic toxicities like CTC Grade 4 Neutropenia in specific conditions, platelets < 25,000 cells/mL; specific non-hematologic/biochemical toxicities CTC Grade 3 or 4; additionally, any toxicity considered by the investigator severe enough was designated a DLT); Common Toxicity Criteria (CTC) Version 2 were used.

Outcome Time Frame:

21 days

Safety Issue:

Yes

Principal Investigator

Bayer Study Director

Investigator Role:

Study Director

Investigator Affiliation:

Bayer

Authority:

United States: Food and Drug Administration

Study ID:

100375

NCT ID:

NCT00941863

Start Date:

July 2002

Completion Date:

April 2008

Related Keywords:

• Carcinoma
• Sorafenib
• Advanced Solid Tumors
• Maximum tolerated dose
• Carboplatin and paclitaxel chemotherapy combination
• Carcinoma