Conditions: Carcinoma
Keywords: Sorafenib Advanced Solid Tumors Maximum tolerated dose Carboplatin and paclitaxel chemotherapy combination
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
The primary objective of the study was to define the safety profile and maximum tolerated dose (MTD) of sorafenib tablets in combination with carboplatin and paclitaxel chemotherapy in patients with advanced, refractory solid tumors.

The secondary objectives were evaluation of pharmacokinetics (PK) and tumor response of these patients being treated with sorafenib in combination with paclitaxel and carboplatin.

Detailed description:

Arms:
arm 1: Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 2: Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 3: Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD). arm 4: Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet). Treatment were planned until primary completion date (PCD). arm 5: Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion. Treatment were planned until primary completion date (PCD). 25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib until 18 Sep 2008.

Interventions: intervention 1: Sorafenib 100 mg (50-mg tablet) intervention 2: Sorafenib 200 mg (50-mg tablet) intervention 3: Sorafenib 400 mg (50-mg tablet) intervention 4: Sorafenib 400 mg (200-mg tablet) intervention 5: Sorafenib 400 mg (Expansion)
Intervention descriptions: intervention 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet) intervention 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet) intervention 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet) intervention 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) intervention 5: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion

Protocol document: