Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)

Bayer

Status and phase: Completed; Phase 1

Conditions: Carcinoma

Treatments: Drug: Sorafenib 400 mg (50-mg tablet); Drug: Sorafenib 400 mg (200-mg tablet); Drug: Sorafenib 100 mg (50-mg tablet); Drug: Sorafenib 200 mg (50-mg tablet); Drug: Sorafenib 400 mg (Expansion)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00941863

100375

Details and patient eligibility

About

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.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed solid tumors
• Evaluable disease
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Life expectancy minimum 12 weeks

Exclusion criteria

• Congestive heart failure
• Serious arrhythmias
• Coronary artery disease (CAD) or ischemia
• HIV (human immunodeficiency virus)
• Hepatitis B or C
• Serious active infection
• Metastatic brain or meningeal tumors

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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158 participants in 5 patient groups

Sorafenib 100 mg (50-mg tablet)

Experimental group

Description:

Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).

Treatment:

Drug: Sorafenib 100 mg (50-mg tablet)

Sorafenib 200 mg (50-mg tablet)

Experimental group

Description:

Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).

Treatment:

Drug: Sorafenib 200 mg (50-mg tablet)

Sorafenib 400 mg (50-mg tablet)

Experimental group

Description:

Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).

Treatment:

Drug: Sorafenib 400 mg (50-mg tablet)

Sorafenib 400 mg (200-mg tablet)

Experimental group

Description:

Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet). Treatment were planned until primary completion date (PCD).

Treatment:

Drug: Sorafenib 400 mg (200-mg tablet)

Sorafenib 400 mg (Expansion)

Experimental group

Description:

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.

Treatment:

Drug: Sorafenib 400 mg (Expansion)