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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sorafenib 100 mg (50-mg tablet)

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

Group Type EXPERIMENTAL

Sorafenib 100 mg (50-mg tablet)

Intervention Type DRUG

Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)

Sorafenib 200 mg (50-mg tablet)

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

Group Type EXPERIMENTAL

Sorafenib 200 mg (50-mg tablet)

Intervention Type DRUG

Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)

Sorafenib 400 mg (50-mg tablet)

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

Group Type EXPERIMENTAL

Sorafenib 400 mg (50-mg tablet)

Intervention Type DRUG

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)

Sorafenib 400 mg (200-mg tablet)

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

Group Type EXPERIMENTAL

Sorafenib 400 mg (200-mg tablet)

Intervention Type DRUG

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)

Sorafenib 400 mg (Expansion)

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.

Group Type EXPERIMENTAL

Sorafenib 400 mg (Expansion)

Intervention Type DRUG

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion

Interventions

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Sorafenib 100 mg (50-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)

Intervention Type DRUG

Sorafenib 200 mg (50-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)

Intervention Type DRUG

Sorafenib 400 mg (50-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)

Intervention Type DRUG

Sorafenib 400 mg (200-mg tablet)

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)

Intervention Type DRUG

Sorafenib 400 mg (Expansion)

Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No