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

NCT00941863 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2016-03-22

Study results available
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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.

Conditions

  • Carcinoma

Interventions

DRUG

Sorafenib 100 mg (50-mg tablet)

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

DRUG

Sorafenib 200 mg (50-mg tablet)

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

DRUG

Sorafenib 400 mg (50-mg tablet)

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

DRUG

Sorafenib 400 mg (200-mg tablet)

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

DRUG

Sorafenib 400 mg (Expansion)

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Primary Completion
2005-05-31
Completion
2008-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941863 on ClinicalTrials.gov