At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 158 enrolled

Drug / intervention

Sorafenib 100 mg (50-mg tablet) +4 moredrug

Likely dose

Sorafenib 100 mg (50-mg tablet)from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00941863

NCT00941863Phase 1Completed

Compare CT.gov

Phase I Study to Determine the Safety, Maximum Tolerated Dose, PK of BAY43-9006 in Repeated Cycles of 18 Days On/3 Days Off in Combination With Paclitaxel and Carboplatin Chemotherapy in Patients With Advanced, Refractory Solid Tumors

Bayer·interventional·Posted Jul 20, 2009·Updated Mar 22, 2016

In Brief

A Phase 1 clinical trial evaluating Sorafenib 100 mg (50-mg tablet), Sorafenib 200 mg (50-mg tablet), and 3 other interventions for Carcinoma. Completed, enrolled 158 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCarcinoma

CountriesUnited States

CollaboratorsAmgen

Timeline

Phase 1CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJul 2002

Primary CompletionMay 2005

Study CompletionApr 2008

First PostedJul 2009

TodayJul 2026

First PostedJul 20, 2009

Enrollment StartJul 1, 2002

Primary CompletionMay 1, 2005

Study CompletionApr 1, 2008

TodayJul 2, 2026

Enrollment to primary: 2.8 yearsPosted 16.9 years ago

Interventions

Sorafenib 100 mg (50-mg tablet)drug

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

Sorafenib 200 mg (50-mg tablet)drug

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

Sorafenib 400 mg (50-mg tablet)drug

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

Sorafenib 400 mg (200-mg tablet)drug

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

Sorafenib 400 mg (Expansion)drug

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