Trials / Completed
CompletedNCT00941863
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2002-07-01
- Primary completion
- 2005-05-01
- Completion
- 2008-04-01
- First posted
- 2009-07-20
- Last updated
- 2016-03-22
- Results posted
- 2010-10-08
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00941863. Inclusion in this directory is not an endorsement.