Phase 1
Completed N=158
Study to Determine the Safety, Maximum Tolerated Dose, Pharmacokinetics of Sorafenib (BAY43-9006)
Carcinoma
Source: ClinicalTrials.gov NCT00941863 ↗
Enrolled (actual)
158
Serious AEs
62.7%
Results posted
Oct 2010
Primary outcomePrimary: Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin — 400 mg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Sorafenib in Combination With Paclitaxel and Carboplatin |
400 | — |
| PRIMARY Participants With Hematological and Biochemical Toxicities |
1; 0; 2; 5; 28; 6 | — |
| SECONDARY Tumor Response |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Area Under the Curve From Time 0 to 12 Hours Post-dose (AUC 0-12) Start From Day 2 of Cycle 1 |
17.5 | — |
| SECONDARY Maximum Concentration (CMAX) Start From Day 2 of Cycle 1 |
3.36 | — |
| SECONDARY Time of Maximum Concentration (TMAX) Start From Day 2 of Cycle 1 |
24.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00941863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.