Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Sorafenib 100 mg (50-mg tablet)
- description
- Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).
- interventionNames
- Drug: Sorafenib 100 mg (50-mg tablet)
- type
- EXPERIMENTAL
- label
- Sorafenib 200 mg (50-mg tablet)
- description
- Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet). Treatment were planned until primary completion date (PCD).
- interventionNames
- Drug: Sorafenib 200 mg (50-mg tablet)
- type
- EXPERIMENTAL
- label
- Sorafenib 400 mg (50-mg tablet)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available