Clinical trial · Interventional
Phase I Study of Sorafenib Dosed Continuously With Cyclophosphamide and Doxorubicin
Phase I Open-label, Non-randomized, Non-placebo Controlled Study to Determine the Safety, Pharmacokinetics, and Tumor Response Profile of Sorafenib as Continuous Dosing in Combination With Cyclophosphamide and Doxorubicin in Patients With Advanced, Refractory Solid Tumors
NCT00562913CI-TRIAL-00012751completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
Study to access the safety, levels of drug in the blood and tumor effects of sorafenib dosed daily combined with Cyclophosphamide and Doxorubicin in cancer patients
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nexavar (Sorafenib, BAY43-9006) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm 1
- interventionNames
- Drug: Nexavar (Sorafenib, BAY43-9006)
Primary outcomes (1)
- measure
- To determine the pharmacokinetics and safety of cyclophosphamide when co-administered with 400 mg BID sorafenib and doxorubicin administered
- timeFrame
- 6 weeks
Secondary outcomes (1)
- measure
- To evaluate the tumor response to the combination of cyclophosphamide, doxorubicin and sorafenib
- timeFrame
- 6 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years old * Advanced histological or cytological documentation of cancer * life-expectancy of at least 12 weeks * able to swallow pills * ECOG status of 0,1 or 2 * adequate bone marrow * liver and renal function Exclusion Criteria: * \> NYHA Class 2 CHF * Serious myocardial dysfunction, * or symptomatic coronary artery disease (MI more than 6 months prior to study entry is allowed) * History of organ allograft * uncontrolled hypertension * renal dialysis * Bleeding event/hemorrhage within 4 weeks of study treatment * major surgery within 4 weeks of study treatment * Previous exposure to doxorubicin or other anthracyclines exceeding a maximum lifetime cumulative dose
References
Publications (0)
Data not yet available
No reference posted for this study.