Phase 2
Completed N=22
Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer
Source: ClinicalTrials.gov NCT00414388 ↗Enrolled (actual)
22
Serious AEs
54.6%
Results posted
Apr 2014
Primary outcomePrimary: Percentage of Patients Needing a Dose Reduction. — 71 percentage of participants
Summary
The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Needing a Dose Reduction. |
71 | — |
| SECONDARY Overall Clinical Benefit (OCB)of This Combination as Calculated by the Sum of Complete Response (CR), Partial Response (PR), and Stable Disease (SD). |
76 | — |
| SECONDARY PSA -Biochemical Response |
45 | — |
Eligibility Criteria
Inclusion Criteria
- Age > 18 years old
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2.
- Patients with a known diagnosis of prostate cancer regardless of their Gleason grade.
- Patients have AIPC.
- Adequate bone marrow, liver and renal function as assessed by:
- Hemoglobin > 9.0 g/dl
- absolute neutrophil count (ANC) > 1,000/mm3
- Platelet count > 75,000/mm3
- Total bilirubin class II New York Heart Association 9NYHA). Patients must not have unstable angina or new onset angina or myocardial infarction within the past 6 months.
- Known brain metastasis. Patients with neurological symptoms must undergo a CT scan or MRI of brain to exclude brain metastasis.
- Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy. Patients with history of chronic and well controlled atrial fibrillation are allowed. Beta-blockers, calcium channel blockers, or digoxin are not considered anti-arrhythmics.
- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- Active clinically serious infection > Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2.
- Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
- Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
- Serious non-healing wound, ulcer, or bone fracture.
- Evidence or history of bleeding diathesis or uncontrolled coagulopathy.
- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
- Use of St. John's Wort or rifampin (rifampicin).
- Known or suspected allergy to sorafenib or any agent given in the course of this trial.
- Any condition that impairs patient's ability to swallow whole pills.
Data sourced from ClinicalTrials.gov (NCT00414388). 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.