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Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

Phase I/II Study to Evaluate the Ability of Sorafenib in Overcoming Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer (AIPC)

NCT00414388•Oncology Specialists, S.C.

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the safety of combining Sorafenib and chemotherapy (mitoxantrone or docetaxel) in patients with AIPC.

Detailed Description

Patients who have AIPC and are progressing despite systemic chemotherapy will be offered participation in this study. Patients who relapse or progress shortly (within 12 weeks) after discontinuation of chemotherapy with either docetaxel/prednisone or mitoxantrone/prednisone will also be offered participation in this trial. Enrolled patients will receive sorafenib as per protocol define dose. Sorafenib will be administered in combination with the last chemotherapy utilized. If there is no disease progression after 6 cycles, chemotherapy will be stopped and Sorafenib may continue until disease progression.

Eligibility

Age

18 - 90 years

Sex

MALE

Healthy Volunteers

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 \< 1.5 x upper limit of normal (ULN)
•Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< 2.5 x the ULN (\< 5 x ULN for patients with liver involvement). international normalized ratio (INR) \< 1.5 or a Prothrombin time (PT)/partial thromboplastin time (PTT) within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate.
+12 more criteria

Exclusion Criteria

•Cardiac disease: Congestive heart failure \> 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.
+6 more criteria

Locations (2)

Onocology Specialists, S.C

Niles, Illinois, United States

Oncology Specialists, S.C

Park Ridge, Illinois, United States

Key Dates

Start Date

December 1, 2006

Primary Completion Date

September 1, 2011

Completion Date

March 1, 2012

Last Updated

April 7, 2014

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Sorafenib

DRUG

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RECRUITINGPHASE2

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 7, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Sorafenib to Overcome Resistance to Systemic Chemotherapy in Androgen-independent Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

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