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Duarte, California 91010


This is a Phase II open-label study evaluating the preliminary efficacy and safety of bafetinib administered as 240 mg orally twice daily in subjects with Hormone Refractory Prostate Cancer.


Inclusion Criteria: - Males age ≥18 years. - Histologically confirmed diagnosis of adenocarcinoma of the prostate. - Hormone-refractory prostate cancer having progressed despite androgen deprivation therapy that resulted in a castrated level of testosterone (<50 ng/dL) or orchiectomy; with or without evidence of measurable or evaluable disease. - PSA increase defined as 2 consecutive rises; first increase in PSA occurred a minimum of 1 week from the reference value; increase in PSA should be at least 25% above the reference value and absolute PSA value should be >5 ng/mL. - May have received no more than 1 prior chemotherapy regimen. Prior immunomodulatory therapy (sipuleucel-t (Provenge), interferon) is allowed. - Must be taking a single agent LHRH agonist or antagonist, unless previously underwent orchiectomy. - ECOG performance status 0-2. - Able to swallow pills. - Able to provide written, voluntary informed consent, comply with trial procedures, and have accessibility to the site. Exclusion Criteria: - Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of study enrollment - Exposure to any investigational agent within 30 days of the Screening Visit. - No prior flutamide (Eulexin) and ketoconazole use within 4 weeks, bicalutamide (Casodex) within 6 weeks or nilutamide (Nilandron) within 6 weeks of study enrollment. - Use of Quadramet therapy during 2 months prior to study enrollment or Metastron ever. - Prior treatment with a tyrosine kinase inhibitor. - Subjects who have started bisphosphonate therapy within 4 weeks of study enrollment are excluded. Subjects treated with a stable dose of a bisphosphonate for >4 weeks and the tumor has still progressed can be enrolled in the study. - Known CNS disease or CNS metastases. - History of other malignancies within the last five years except curatively treated basal cell carcinoma or superficial bladder cancer. - Laboratory values: Screening serum creatinine greater than or equal to 1.5 x ULN, alanine aminotransferase (ALT) greater than 3 times the upper limit of normal, total bilirubin greater than 3 times the upper limit of normal, white blood cell (WBC) count <3500/mm3, absolute neutrophil count <1500/mm3, hematocrit level <35% and platelets <100,000/mm3. - History of abnormal bleeding or use of anticoagulant therapy. - Clinically evident congestive heart failure >class II of the New York Heart Association (NYHA) guidelines. - Serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V. - History of MI within 6 months or uncontrolled angina within 3 months. - Severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, chronic renal disease, chronic liver disease. - Known HIV infection. - Uncontrolled active, infection. - Substance abuse or any condition that might interfere with the subject's participation in the study or in the evaluation of the study results. - Any condition that in the opinion of the Investigator is unstable and could jeopardize the subject's participation in the study.



Primary Contact:

Study Director
Daniel Levitt, M.D., Ph.D.
Chief Medical Officer, CytRx Corporation

Backup Contact:


Location Contact:

Duarte, California 91010
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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