Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CytRx
• Treatments: Bafetinib; Hormones

Criteria

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.