A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer
- 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
- 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.
- Chemotherapy, antibody therapy, major surgery or irradiation within 4 weeks of
- 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
- 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
- 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.