Status:
COMPLETED
Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer
Lead Sponsor:
CytRx
Conditions:
Hormone Refractory Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01215799
Start Date
August 1 2010
End Date
December 1 2011
Last Update
December 15 2011
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010