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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

Conditions
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Hormone Refractory Prostate Cancer

Intervention / Treatment
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* Drug: Bafetinib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bafetinib<br> | Drug: Bafetinib<br>* Bafetinib 240 mg bid<br>* Other names: INNO-406;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | The primary objective of this study is to determine the preliminary efficacy of administration of bafetinib in subjects with hormone-refractory prostate cancer (HRPC), as measured by the objective response rate (ORR), which is a combination of CR (PSA ≤0.12 ng/mL) and PR (≥50% reduction in PSA from baseline). | At six months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The safety of bafetinib in this population assessed by the frequency and severity of adverse events (AEs), abnormal findings on physical examination, laboratory tests, and vital signs. | At six months. | 
| Progression-free survival | Progression-free survival is defined as the time from enrollment to first documentation of objective PSA or tumor progression, or to death due to any cause in the absence of previous documentation of objective tumor progression. | At six months. | 
| Objective tumor response | The total proportion of subjects who have an objective tumor reponse (CR + PR) using the RECIST criteria. | At six months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hormone Refractory Prostate Cancer, HRPC