Clinical trial NCT01215799: Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer
Official title: A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hormone Refractory Prostate Cancer
Keywords: Hormone Refractory Prostate Cancer
HRPC
Lead sponsor: CytRx
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 outcomes:
measure: Objective Response Rate
timeFrame: At six months.
Secondary outcomes:
measure: Safety
timeFrame: At six months.
measure: Progression-free survival
timeFrame: At six months.
measure: Objective tumor response
timeFrame: At six months.
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: Chief Medical Officer, CytRx Corporation
name: Daniel Levitt, M.D., Ph.D.
role: STUDY_DIRECTOR
References: