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

NCT01215799 | Completed Phase 2 DMC

• 1 other identifier: BAFETINIB-P2-HRPC-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Hormone Refractory Prostate Cancer

Keywords

Hormone Refractory Prostate Cancer; HRPC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Safety

  At six months.

• Progression-free survival

  At six months.

• Objective tumor response

  At six months.

Study Arms (1)

Bafetinib

EXPERIMENTAL

Drug: Bafetinib

Interventions

Bafetinib DRUG

Bafetinib 240 mg bid

Also known as: INNO-406

Bafetinib

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CytRx: lead

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Interventions

bafetinib

Study Officials

• Daniel Levitt, M.D., Ph.D.

  Chief Medical Officer, CytRx Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 7, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 15, 2011

Record last verified: 2011-12

Locations

US (1)