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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CytRx
ClinicalTrials.gov Identifier:
NCT01215799
First received: September 30, 2010
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Hormone Refractory Prostate Cancer
Drug: Bafetinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bafetinib (INNO-406) as Treatment for Patients With Hormone-Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by CytRx:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: At six months. ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Safety [ Time Frame: At six months. ] [ Designated as safety issue: Yes ]
    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.

  • Progression-free survival [ Time Frame: At six months. ] [ Designated as safety issue: No ]
    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.

  • Objective tumor response [ Time Frame: At six months. ] [ Designated as safety issue: No ]
    The total proportion of subjects who have an objective tumor reponse (CR + PR) using the RECIST criteria.


Enrollment: 23
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bafetinib Drug: Bafetinib
Bafetinib 240 mg bid
Other Name: INNO-406

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215799

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Sponsors and Collaborators
CytRx
Investigators
Study Director: Daniel Levitt, M.D., Ph.D. Chief Medical Officer, CytRx Corporation
  More Information

No publications provided

Responsible Party: CytRx
ClinicalTrials.gov Identifier: NCT01215799     History of Changes
Other Study ID Numbers: BAFETINIB-P2-HRPC-01
Study First Received: September 30, 2010
Last Updated: December 14, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by CytRx:
Hormone Refractory Prostate Cancer
HRPC

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014