A Study of BAY 43-9006 in Combination With Bicalutamide in Patients With Chemo-Naïve Hormone Refractory Prostate Cancer

NCT00430235 | Completed Phase 2

• 1 other identifier: OZM-001
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: To determine the efficacy of BAY 43-9006 in combination with bicalutamide in patients with chemo-naïve hormone-refractory prostate cancer. Hypothesis: That there will be PSA response when BAY 43-9006 in combination with bicalutamide is given to patients with chemo-naïve hormone-refractory prostate cancer.

Conditions

Adenocarcinoma of the Prostate

Keywords

prostate; cancer; BAY 43-9006

Outcome Measures

Primary Outcomes (1)

• rate of PSA-response

Secondary Outcomes (9)

• time to treatment failure

• time to PSA progression

• duration of PSA response

• median survival time

• 1 year survival rate

Interventions

BAY 43-9006 DRUG

BAY 43-9006, 400 mg, PO, BID in a 28-day cycle(morning and evening) Bicalutamide 50 mg po Once daily in a 28-day cycle (morning)

Eligibility Criteria

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

You may qualify if:

• Patients must have a histologic or cytologic diagnosis of adenocarcinoma of the prostate.
• Patients must have low-bulk asymptomatic metastatic or biochemical recurrent disease for which no curative therapy exists.
• Patients must have documented evidence of PSA progression while receiving androgen ablative therapy, i.e. must be hormone refractory.
• The PSA must be \> 5 μg/L at the time of study entry.
• ECOG performance status of 0 or 1.
• Age 18 years of age or older
• Patients must have a life expectancy of at least 12 weeks.
• Chemotherapy: No prior cytotoxic chemotherapy is permissible. Neoadjuvant or adjuvant chemotherapy is permissible provided it was \> 12 months prior to registration.
• Hormonal Therapy:
• Prior hormone therapy in the form of medical or surgical castration is required. Patients must be hormone refractory and have been previously and currently treated with androgen ablative therapy.
• Patients may have received up to one line of non-steroidal anti- androgens in combination with chemical or surgical castration. Use of prior Bicalutamide is restricted to less than 3 months of continuous usage. Patients must be off anti-androgens for at least 6 weeks prior to study entry.
• Radiation: Prior external beam radiation is permitted provided a minimum of 4 weeks has elapsed between the last dose and enrollment to the trial.
• Steroids. Current treatment with steroids ≤ an equivalent of prednisone 20 mg day is permitted.
• Men of childbearing potential must use an effective form of contraception i.e. double barrier method.
• Laboratory Requirements - within 7 days prior to enrollment Hematology: Hemoglobin ≥ 100g/L Neutrophils \> 1.5 x 109/L Platelets \> 100 x 109/L INR ≤ 1.5 x upper limit of normal Biochemistry: AST, ALT within normal limits Bilirubin within normal limits Serum creatinine ≤1.5 x upper limit of normal

You may not qualify if:

• Prior use of BAY 43-9006 or other VEGF/VEGFR or EGFR targeting agents.
• Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer or other solid tumours curatively treated with no evidence of disease for \> 5 years.
• Patients with known brain metastases or leptomeningeal disease
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 43-9006 or other agents used in the study.
• Other serious intercurrent illness or medical condition that might be aggravated by protocol treatment including:myocardial infarction within 6 months prior to study entry:
• myocardial infarction within 6 months prior to study entry
• congestive heart failure
• unstable angina
• cardiomyopathy
• unstable ventricular arrhythmia
• uncontrolled hypertension (systolic blood pressure ≥ 160, diastolic blood pressure ≥100)
• controlled psychotic disorders
• serious infections
• peptic ulcer disease
• history of bleeding diathesis

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Kim N Chi, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: March 1, 2007
• Primary Completion: August 1, 2010
• Last Updated: August 5, 2010

Record last verified: 2010-08

Locations

CA (1)