Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients with Metastatic Castrate-Resistant Prostate Cancer. Final Protocol dated 2007-06-19, Protocol Amendment 1 dated 2007-08-06, Protocol Amendment 2 dated 2007-08-16, Protocol Amendment 3 dated 2007-10-31, Protocol Amendment 4 dated 2007-12-17, Protocol Amendment 5 dated 2008-04-14, Protocol Amendment 6 dated 2008-09-09, Protocol Amendment 7 dated 2009-04-15

Active Biotech Research AB0 sites200 target enrollmentAugust 22, 2007

Overview

No summary available.

Registry

who.int

Start Date

August 22, 2007

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Sponsor

•In order to participate in the study patients must be (have):
•1\.Age \=18 years at the time of signing the informed consent form.
•2\.Histologically confirmed diagnosis of adenocarcinoma of the prostate.
•3\.Asymptomatic metastatic CRPC (VAS pain score \=3\). The patient may take non\-opioid analgesics for non\-cancer pain discomfort.
•4\.Evidence of metastatic disease from CT or Bone scan
•5\.Evidence of progressive disease after castration levels of testosterone have been achieved defined by any of the following criteria:
•Increased serum prostate\-specific antigen (PSA) levels
•(Confirmed by 3 consecutive PSA measurements within 1 year with at least 14 days between each measurement)
•Progression of bidimensionally measurable soft tissue (nodal) metastasis:
•(CT scan or MRI)

•1\.Prior cytotoxic chemotherapy within 3 years.
•2\.Previous anticancer therapy using biologics or vaccines within the last 6 months. Previous treatment with bevacizumab is not allowed.
•3\.Any treatment modalities, involving radiation and surgery, not discontinued at least 4 weeks prior to treatment in this study.
•4\.Myocardial infarction or any acute coronary syndrome within one year or current uncontrolled arrhythmias, symptomatic uncontrolled congestive heart failure, unstable angina pectoris, uncontrolled hypertension.
•5\.History of pancreatitis.
•6\.Any condition, including the presence of laboratory abnormalities, which confounds the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
•7\.Concurrent use of other anti\-cancer agents or treatments (a stable dose of LHRH agonists, bicalutamide (e.g. Casodex) and/or other antiandrogens is allowed).
•8\.Known brain metastases.
•9\.Simultaneous participation in any other study involving investigational drugs or having participated in a study less than 4 weeks prior to start of study treatment.
•10\.Concomitant systemic treatment with warfarin and/or corticosteroids corresponding to a prednisolone dose above 5 mg/day.