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

• Conditions: Prostate cancer

• Registration Number: EUCTR2007-003470-26-SE
• Lead Sponsor: Active Biotech Research AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-22
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

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)
•Progression of bone disease:
(New bone lesions by bone scan within the past 12 weeks).
6.Castrate levels of serum testosterone (less than or equals to 50 ng/dL or 1.7 nmol/L. Testosterone levels will not be required for patients who have had bilateral orchiectomy).
7.Karnofsky score 70-100
8.Laboratory values as follows
•Hb = 90g/L (more than or equals to 9 g/dL)
•Serum creatinine = 1.5 times ULN
•Total bilirubin = 1.5 times ULN
•AST (SGOT) / ALT (SGPT) = 2.5 times ULN
•Serum amylase less than or equals to ULN. (If serum amylase more than ULN, pancreatic amylase and serum lipase should be analyzed. If both pancreatic amylase and serum lipase is more than ULN, exclude patient)
9.Patient if sexually active with partner of child bearing potential will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug.
10.No evidence (= 5 years) of prior malignancies (except successfully treated basal cell, squamous cell carcinoma of the skin)
11.Ability to administer and retain oral medication
12.Able to adhere to the study visit schedule and other protocol requirements.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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.
11.Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 14 days prior to inclusion.
12.Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
13.Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic virus hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified