Efficacy Study of ABR-215050 to Treat Prostate Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00560482
• Date of registration: 15/11/2007
• Primary sponsor: Active Biotech AB
• Public title: Efficacy Study of ABR-215050 to Treat Prostate Cancer
• Scientific title: Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer
• Date of first enrolment: December 2007
• Target sample size: 206
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00560482
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Canada, Sweden, United States

Contacts

• Name: Goran Forsberg, Assoc. Prof.
• Affiliation: Active Biotech AB

• Name: Roberto Pili, MD
• Affiliation: Roswell Park Cancer Institute, Buffalo, New York

Key inclusion & exclusion criteria

Inclusion criteria:

- Histologically confirmed diagnosis of adenocarcinoma of the prostate

- Asymptomatic metastatic CRPC (VAS pain score less than or equal to 3). The patient
may take non-opioid analgesics for non-cancer pain discomfort

- Evidence of metastatic disease from CT or Bone scan

- 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)

- Castrate levels of serum testosterone (less than or equal to 50 ng/dL or 1.7 nmol/L.
Testosterone levels will not be required for patients who have had bilateral
orchiectomy)

- Karnofsky score 70-100

- Laboratory values as follows:

- Hb greater than or equal to 90g/L (greater than or equal to 9g/dL)

- Serum creatinine less than or equal to 1.5 x upper limit of normal (ULN)

- Total bilirubin less than or equal to 1.5 x ULN

- AST (SGOT) / ALT (SGPT) less than or equal to 2.5 x ULN

- Serum amylase less than or equal to ULN. (If serum amylase is greater than ULN,
pancreatic amylase and serum lipase should be analyzed. If both pancreatic
amylase and serum lipase is greater than ULN, exclude patient)

- 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

- No evidence (greater than or equal to 5 years) of prior malignancies (except
successfully treated basal cell, squamous cell carcinoma of the skin)

- Ability to administer and retain oral medication

- Able to adhere to the study visit schedule and other protocol requirements

Exclusion criteria:

- Prior cytotoxic chemotherapy within 3 years

- Previous anti-cancer therapy using biologics or vaccines within the last 6 months.
Previous treatment with bevacizumab is not allowed.

- Any treatment modalities, involving radiation and surgery, not discontinued at least
4 weeks prior to treatment in this study

- Myocardial infarction or any acute coronary syndrome within one year or current
uncontrolled arrhythmias, symptomatic uncontrolled congestive heart failure, unstable
angina pectoris, uncontrolled hypertension

- History of pancreatitis

- 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

- 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]

- Known brain metastases

- 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

- Concomitant systemic treatment with warfarin and/or corticosteroids corresponding to
a prednisolone dose above 5 mg/day

- Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously
or orally within 14 days prior to inclusion

- 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)

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Prostate Cancer

Intervention(s)

Drug: ABR-215050, tasquinimod

Drug: Placebo

Primary Outcome(s)

Disease progression, defined as onset of tumor-related cancer pain, measurable disease progression, bone metastases or other non-target lesions, need for radiotherapy or surgery for pathological fracture or spinal cord compression [Time Frame: 3 months, 6 months; continuation phase every 3 months]

Secondary ID(s)

07TASQ08

EudraCT No: 2007-003470-26

Source(s) of Monetary Support

Please refer to primary and secondary sponsors