Clinical trial NCT00560482 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: abr-215050, tasquinimod, placebo
SMILES: COC1=CC=CC2=C1C(O)=C(C(=O)N(C)C1=CC=C(C=C1)C(F)(F)F)C(=O)N2C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility 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)