Efficacy Study of ABR-215050 to Treat Prostate Cancer

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

To investigate ABR-215050 as a possible treatment for prostate cancer.

Key facts

Study ID

NCT00560482

Run by

Active Biotech AB

People needed

206

Starts

2007-12-01

Expected to finish

2015-08-01

Last updated by the study team

2015-10-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Southern California Permanente Medical Group — Anaheim, California, United States
• Southern California Permanente Medical Group — Baldwin Park, California, United States
• Southern California Permanente Medical Group — Bellflower, California, United States
• Pacific Clinical Center — Beverly Hills, California, United States
• South County Hematology/Oncology — Chula Vista, California, United States
• Southern California Permanente Medical Group — Fontana, California, United States
• Southern California Permanente Medical Group — Irvine, California, United States
• Cancer Center Oncology Medical Group — La Mesa, California, United States
• North County Oncology Medical Clinic, Inc. — Oceanside, California, United States
• San Bernardino Urological Associates — San Bernardino, California, United States
• Urological Physicians of San Diego, Inc. — San Diego, California, United States
• Southern California Permanente Medical Group — San Diego, California, United States
• Medical Oncology Associates - SD — San Diego, California, United States
• Sharp Memorial Hospital Investigational Pharmacy — San Diego, California, United States
• Sharp Rees-Stealy — San Diego, California, United States
• Pacific Clinical Research — Santa Monica, California, United States
• Agajanian Institute of Oncology and Hematology — Whittier, California, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Urology Associates, PC — Denver, Colorado, United States
• Diagnostic Professionals, Inc — Plantation, Florida, United States
• Southeastern Resarch Group, Inc. — Tallahassee, Florida, United States
• Peachtree Hematology-Oncology Consultants — Atlanta, Georgia, United States
• St. Alphonsus Regional Medical Center — Boise, Idaho, United States
• North Idaho Urology — Coeur d'Alene, Idaho, United States
• Alaska Clinical Research Center LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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