Efficacy Study of ABR-215050 to Treat Prostate Cancer
Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer
2 other identifiers
interventional
206
3 countries
65
Brief Summary
To investigate ABR-215050 as a possible treatment for prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Dec 2007
Longer than P75 for phase_2 prostate-cancer
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2007
CompletedFirst Posted
Study publicly available on registry
November 19, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedOctober 26, 2015
October 1, 2015
2.5 years
November 15, 2007
October 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 months, 6 months; continuation phase every 3 months
Study Arms (2)
A
ACTIVE COMPARATORB
PLACEBO COMPARATORInterventions
Gelatin capsules containing 0.25mg, 0.50mg, 1.0mg ABR-215050; 0.25mg/day taken orally once daily for 2 weeks, 0.50mg/day taken orally once daily for 2 weeks (dose-titration), and 1.0 mg/day taken once daily for 5 months (+6 months continuation)
Eligibility Criteria
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)
- +4 more criteria
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
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Alaska Clinical Research Center LLC
Anchorage, Alaska, 99508, United States
Southern California Permanente Medical Group
Anaheim, California, 92807, United States
Southern California Permanente Medical Group
Baldwin Park, California, 91706, United States
Southern California Permanente Medical Group
Bellflower, California, 90706, United States
Pacific Clinical Center
Beverly Hills, California, 90211, United States
South County Hematology/Oncology
Chula Vista, California, 91911, United States
Southern California Permanente Medical Group
Fontana, California, 92335, United States
Southern California Permanente Medical Group
Irvine, California, 92618, United States
Cancer Center Oncology Medical Group
La Mesa, California, 91942, United States
North County Oncology Medical Clinic, Inc.
Oceanside, California, 92056, United States
San Bernardino Urological Associates
San Bernardino, California, 92404, United States
Urological Physicians of San Diego, Inc.
San Diego, California, 92103, United States
Southern California Permanente Medical Group
San Diego, California, 92120, United States
Medical Oncology Associates - SD
San Diego, California, 92123, United States
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, 92123, United States
Sharp Rees-Stealy
San Diego, California, 92123, United States
Pacific Clinical Research
Santa Monica, California, 90404, United States
Agajanian Institute of Oncology and Hematology
Whittier, California, 90602, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Urology Associates, PC
Denver, Colorado, 80210, United States
Diagnostic Professionals, Inc
Plantation, Florida, 33317, United States
Southeastern Resarch Group, Inc.
Tallahassee, Florida, 32308, United States
Peachtree Hematology-Oncology Consultants
Atlanta, Georgia, 30309, United States
St. Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
North Idaho Urology
Coeur d'Alene, Idaho, 83814, United States
Idaho Urologic Institute, PA
Meridian, Idaho, 83642, United States
North Idaho Urology
Sandpoint, Idaho, 83864, United States
University of Chicago
Chicago, Illinois, 60637, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Medical and Surgical Specialists
Galesburg, Illinois, 61401, United States
OSF St Mary Medical Center
Galesburg, Illinois, 61401, United States
Midwest Urology/RMD Clinical Research Institute
Melrose Park, Illinois, 60160, United States
Johns Hopkins
Baltimore, Maryland, 21231, United States
AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Urology Group of New Mexico
Albuquerque, New Mexico, 87109, United States
Community Care Physicians, PC / The Urological Institute of Northeastern New York
Albany, New York, 12208, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Beth Israel Medical Center
New York, New York, 10003, United States
University Urological Associates
New York, New York, 10016, United States
Staten Island Urological Research, PC
Staten Island, New York, 10304, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Wake Urological Associates
Raleigh, North Carolina, 27607, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004, United States
Center for Urologic Care of the Main Line
Bryn Mawr, Pennsylvania, 19010, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604-3200, United States
University of Pittsburgh Physicians, Department of Urology
Pittsburgh, Pennsylvania, 15232, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2765, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Seattle Urology Research Center
Burien, Washington, 98166, United States
Roger D. Fincher, M.D., P.S.
Spokane, Washington, 99204, United States
Andreou Research
Surrey, British Columbia, V3V 1N1, Canada
Surrey Memorial Hospital
Surrey, British Columbia, V3V 1Z2, Canada
Guelph General Hospital
Guelph, Ontario, N1E4J4, Canada
Guelph Nuclear Imaging
Guelph, Ontario, N1H1B1, Canada
Guelph Urology Associates
Guelph, Ontario, N1H5J1, Canada
Office of Dr. Bernard Goldfarb
North Bay, Ontario, P1B 7K8, Canada
2150935 Ontario Inc.
Owen Sound, Ontario, N4K 2J1, Canada
3030 Lawrence Ave East
Scarborough Village, Ontario, M1P 2T7, Canada
Institute of Clinical Sciences, Dept. of Urology / Sahlgrenska University Hospital
Gothenburg, SE-41345, Sweden
University Hospital, Department of Urology
Malmo, Sweden
Dept. of Urology, Akademiska Sjukhuset
Uppsala, SE-75185, Sweden
Related Publications (2)
Pili R, Haggman M, Stadler WM, Gingrich JR, Assikis VJ, Bjork A, Nordle O, Forsberg G, Carducci MA, Armstrong AJ. Phase II randomized, double-blind, placebo-controlled study of tasquinimod in men with minimally symptomatic metastatic castrate-resistant prostate cancer. J Clin Oncol. 2011 Oct 20;29(30):4022-8. doi: 10.1200/JCO.2011.35.6295. Epub 2011 Sep 19.
PMID: 21931019RESULTArmstrong AJ, Haggman M, Stadler WM, Gingrich JR, Assikis V, Polikoff J, Damber JE, Belkoff L, Nordle O, Forsberg G, Carducci MA, Pili R. Long-term survival and biomarker correlates of tasquinimod efficacy in a multicenter randomized study of men with minimally symptomatic metastatic castration-resistant prostate cancer. Clin Cancer Res. 2013 Dec 15;19(24):6891-901. doi: 10.1158/1078-0432.CCR-13-1581. Epub 2013 Nov 19.
PMID: 24255071RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Goran Forsberg, Assoc. Prof.
Active Biotech AB
- PRINCIPAL INVESTIGATOR
Roberto Pili, MD
Roswell Park Cancer Institute, Buffalo, New York
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2007
First Posted
November 19, 2007
Study Start
December 1, 2007
Primary Completion
June 1, 2010
Study Completion
August 1, 2015
Last Updated
October 26, 2015
Record last verified: 2015-10