Efficacy Study of ABR-215050 to Treat Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Active Biotech AB
ClinicalTrials.gov Identifier:
NCT00560482
First received: November 15, 2007
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: ABR-215050, tasquinimod
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Active Biotech AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: December 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: ABR-215050, tasquinimod
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)
Placebo Comparator: B Drug: Placebo
Identical appearing gelatin capsules containing placebo

Detailed Description:

For asymptomatic patients with Castrate-Resistant Prostate Cancer (CRPC), a "window of opportunity" is present. During this "window of opportunity" an intervention with little or no toxicity and the potential for extending the "symptom-free" period would be of great value to keep metastatic patients in an asymptomatic stage and thus delay the introduction of chemotherapy. The purpose of this study is to evaluate the safety and efficacy of ABR-215050 as an interventional agent for this role.

Overall survival for patients participating in study 07TASQ08 will be evaluated retrospectively using a separate study protocol 11TASQ11.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00560482

  Hide Study Locations
Locations
United States, Alaska
Alaska Clinical Research Center LLC
Anchorage, Alaska, United States, 99508
United States, California
Southern California Permanente Medical Group
Anaheim, California, United States, 92807
Southern California Permanente Medical Group
Baldwin Park, California, United States, 91706
Southern California Permanente Medical Group
Bellflower, California, United States, 90706
Pacific Clinical Center
Beverly Hills, California, United States, 90211
South County Hematology/Oncology
Chula Vista, California, United States, 91911
Southern California Permanente Medical Group
Fontana, California, United States, 92335
Southern California Permanente Medical Group
Irvine, California, United States, 92618
Cancer Center Oncology Medical Group
La Mesa, California, United States, 91942
North County Oncology Medical Clinic, Inc.
Oceanside, California, United States, 92056
San Bernardino Urological Associates
San Bernardino, California, United States, 92404
Urological Physicians of San Diego, Inc.
San Diego, California, United States, 92103
Southern California Permanente Medical Group
San Diego, California, United States, 92120
Sharp Rees-Stealy
San Diego, California, United States, 92123
Medical Oncology Associates - SD
San Diego, California, United States, 92123
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, United States, 92123
Pacific Clinical Research
Santa Monica, California, United States, 90404
Agajanian Institute of Oncology and Hematology
Whittier, California, United States, 90602
United States, Colorado
Urology Associates, PC
Denver, Colorado, United States, 80210
Porter Adventist Hospital
Denver, Colorado, United States, 80210
United States, Florida
Diagnostic Professionals, Inc
Plantation, Florida, United States, 33317
Southeastern Resarch Group, Inc.
Tallahassee, Florida, United States, 32308
United States, Georgia
Peachtree Hematology-Oncology Consultants
Atlanta, Georgia, United States, 30309
United States, Idaho
St. Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
North Idaho Urology
Coeur d'Alene, Idaho, United States, 83814
Idaho Urologic Institute, PA
Meridian, Idaho, United States, 83642
North Idaho Urology
Sandpoint, Idaho, United States, 83864
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
OSF St Mary Medical Center
Galesburg, Illinois, United States, 61401
Medical and Surgical Specialists
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Midwest Urology/RMD Clinical Research Institute
Melrose Park, Illinois, United States, 60160
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21231
United States, New Jersey
AdvanceMed Research
Lawrenceville, New Jersey, United States, 08648
United States, New Mexico
Urology Group of New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
Community Care Physicians, PC / The Urological Institute of Northeastern New York
Albany, New York, United States, 12208
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
University Urological Associates
New York, New York, United States, 10016
Beth Israel Medical Center
New York, New York, United States, 10003
Staten Island Urological Research, PC
Staten Island, New York, United States, 10304
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Urological Associates
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
Urologic Consultants of SE PA
Bala Cynwyd, Pennsylvania, United States, 19004
Center for Urologic Care of the Main Line
Bryn Mawr, Pennsylvania, United States, 19010
Urological Associates of Lancaster
Lancaster, Pennsylvania, United States, 17604-3200
University of Pittsburgh Physicians, Department of Urology
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2765
United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Virginia Oncology Associates
Hampton, Virginia, United States, 23666
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
United States, Washington
Seattle Urology Research Center
Burien, Washington, United States, 98166
Roger D. Fincher, M.D., P.S.
Spokane, Washington, United States, 99204
Canada, British Columbia
Andreou Research
Surrey, British Columbia, Canada, V3V 1N1
Surrey Memorial Hospital
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Ontario
Guelph Urology Associates
Guelph, Ontario, Canada, N1H5J1
Guelph Nuclear Imaging
Guelph, Ontario, Canada, N1H1B1
Guelph General Hospital
Guelph, Ontario, Canada, N1E4J4
Office of Dr. Bernard Goldfarb
North Bay, Ontario, Canada, P1B 7K8
2150935 Ontario Inc.
Owen Sound, Ontario, Canada, N4K 2J1
3030 Lawrence Ave East
Scarborough, Ontario, Canada, M1P 2T7
Sweden
Institute of Clinical Sciences, Dept. of Urology / Sahlgrenska University Hospital
Goteborg, Sweden, SE-41345
University Hospital, Department of Urology
Malmo, Sweden
Dept. of Urology, Akademiska Sjukhuset
Uppsala, Sweden, SE-75185
Sponsors and Collaborators
Active Biotech AB
Investigators
Study Director: Goran Forsberg, Assoc. Prof. Active Biotech AB
Principal Investigator: Roberto Pili, MD Roswell Park Cancer Institute, Buffalo, New York
  More Information

Publications:
Responsible Party: Active Biotech AB
ClinicalTrials.gov Identifier: NCT00560482     History of Changes
Other Study ID Numbers: 07TASQ08, EudraCT No: 2007-003470-26
Study First Received: November 15, 2007
Last Updated: June 17, 2014
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency

Keywords provided by Active Biotech AB:
prostate
cancer
prostatic cancer
castrate-resistant prostate cancer (CRPC)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 29, 2014