Efficacy Study of ABR-215050 to Treat Prostate Cancer

October 2, 2015 updated by: Active Biotech AB

Phase II Randomized Double Blind Placebo-Controlled Study to Determine the Efficacy of ABR-215050 in Asymptomatic Patients With Metastatic Castrate-Resistant Prostate Cancer

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

206

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
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
Identical appearing gelatin capsules containing placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months, 6 months; continuation phase every 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Goran Forsberg, Assoc. Prof., Active Biotech AB
  • Principal Investigator: Roberto Pili, MD, Roswell Park Cancer Institute, Buffalo, New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 15, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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