Clinical trial NCT00560482: Efficacy Study of ABR-215050 to Treat Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate
cancer
prostatic cancer
castrate-resistant prostate cancer (CRPC)
Lead sponsor: Active Biotech AB
Sponsor class: INDUSTRY
First posted: 2007-11-19
Enrollment: 206
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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)

Primary outcomes:
measure: 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
timeFrame: 3 months, 6 months; continuation phase every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Clinical Research Center LLC
state: Alaska
city: Anaheim
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Baldwin Park
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Bellflower
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Beverly Hills
country: United States
facility: Pacific Clinical Center
state: California
city: Chula Vista
country: United States
facility: South County Hematology/Oncology
state: California
city: Fontana
country: United States
facility: Southern California Permanente Medical Group
state: California
city: Irvine
country: United States
facility: Southern California Permanente Medical Group
state: California
city: La Mesa
country: United States
facility: Cancer Center Oncology Medical Group
state: California
city: Oceanside
country: United States
facility: North County Oncology Medical Clinic, Inc.
state: California
city: San Bernardino
country: United States
facility: San Bernardino Urological Associates
state: California
city: San Diego
country: United States
facility: Urological Physicians of San Diego, Inc.
state: California
city: San Diego
country: United States
facility: Southern California Permanente Medical Group
state: California
city: San Diego
country: United States
facility: Medical Oncology Associates - SD
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital Investigational Pharmacy
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: Santa Monica
country: United States
facility: Pacific Clinical Research
state: California
city: Whittier
country: United States
facility: Agajanian Institute of Oncology and Hematology
state: California
city: Denver
country: United States
facility: Porter Adventist Hospital
state: Colorado
city: Denver
country: United States
facility: Urology Associates, PC
state: Colorado
city: Plantation
country: United States
facility: Diagnostic Professionals, Inc
state: Florida
city: Tallahassee
country: United States
facility: Southeastern Resarch Group, Inc.
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology-Oncology Consultants
state: Georgia
city: Boise
country: United States
facility: St. Alphonsus Regional Medical Center
state: Idaho
city: Coeur d'Alene
country: United States
facility: North Idaho Urology
state: Idaho
city: Meridian
country: United States
facility: Idaho Urologic Institute, PA
state: Idaho
city: Sandpoint
country: United States
facility: North Idaho Urology
state: Idaho
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Galesburg
country: United States
facility: Galesburg Cottage Hospital
state: Illinois
city: Galesburg
country: United States
facility: Medical and Surgical Specialists
state: Illinois
city: Galesburg
country: United States
facility: OSF St Mary Medical Center
state: Illinois
city: Melrose Park
country: United States
facility: Midwest Urology/RMD Clinical Research Institute
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Lawrenceville
country: United States
facility: AdvanceMed Research
state: New Jersey
city: Albuquerque
country: United States
facility: Urology Group of New Mexico
state: New Mexico
city: Albany
country: United States
facility: Community Care Physicians, PC / The Urological Institute of Northeastern New York
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Beth Israel Medical Center
state: New York
city: New York
country: United States
facility: University Urological Associates
state: New York
city: Staten Island
country: United States
facility: Staten Island Urological Research, PC
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Urological Associates
state: North Carolina
city: Bala Cynwyd
country: United States
facility: Urologic Consultants of SE PA
state: Pennsylvania
city: Bryn Mawr
country: United States
facility: Center for Urologic Care of the Main Line
state: Pennsylvania
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Physicians, Department of Urology
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Burien
country: United States
facility: Seattle Urology Research Center
state: Washington
city: Spokane
country: United States
facility: Roger D. Fincher, M.D., P.S.
state: Washington
city: Surrey
country: Canada
facility: Andreou Research
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Guelph
country: Canada
facility: Guelph General Hospital
state: Ontario
city: Guelph
country: Canada
facility: Guelph Nuclear Imaging
state: Ontario
city: Guelph
country: Canada
facility: Guelph Urology Associates
state: Ontario
city: North Bay
country: Canada
facility: Office of Dr. Bernard Goldfarb
state: Ontario
city: Owen Sound
country: Canada
facility: 2150935 Ontario Inc.
state: Ontario
city: Scarborough
country: Canada
facility: 3030 Lawrence Ave East
state: Ontario
city: Goteborg
country: Sweden
facility: Institute of Clinical Sciences, Dept. of Urology / Sahlgrenska University Hospital
city: Malmo
country: Sweden
facility: University Hospital, Department of Urology
city: Uppsala
country: Sweden
facility: Dept. of Urology, Akademiska Sjukhuset
Study officials:
affiliation: Active Biotech AB
name: Goran Forsberg, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Roswell Park Cancer Institute, Buffalo, New York
name: Roberto Pili, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Armstrong 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.