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

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

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

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.

Inclusion 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

- 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

- 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

- 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

- 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)

Type of Study:


Study Design:

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

Outcome 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

Outcome Time Frame:

3 months, 6 months; continuation phase every 3 months

Safety Issue:


Principal Investigator

Goran Forsberg, Assoc. Prof.

Investigator Role:

Study Director

Investigator Affiliation:

Active Biotech AB


United States: Food and Drug Administration

Study ID:




Start Date:

December 2007

Completion Date:

July 2012

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • prostatic cancer
  • castrate-resistant prostate cancer (CRPC)
  • Prostatic Neoplasms



Roswell Park Cancer Institute Buffalo, New York  14263
Porter Adventist Hospital Denver, Colorado  80210
Beth Israel Medical Center New York, New York  10003
Southern California Permanente Medical Group Downey, California  90242
Virginia Oncology Associates Newport News, Virginia  23606
Galesburg Cottage Hospital Galesburg, Illinois  61401
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Evanston Northwestern Healthcare Evanston, Illinois  60201
Wake Urological Associates Raleigh, North Carolina  27607
Duke University Medical Center Durham, North Carolina  27710
North Idaho Urology Couer D'Alene, Idaho  83814
Pacific Clinical Research Santa Monica, California  90404
M.D. Anderson Cancer Center Houston, Texas  77030
University of Chicago Chicago, Illinois  60637
Urological Associates Of Lancaster Lancaster, Pennsylvania  17604-3200
San Bernardino Urological Associates San Bernardino, California  
Pacific Clinical Center Encino, California  91316
Sharp Rees-Stealy La Mesa, California  91942
Staten Island Urological Research, PC Staten Island, New York  10304
Medical and Surgical Specialists Galesburg, Illinois  61401
Urology Group of New Mexico Albuquerque, New Mexico  87109
Johns Hopkins Baltimore, Maryland  21231
Medical Oncology Associates - SD San Diego, California  92123
Cancer Center Oncology Medical Group La Mesa, California  91942
Seattle Urology Research Center Burien, Washington  
AdvanceMed Research Lawrenceville, New Jersey  08648
Alaska Clinical Research Center LLC Anchorage, Alaska  99508
South County Hematology/Oncology Chula Vista, California  91911
North County Oncology Medical Clinic, Inc. Oceanside, California  92056
Urological Physicians of San Diego, Inc. San Diego, California  92103
Sharp Memorial Hospital Investigational Pharmacy San Diego, California  92123
Agajanian Institute of Oncology and Hematology Whittier, California  90602
Urology Associates, PC Denver, Colorado  80210
Diagnostic Professionals, Inc Plantation, Florida  33317
Southeastern Resarch Group, Inc. Tallahassee, Florida  32308
Peachtree Hematology-Oncology Consultants Atlanta, Georgia  30309
St. Alphonsus Regional Medical Center Boise, Idaho  83706
Idaho Urologic Institute, PA Meridian, Idaho  83642
OSF St Mary Medical Center Galesburg, Illinois  61401
Midwest Urology/RMD Clinical Research Institute Melrose Park, Illinois  60160
Community Care Physicians, PC / The Urological Institute of Northeastern New York Albany, New York  12208
University Urological Associates New York, New York  10016
Urologic Consultants of SE PA Bala Cynwyd, Pennsylvania  19004
Center for Urologic Care of the Main Line Bryn Mawr, Pennsylvania  19010
University of Pittsburgh Physicians, Department of Urology Pittsburgh, Pennsylvania  15232
Roger D. Fincher, M.D., P.S. Spokane, Washington  99204