Efficacy Study of ABR-215050 to Treat Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560482
• Other study ID #: 07TASQ08
• Secondary ID: EudraCT No: 2007
• Status: Completed
• Phase: Phase 2
• First received: November 15, 2007
• Last updated: October 2, 2015
• Start date: December 2007
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Active Biotech AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: August 2015
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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
Identical appearing gelatin capsules containing placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Active Biotech AB

Countries where clinical trial is conducted

United States,  Canada,  Sweden, 

References & Publications (2)

Armstrong AJ, Häggman M, Stadler WM, Gingrich JR, Assikis V, Polikoff J, Damber JE, Belkoff L, Nordle Ö, Forsberg G, Carducci MA, Pili R. Long-term survival and biomarker correlates of tasquinimod efficacy in a multicenter randomized study of men with min — View Citation

Pili R, Häggman M, Stadler WM, Gingrich JR, Assikis VJ, Björk 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 pr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No