Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over Pharmaceutical / Industry 07TASQ08 EudraCT No: 2007-003470-26, NCT00560482

Trial Description

Summary

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

Further Study Information

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.

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)

Trial Contact Information

Trial Lead Organizations/Sponsors

Active Biotech

Goran Forsberg, Assoc. Prof.

Study Director

Roberto Pili, MD

Principal Investigator

Goran Forsberg, Assoc. Prof.		Ph: +46 46 191154
		Email: goran.forsberg@activebiotech.com

U.S.A.
Alaska
	Anchorage
	Alaska Clinical Research Center, LLC
		William R Clark, MD	Principal Investigator
California
	Beverly Hills
	Pacific Clinical Center
		James Elist, MD	Principal Investigator
	San Diego
	Urological Physicians of San Diego, Incorporated
		Danny L Keiller, MD, CPI	Principal Investigator
	Santa Monica
	Pacific Urological Institute
		Stanley A Brosman, MD	Principal Investigator
	Whittier
	Agajanian Institute of Oncology and Hematology
		Richy Agajanian, MD	Principal Investigator
Colorado
	Denver
	Porter Adventist Hospital
		Barrett Cowan, MD	Principal Investigator
	Urology Associates, PC - Denver
		Barrett Cowan, MD	Principal Investigator
Georgia
	Atlanta
	Peachtree Hematology-Oncology Consultants
		Vasileios J Assikis, MD	Principal Investigator
Idaho
	Boise
	St. Alphonsus Regional Medical Center
		Joseph H Williams, MD	Principal Investigator
	Coeur d'Alene
	North Idaho Urology - Coeur d'Alene
		Randil L Clark, PhD, MD	Principal Investigator
	Meridian
	Idaho Urologic Institute, PA
		Joseph H Williams, MD	Principal Investigator
	Sandpoint
	North Idaho Urology
		Randil L Clark, PhD, MD	Principal Investigator
Illinois
	Chicago
	University of Chicago Cancer Research Center
		Walter M. Stadler	Principal Investigator
	Evanston
	Evanston Northwestern Healthcare - Evanston Hospital
		Daniel H. Shevrin	Principal Investigator
	Galesburg
	Galesburg Cottage Hospital
		Thomas H Patterson, MD	Principal Investigator
	Medical and Surgical Specialists, LLC
		Thomas H Patterson, MD	Principal Investigator
	OSF St Mary Medical Center
		Thomas H Patterson, MD	Principal Investigator
	Peoria
	Specialty Care Research
		Giovanni Colombo, MD	Principal Investigator
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Roberto Pili	Principal Investigator
New Jersey
	Lawrenceville
	AdvanceMed Research
		Russell M Freid, MD	Principal Investigator
New York
	Albany
	Community Care Physicians, PC / The Urological Institute of Northeastern New York
		Hugh AG Fisher, MD	Principal Investigator
	New York
	University Urology Associates
		Jed Kaminetsky, MD	Principal Investigator
	Staten Island
	Staten Island Urological Research, PC
		Ron S Israeli, MD	Principal Investigator
North Carolina
	Durham
	Duke Comprehensive Cancer Center
		Andrew J Armstrong, MD	Principal Investigator
Pennsylvania
	Bala Cynwyd
	Urologic Consultants of SE PA
		Laurence H Belkoff, DO	Principal Investigator
	Bryn Mawr
	Center for Urologic Care of the Main Line
		Guy T Bernstein, MD	Principal Investigator
	Lancaster
	Urological Associates of Lancaster, Limited
		Paul R Sieber, MD	Principal Investigator
	Pittsburgh
	University of Pittsburgh Physicians, Department of Urology
		Jeffrey Gingrich, MD	Principal Investigator
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Sam S Chang, MD	Principal Investigator
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Paul Mathew, MD	Principal Investigator
Washington
	Burien
	Seattle Urology Research Center
		Jeffrey M Frankel, MD	Principal Investigator
Canada
British Columbia
	Surrey
	CMX Research, Incorporated - Surrey
		Cal Andreou	Principal Investigator
	Surrey Memorial Hospital
		Cal Andreou, MD	Principal Investigator
Ontario
	Owen Sound
	2150935 Ontario Inc.
		Todd M Webster, MD	Principal Investigator
	Scarborough
	3030 Lawrence Ave East
		Edward Woods, MD	Principal Investigator
Sweden
	Goteborg
	Sahlgrenska University Hospital
		Jan Erik Damber	Principal Investigator
	Malmo
	University Hospital, Department of Urology
		Goran Ahlgren, MD	Principal Investigator
	Uppsala
	Uppsala University Hospital
		Michael Haggman, MD, PhD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00560482
Information obtained from ClinicalTrials.gov on October 15, 2008