Efficacy Study of ABR-215050 to Treat Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Active Biotech AB.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Active Biotech AB
ClinicalTrials.gov Identifier:
NCT00560482
First received: November 15, 2007
Last updated: December 22, 2011
Last verified: December 2011
  Purpose

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


Condition Intervention Phase
Prostate Cancer
Drug: ABR-215050, tasquinimod
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Active Biotech AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 206
Study Start Date: December 2007
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A 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 Comparator: B Drug: Placebo
Identical appearing gelatin capsules containing placebo

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00560482

  Show 65 Study Locations
Sponsors and Collaborators
Active Biotech AB
Investigators
Study Director: Goran Forsberg, Assoc. Prof. Active Biotech AB
Principal Investigator: Roberto Pili, MD Roswell Park Cancer Institute, Buffalo, New York
  More Information

No publications provided

Responsible Party: Active Biotech AB
ClinicalTrials.gov Identifier: NCT00560482     History of Changes
Other Study ID Numbers: 07TASQ08, EudraCT No: 2007-003470-26
Study First Received: November 15, 2007
Last Updated: December 22, 2011
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency

Keywords provided by Active Biotech AB:
prostate
cancer
prostatic cancer
castrate-resistant prostate cancer (CRPC)

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014