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Prostate CancerPhase 2NCT00560482

Efficacy Study of ABR-215050 to Treat Prostate Cancer

A Phase 2 study testing ABR-215050, tasquinimod in people with Prostate Cancer, run by Active Biotech AB at 65 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To investigate ABR-215050 as a possible treatment for prostate cancer. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
ABR-215050, tasquinimod
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
206 participants
Where
65 sitesin 3 countries
Study dates
Dec 2007to Aug 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

65 sites in 3 countries.

65 sites in 3 countries

United States54 sites

  • Community Care Physicians, PC / The Urological Institute of Northeastern New York

    Albany, New York, 12208

  • Urology Group of New Mexico

    Albuquerque, New Mexico, 87109

  • Southern California Permanente Medical Group

    Anaheim, California, 92807

  • Alaska Clinical Research Center LLC

    Anchorage, Alaska, 99508

  • Peachtree Hematology-Oncology Consultants

    Atlanta, Georgia, 30309

  • Urologic Consultants of SE PA

    Bala-Cynwyd, Pennsylvania, 19004

  • Southern California Permanente Medical Group

    Baldwin Park, California, 91706

  • Johns Hopkins

    Baltimore, Maryland, 21231

  • Southern California Permanente Medical Group

    Bellflower, California, 90706

  • Pacific Clinical Center

    Beverly Hills, California, 90211

  • St. Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Center for Urologic Care of the Main Line

    Bryn Mawr, Pennsylvania, 19010

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Seattle Urology Research Center

    Burien, Washington, 98166

  • University of Chicago

    Chicago, Illinois, 60637

  • South County Hematology/Oncology

    Chula Vista, California, 91911

  • North Idaho Urology

    Coeur d'Alene, Idaho, 83814

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Urology Associates, PC

    Denver, Colorado, 80210

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Evanston Northwestern Healthcare

    Evanston, Illinois, 60201

  • Southern California Permanente Medical Group

    Fontana, California, 92335

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Medical and Surgical Specialists

    Galesburg, Illinois, 61401

  • OSF St Mary Medical Center

    Galesburg, Illinois, 61401

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • Southern California Permanente Medical Group

    Irvine, California, 92618

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania, 17604-3200

  • AdvanceMed Research

    Lawrenceville, New Jersey, 08648

  • Midwest Urology/RMD Clinical Research Institute

    Melrose Park, Illinois, 60160

  • Idaho Urologic Institute, PA

    Meridian, Idaho, 83642

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2765

  • Beth Israel Medical Center

    New York, New York, 10003

  • University Urological Associates

    New York, New York, 10016

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • North County Oncology Medical Clinic, Inc.

    Oceanside, California, 92056

  • University of Pittsburgh Physicians, Department of Urology

    Pittsburgh, Pennsylvania, 15232

  • Diagnostic Professionals, Inc

    Plantation, Florida, 33317

  • Wake Urological Associates

    Raleigh, North Carolina, 27607

  • San Bernardino Urological Associates

    San Bernardino, California, 92404

  • Urological Physicians of San Diego, Inc.

    San Diego, California, 92103

  • Southern California Permanente Medical Group

    San Diego, California, 92120

  • Medical Oncology Associates - SD

    San Diego, California, 92123

  • Sharp Memorial Hospital Investigational Pharmacy

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • North Idaho Urology

    Sandpoint, Idaho, 83864

  • Pacific Clinical Research

    Santa Monica, California, 90404

  • Roger D. Fincher, M.D., P.S.

    Spokane, Washington, 99204

  • Staten Island Urological Research, PC

    Staten Island, New York, 10304

  • Southeastern Resarch Group, Inc.

    Tallahassee, Florida, 32308

  • Agajanian Institute of Oncology and Hematology

    Whittier, California, 90602

Other trials in United States

Canada8 sites

  • Guelph General Hospital

    Guelph, Ontario, N1E4J4

  • Guelph Nuclear Imaging

    Guelph, Ontario, N1H1B1

  • Guelph Urology Associates

    Guelph, Ontario, N1H5J1

  • Office of Dr. Bernard Goldfarb

    North Bay, Ontario, P1B 7K8

  • 2150935 Ontario Inc.

    Owen Sound, Ontario, N4K 2J1

  • 3030 Lawrence Ave East

    Scarborough Village, Ontario, M1P 2T7

  • Andreou Research

    Surrey, British Columbia, V3V 1N1

  • Surrey Memorial Hospital

    Surrey, British Columbia, V3V 1Z2

Other trials in Canada

Sweden3 sites

  • Institute of Clinical Sciences, Dept. of Urology / Sahlgrenska University Hospital

    Gothenburg, SE-41345

  • University Hospital, Department of Urology

    Malmö

  • Dept. of Urology, Akademiska Sjukhuset

    Uppsala, SE-75185

Other trials in Sweden

About this study

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

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

Read the 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.

Conditions
Prostate Cancer
Being tested
ABR-215050, tasquinimod, Placebo
Keywords
prostate, cancer, prostatic cancer, castrate-resistant prostate cancer (CRPC)
Medical subject headings
Prostatic Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ABR-215050, tasquinimodDrug

    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)

  • PlaceboDrug

    Identical appearing gelatin capsules containing placebo

Study groups in NCT00560482
Study groupRoleWhat they receive
AActive comparatorNot described
Receives: Drug: ABR-215050, tasquinimod
BPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months, 6 months; continuation phase every 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionJun 2010
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00560482
Sponsor's protocol ID
07TASQ08
Other IDs
EudraCT No: 2007-003470-26
Status last verified
Oct 2015
First submitted
15 Nov 2007
Last updated
26 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21931019

  • 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.

    PubMed 24255071

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABR-215050, tasquinimod in people with Prostate Cancer, run by Active Biotech AB at 65 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: 3 months, 6 months; continuation phase every 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00560482, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2015.

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