A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

October 2, 2015 updated by: Active Biotech AB

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.

Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3 randomized, double blind, placebo controlled study of tasquinimod in asymptomatic to mildly symptomatic patients with metastatic CRPC to confirm the effect of tasquinimod on delaying disease progression compared with placebo.

Approximately 1200 eligible patients with metastatic CRPC will be randomly assigned in a 2:1 ratio to 1 of 2 treatment groups: Treatment Group A (tasquinimod 0.25, 0.5, or 1 mg/day; n=800) or Treatment Group B (placebo; n=400).

Study Type

Interventional

Enrollment (Actual)

1245

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina
      • Santa Rosa, Argentina
      • Venado Tuerto, Argentina
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
      • Coffs Harbour, New South Wales, Australia
      • Darlinghurst, New South Wales, Australia
      • Tweed Heads, New South Wales, Australia
    • Victoria
      • Richmond, Victoria, Australia
    • Western Australia
      • Subiaco, Western Australia, Australia
  • Belgium
      • Bruxelles, Belgium
      • Gent, Belgium
      • Kortrijk, Belgium
      • Liege, Belgium
  • Brazil
      • Botucatu, Sao Paulo, Brazil
      • Cachoeiro de Itapemirim - ES, Brazil
      • Curitiba, Parana, Brazil
      • Florianopolis, Brazil
      • Juiz de Fora, Minas Gerais, Brazil
      • Mogi das Cruzes, Sao Paulo, Brazil
      • Natal, Rio Grande do Norte, Brazil
      • Passo Fundo, Brazil
      • Porto Alegre, RS, Brazil
      • Rio de Janeiro, Brazil
      • Salvador/BA, Brazil
      • Sao Paulo, Brazil
      • Volta Redonda - RJ, Brazil
  • Bulgaria
      • Pleven, Bulgaria
      • Plovdiv, Bulgaria
      • Sofia, Bulgaria
      • Varna, Bulgaria
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • Brantford, Ontario, Canada
      • North York, Ontario, Canada
      • Oakville, Ontario, Canada
  • Chile
      • Santiago, Chile
      • Temuco, Chile
      • Vina del Mar, Chile
  • China
      • Beijing, China
      • Chengdu, China
      • Shanghai, China
      • Shantou, China
      • Wuhan, China
  • Colombia
      • Bogota, Colombia
      • Cali, Colombia
  • Czech Republic
      • Novy Jicin, Czech Republic
      • Olomouc, Czech Republic
      • Praha 2, Czech Republic
      • Praha 5, Czech Republic
      • Usti nad Labem, Czech Republic
  • Estonia
      • Tartu, Estonia
  • France
      • Angers, France
      • Cannes, France
      • Marseille, France
      • Montpellier, France
      • Paris, France
      • Pierre Benite, France
      • Rennes, France
      • Suresnes, France
  • Germany
      • Dresden, Germany
      • Hamburg, Germany
      • Koln, Germany
      • Mannheim, Germany
      • Marburg, Germany
      • Munchen, Germany
      • Munster, Germany
      • Nurtingen, Germany
      • Tubingen, Germany
      • Weiden, Germany
  • Greece
      • Athens, Greece
      • Patras, Greece
      • Thessaloniki, Greece
  • India
      • Pune, India
  • Israel
      • Beer-Sheva, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Petach Tikva, Israel
      • Ramat-Gan, Israel
      • Tel-Aviv, Israel
      • Zerifin, Israel
  • Italy
      • Cremona, Italy
      • Lecco, Italy
      • Meldola, Italy
      • Milano, Italy
      • Padova, Italy
      • Ravenna, Italy
      • Roma, Italy
      • Torino, Italy
  • Korea, Republic of
      • Gwangju, Korea, Republic of
      • Seoul, Korea, Republic of
  • Latvia
      • Liepaja, Latvia
      • Riga, Latvia
  • Lebanon
      • Beirut, Lebanon
      • Bsalim, Lebanon
  • Lithuania
      • Kaunas, Lithuania
      • Vilnius, Lithuania
  • Mexico
      • Chihuahua, Chih., Mexico
      • Culiacan, Sinaloa, Mexico
      • Leon, GTO, Mexico
      • Puebla, Mexico
      • Zapopan, Jalisco, Mexico
  • Netherlands
      • Amsterdam, Netherlands
      • Groningen, Netherlands
      • Leiden, Netherlands
      • Nijmegen, Netherlands
      • Tilburg, Netherlands
  • New Zealand
      • Christchurch, New Zealand
      • Nelson, New Zealand
      • Palmerston North, New Zealand
      • Tauranga, New Zealand
  • Panama
      • Panama, Panama
  • Peru
      • Arequipa, Peru
  • Poland
      • Bialystok, Poland
      • Lodz, Poland
      • Myslowice, Poland
      • Poznan, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • Romania
      • Baia Mare, Romania
      • Bucharest, Romania
      • Cluj-Napoca, Romania
      • Craiova, Romania
      • Ploiesti, Romania
      • Suceava, Romania
      • Timisoara, Romania
  • Russian Federation
      • Ekaterinburg, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Omsk, Russian Federation
      • St. Petersburg, Russian Federation
      • Vladimir, Russian Federation
  • Slovakia
      • Bratislava, Slovakia
      • Trencin, Slovakia
  • Spain
      • Barcelona, Spain
      • San Sebastian de los Reyes, Spain
      • Valencia, Spain
    • Andalucia
      • Sevilla, Andalucia, Spain
    • Aragon
      • Zaragoza, Aragon, Spain
    • Asturias
      • Oviedo, Asturias, Spain
    • Cantabria
      • Santander, Cantabria, Spain
    • Cataluna
      • Sabadell, Cataluna, Spain
    • Madrid, Communidad de
      • Alcorcon, Madrid, Communidad de, Spain
    • Navarra
      • Pamplona, Navarra, Spain
  • Sweden
      • Göteborg, Sweden
      • Karlstad, Sweden
      • Stockholm, Sweden
  • Taiwan
      • Kaohsiung, Taiwan
      • Taichung, Taiwan
      • Taipei, Taiwan
      • Taoyuan, Taiwan
  • Turkey
      • Istanbul, Turkey
  • Ukraine
      • Chernivtsi, Ukraine
      • Dnipropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kharkiv, Ukraine
      • Kyiv, Ukraine
      • Lutsk, Ukraine
      • Lviv, Ukraine
      • Odesa, Ukraine
      • Uzhgorod, Ukraine
      • Zaporizhzhya, Ukraine
  • United Kingdom
      • Birmingham, United Kingdom
      • Chichester, United Kingdom
      • Leeds, United Kingdom
      • London, United Kingdom
      • Northwood, United Kingdom
      • Nottingham, United Kingdom
      • Oxford, United Kingdom
      • Scunthorpe, United Kingdom
      • Sutton, United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Oxnard, California, United States
      • Santa Monica, California, United States
      • Santa Rosa, California, United States
    • Florida
      • Wellington, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Idaho
      • Meridian, Idaho, United States
    • Illinois
      • Melrose Park, Illinois, United States
      • Park Ridge, Illinois, United States
    • Indiana
      • Jeffersonville, Indiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Rockville, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Missouri
      • Jefferson City, Missouri, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Hackensack, New Jersey, United States
      • Lawrenceville, New Jersey, United States
    • New York
      • Buffalo, New York, United States
      • Poughkeepsie, New York, United States
    • North Carolina
      • Concord, North Carolina, United States
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Oregon
      • Springfield, Oregon, United States
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States
      • Lancaster, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • South Carolina
      • Myrtle Beach, South Carolina, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
    • Utah
      • Salt Lake, Utah, United States
    • Virginia
      • Fairfax, Virginia, United States
      • Norfolk, Virginia, United States
      • Salem, Virginia, United States
    • Washington
      • Burien, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Age at least 18 years at the time of signing the informed consent form. For patients in Taiwan the minimum age is 20 years.
  2. Histologically confirmed diagnosis of adenocarcinoma of the prostate.
  3. Evidence of bone metastatic disease on radiographic examination, whether from bone scan or other imaging modality.
  4. Castrate levels of serum testosterone (≤50 ng/dL or 1.7 nmol/L).
  5. Evidence of progressive disease.
  6. Karnofsky score ≥70%.
  7. Meet screening laboratory values as specified in thr protocol.
  8. If sexually active with partner of childbearing potential, patient will agree to use adequate contraceptive methods (barrier contraceptive with spermicide or vasectomy) while on study drug. The adequate contraceptive method should be continued for 14 days after the patient stops taking study drug.
  9. No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).
  10. Able to swallow and retain oral medication.
  11. Able to adhere to the study visit schedule and other protocol requirements.
  12. Ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the investigator and to comply with the requirements of the entire study.
  13. Able (or patient's legal guardian, if applicable) to sign and date the written informed consent after being informed of the full nature and purpose of the study, including possible risks and side effects, and given ample time and opportunity to read and understand this information.

Exclusion Criteria:

  1. Prior cytotoxic chemotherapy for the treatment of prostate ca within 2 years or within 4 weeks for Estracyt (estramustine) prior to study treatment.
  2. Previous anticancer therapy using radiation, biologics or vaccines, including abiraterone, TAK-700 (Orteronel), or MDV3100 within 4 weeks prior or sipuleucel-T (Provenge) within 2 weeks prior to the start of study treatment. If radiation therapy is applied after baseline scan, a new baseline scan needs to be done at least 4 weeks after the radiation therapy.
  3. Previous therapy with antiandrogens within 4 weeks (within 6 weeks for bicalutamide eg, Casodex®) prior to study treatment.

  4. Concurrent use of other anticancer agents or treatments, with the following exceptions:

    • Ongoing treatment with luteinizing hormone-releasing hormone agonists or antagonists, denosumab (Prolia) or bisphosphonate (eg, zoledronic acid) is allowed. Ongoing treatment should be kept at a stable schedule; however, if medically required, a change of dose, compound, or both is allowed.

  5. Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.
  6. Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.
  7. Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 (Section 4.6.8.1).
  8. Maintenance treatment with corticosteroids corresponding to a prednisolone or prednisone dose above 10 mg/day. The dose must have been stable for at least 5 days.
  9. Systemic exposure to ketoconazole or other strong cytochrome P450 (CYP) 3A4 isozyme inhibitors or inducers within 14 days prior to the start of study treatment. Systemic exposure to amiodarone is not allowed within 1 year prior to the start of study treatment.
  10. Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.
  11. Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.
  12. Simultaneous participation in any other study involving treatment with investigational drugs or having received treatment with investigational drugs less than 4 weeks prior to the start of study treatment.
  13. Myocardial infarction, percutaneous coronary intervention, acute coronary syndrome, coronary artery bypass graft, class III/IV congestive heart failure, cerebrovascular accident, transient ischemic attack, or limb claudication at rest, within 6 months prior to start of study treatment and ongoing symptomatic dysrhythmias, unstable angina, uncontrolled hypertension, and uncontrolled atrial or ventricular arrhythmias.
  14. History of pancreatitis.
  15. Known brain or epidural metastases.
  16. 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).
  17. Chronic hepatitis with advanced, decompensated hepatic disease or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients who have recovered from hepatitis will be allowed to enter the study).
  18. Patients with active tuberculosis (TB), or with known, untreated latent TB. (Country-specific TB therapy should have been given for at least 30 days prior to the start of study treatment and the patient should intend to complete the entire course of that therapy.)
  19. Any condition, including other active or latent infections, medical or psychiatric conditions, or the presence of laboratory abnormalities, which could confound the ability to interpret data from the study or places the patient at unacceptable risk if he participates in the study.
  20. Any patient who in the opinion of the investigator should not participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Matching placebo
Drug: Placebo
Experimental: tasquinimod
Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
Drug: tasquinimod
Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
Other Names:
  • ABR-215050

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer
Time Frame: 5 years
The primary endpoint is progression-free survival (PFS) defined as the time from the date of randomization to the date of radiological progression or death.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Active Biotech AB

Investigators

  • Principal Investigator: Michael A Carducci, MD, Johns Hopkins Kimmel Cancer Center, Baltimore, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 3, 2010

First Posted (Estimate)

November 4, 2010

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

October 2, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10TASQ10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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