Trial record 1 of 2 for:    tasquinimod, prostate cancer, Phase III
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A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Active Biotech AB
ClinicalTrials.gov Identifier:
NCT01234311
First received: November 1, 2010
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Drug: tasquinimod
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Active Biotech AB:

Primary Outcome Measures:
  • A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 1200
Study Start Date: March 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: placebo Drug: tasquinimod
Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
Other Name: ABR-215050

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234311

  Hide Study Locations
Locations
United States, Arizona
Tucson, Arizona, United States
United States, California
Oxnard, California, United States
Santa Monica, California, United States
Santa Rosa, California, United States
United States, Florida
Wellington, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Idaho
Meridian, Idaho, United States
United States, Illinois
Melrose Park, Illinois, United States
Park Ridge, Illinois, United States
United States, Indiana
Jeffersonville, Indiana, United States
United States, Maryland
Baltimore, Maryland, United States
Rockville, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
Jefferson City, Missouri, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Hackensack, New Jersey, United States
Lawrenceville, New Jersey, United States
United States, New York
Buffalo, New York, United States
Poughkeepsie, New York, United States
United States, North Carolina
Concord, North Carolina, United States
Durham, North Carolina, United States
Raleigh, North Carolina, United States
United States, Oregon
Springfield, Oregon, United States
United States, Pennsylvania
Bala Cynwyd, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Myrtle Beach, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
United States, Utah
Salt Lake, Utah, United States
United States, Virginia
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Salem, Virginia, United States
United States, Washington
Burien, Washington, United States
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
Australia, Victoria
Richmond, Victoria, Australia
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
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
Sevilla, Andalucia, Spain
Zaragoza, Aragon, Spain
Oviedo, Asturias, Spain
Santander, Cantabria, Spain
Sabadell, Cataluna, Spain
Alcorcon, Madrid, Communidad de, Spain
Pamplona, Navarra, Spain
Barcelona, Spain
San Sebastian de los Reyes, Spain
Valencia, 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
Sponsors and Collaborators
Active Biotech AB
Investigators
Principal Investigator: Michael A Carducci, MD Johns Hopkins Kimmel Cancer Center, Baltimore, MD
  More Information

No publications provided

Responsible Party: Active Biotech AB
ClinicalTrials.gov Identifier: NCT01234311     History of Changes
Other Study ID Numbers: 10TASQ10
Study First Received: November 1, 2010
Last Updated: May 15, 2014
Health Authority: United States: Food and Drug Administration

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 July 22, 2014