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

Sponsor
Active Biotech AB (Industry)
Overall Status
Completed
CT.gov ID
NCT01234311
Collaborator
(none)
1,245
Enrollment
205
Locations
2
Arms
53
Duration (Months)
6.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
1245 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Feb 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    1. Any treatment modalities involving major surgery within 4 weeks prior to the start of study treatment.

    2. Prostate ca pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy.

    3. Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4 (Section 4.6.8.1).

    4. 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.

    5. 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.

    6. Ongoing treatment with sensitive CYP1A2 substrate or CYP1A2 substrate with narrow therapeutic range at the start of study treatment.

    7. Ongoing treatment with CYP3A4 substrate with narrow therapeutic range at the start of study treatment.

    8. 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.

    9. 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.

    10. History of pancreatitis.

    11. Known brain or epidural metastases.

    12. 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).

    13. 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).

    14. 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.)

    15. 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.

    16. Any patient who in the opinion of the investigator should not participate

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tucson Arizona United States
    2 Oxnard California United States
    3 Santa Monica California United States
    4 Santa Rosa California United States
    5 Wellington Florida United States
    6 Atlanta Georgia United States
    7 Meridian Idaho United States
    8 Melrose Park Illinois United States
    9 Park Ridge Illinois United States
    10 Jeffersonville Indiana United States
    11 Baltimore Maryland United States
    12 Rockville Maryland United States
    13 Boston Massachusetts United States
    14 Jefferson City Missouri United States
    15 Las Vegas Nevada United States
    16 Hackensack New Jersey United States
    17 Lawrenceville New Jersey United States
    18 Buffalo New York United States
    19 Poughkeepsie New York United States
    20 Concord North Carolina United States
    21 Durham North Carolina United States
    22 Raleigh North Carolina United States
    23 Springfield Oregon United States
    24 Bala Cynwyd Pennsylvania United States
    25 Lancaster Pennsylvania United States
    26 Pittsburgh Pennsylvania United States
    27 Myrtle Beach South Carolina United States
    28 Nashville Tennessee United States
    29 Dallas Texas United States
    30 Salt Lake Utah United States
    31 Fairfax Virginia United States
    32 Norfolk Virginia United States
    33 Salem Virginia United States
    34 Burien Washington United States
    35 Ciudad Autonoma de Buenos Aires Argentina
    36 Santa Rosa Argentina
    37 Venado Tuerto Argentina
    38 Camperdown New South Wales Australia
    39 Coffs Harbour New South Wales Australia
    40 Darlinghurst New South Wales Australia
    41 Tweed Heads New South Wales Australia
    42 Richmond Victoria Australia
    43 Subiaco Western Australia Australia
    44 Bruxelles Belgium
    45 Gent Belgium
    46 Kortrijk Belgium
    47 Liege Belgium
    48 Botucatu, Sao Paulo Brazil
    49 Cachoeiro de Itapemirim - ES Brazil
    50 Curitiba, Parana Brazil
    51 Florianopolis Brazil
    52 Juiz de Fora, Minas Gerais Brazil
    53 Mogi das Cruzes, Sao Paulo Brazil
    54 Natal, Rio Grande do Norte Brazil
    55 Passo Fundo Brazil
    56 Porto Alegre, RS Brazil
    57 Rio de Janeiro Brazil
    58 Salvador/BA Brazil
    59 Sao Paulo Brazil
    60 Volta Redonda - RJ Brazil
    61 Pleven Bulgaria
    62 Plovdiv Bulgaria
    63 Sofia Bulgaria
    64 Varna Bulgaria
    65 Kelowna British Columbia Canada
    66 Victoria British Columbia Canada
    67 Brantford Ontario Canada
    68 North York Ontario Canada
    69 Oakville Ontario Canada
    70 Santiago Chile
    71 Temuco Chile
    72 Vina del Mar Chile
    73 Beijing China
    74 Chengdu China
    75 Shanghai China
    76 Shantou China
    77 Wuhan China
    78 Bogota Colombia
    79 Cali Colombia
    80 Novy Jicin Czech Republic
    81 Olomouc Czech Republic
    82 Praha 2 Czech Republic
    83 Praha 5 Czech Republic
    84 Usti nad Labem Czech Republic
    85 Tartu Estonia
    86 Angers France
    87 Cannes France
    88 Marseille France
    89 Montpellier France
    90 Paris France
    91 Pierre Benite France
    92 Rennes France
    93 Suresnes France
    94 Dresden Germany
    95 Hamburg Germany
    96 Koln Germany
    97 Mannheim Germany
    98 Marburg Germany
    99 Munchen Germany
    100 Munster Germany
    101 Nurtingen Germany
    102 Tubingen Germany
    103 Weiden Germany
    104 Athens Greece
    105 Patras Greece
    106 Thessaloniki Greece
    107 Pune India
    108 Beer-Sheva Israel
    109 Haifa Israel
    110 Jerusalem Israel
    111 Petach Tikva Israel
    112 Ramat-Gan Israel
    113 Tel-Aviv Israel
    114 Zerifin Israel
    115 Cremona Italy
    116 Lecco Italy
    117 Meldola Italy
    118 Milano Italy
    119 Padova Italy
    120 Ravenna Italy
    121 Roma Italy
    122 Torino Italy
    123 Gwangju Korea, Republic of
    124 Seoul Korea, Republic of
    125 Liepaja Latvia
    126 Riga Latvia
    127 Beirut Lebanon
    128 Bsalim Lebanon
    129 Kaunas Lithuania
    130 Vilnius Lithuania
    131 Chihuahua, Chih. Mexico
    132 Culiacan, Sinaloa Mexico
    133 Leon, GTO Mexico
    134 Puebla Mexico
    135 Zapopan, Jalisco Mexico
    136 Amsterdam Netherlands
    137 Groningen Netherlands
    138 Leiden Netherlands
    139 Nijmegen Netherlands
    140 Tilburg Netherlands
    141 Christchurch New Zealand
    142 Nelson New Zealand
    143 Palmerston North New Zealand
    144 Tauranga New Zealand
    145 Panama Panama
    146 Arequipa Peru
    147 Bialystok Poland
    148 Lodz Poland
    149 Myslowice Poland
    150 Poznan Poland
    151 Warszawa Poland
    152 Wroclaw Poland
    153 Baia Mare Romania
    154 Bucharest Romania
    155 Cluj-Napoca Romania
    156 Craiova Romania
    157 Ploiesti Romania
    158 Suceava Romania
    159 Timisoara Romania
    160 Ekaterinburg Russian Federation
    161 Moscow Russian Federation
    162 Novosibirsk Russian Federation
    163 Omsk Russian Federation
    164 St. Petersburg Russian Federation
    165 Vladimir Russian Federation
    166 Bratislava Slovakia
    167 Trencin Slovakia
    168 Sevilla Andalucia Spain
    169 Zaragoza Aragon Spain
    170 Oviedo Asturias Spain
    171 Santander Cantabria Spain
    172 Sabadell Cataluna Spain
    173 Alcorcon Madrid, Communidad de Spain
    174 Pamplona Navarra Spain
    175 Barcelona Spain
    176 San Sebastian de los Reyes Spain
    177 Valencia Spain
    178 Göteborg Sweden
    179 Karlstad Sweden
    180 Stockholm Sweden
    181 Kaohsiung Taiwan
    182 Taichung Taiwan
    183 Taipei Taiwan
    184 Taoyuan Taiwan
    185 Istanbul Turkey
    186 Chernivtsi Ukraine
    187 Dnipropetrovsk Ukraine
    188 Donetsk Ukraine
    189 Ivano-Frankivsk Ukraine
    190 Kharkiv Ukraine
    191 Kyiv Ukraine
    192 Lutsk Ukraine
    193 Lviv Ukraine
    194 Odesa Ukraine
    195 Uzhgorod Ukraine
    196 Zaporizhzhya Ukraine
    197 Birmingham United Kingdom
    198 Chichester United Kingdom
    199 Leeds United Kingdom
    200 London United Kingdom
    201 Northwood United Kingdom
    202 Nottingham United Kingdom
    203 Oxford United Kingdom
    204 Scunthorpe United Kingdom
    205 Sutton United Kingdom

    Sponsors and Collaborators

    • Active Biotech AB

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Active Biotech AB
    ClinicalTrials.gov Identifier:
    NCT01234311
    Other Study ID Numbers:
    • 10TASQ10
    First Posted:
    Nov 4, 2010
    Last Update Posted:
    Oct 21, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Oct 21, 2015