Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01234311




Registration number
NCT01234311
Ethics application status
Date submitted
1/11/2010
Date registered
4/11/2010
Date last updated
21/10/2015

Titles & IDs
Public title
A Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
Scientific title
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men With Metastatic Castrate Resistant Prostate Cancer
Secondary ID [1] 0 0
10TASQ10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - tasquinimod

Placebo comparator: placebo - Matching placebo

Experimental: tasquinimod - Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)


Treatment: Drugs: tasquinimod
Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study of Tasquinimod in Men with Metastatic Castrate Resistant Prostate Cancer
Timepoint [1] 0 0
5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2015
Sample size
Target
Accrual to date
Final
1245
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Coffs Harbour
Recruitment hospital [3] 0 0
- Darlinghurst
Recruitment hospital [4] 0 0
- Tweed Heads
Recruitment hospital [5] 0 0
- Richmond
Recruitment hospital [6] 0 0
- Subiaco
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Darlinghurst
Recruitment postcode(s) [4] 0 0
- Tweed Heads
Recruitment postcode(s) [5] 0 0
- Richmond
Recruitment postcode(s) [6] 0 0
- Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nevada
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Tennessee
Country [19] 0 0
United States of America
State/province [19] 0 0
Texas
Country [20] 0 0
United States of America
State/province [20] 0 0
Utah
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
Argentina
State/province [23] 0 0
Ciudad Autonoma de Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Santa Rosa
Country [25] 0 0
Argentina
State/province [25] 0 0
Venado Tuerto
Country [26] 0 0
Belgium
State/province [26] 0 0
Bruxelles
Country [27] 0 0
Belgium
State/province [27] 0 0
Gent
Country [28] 0 0
Belgium
State/province [28] 0 0
Kortrijk
Country [29] 0 0
Belgium
State/province [29] 0 0
Liege
Country [30] 0 0
Brazil
State/province [30] 0 0
Botucatu, Sao Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
Cachoeiro de Itapemirim - ES
Country [32] 0 0
Brazil
State/province [32] 0 0
Curitiba, Parana
Country [33] 0 0
Brazil
State/province [33] 0 0
Florianopolis
Country [34] 0 0
Brazil
State/province [34] 0 0
Juiz de Fora, Minas Gerais
Country [35] 0 0
Brazil
State/province [35] 0 0
Mogi das Cruzes, Sao Paulo
Country [36] 0 0
Brazil
State/province [36] 0 0
Natal, Rio Grande do Norte
Country [37] 0 0
Brazil
State/province [37] 0 0
Passo Fundo
Country [38] 0 0
Brazil
State/province [38] 0 0
Porto Alegre, RS
Country [39] 0 0
Brazil
State/province [39] 0 0
Rio de Janeiro
Country [40] 0 0
Brazil
State/province [40] 0 0
Salvador/BA
Country [41] 0 0
Brazil
State/province [41] 0 0
Sao Paulo
Country [42] 0 0
Brazil
State/province [42] 0 0
Volta Redonda - RJ
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Pleven
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Plovdiv
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Sofia
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Varna
Country [47] 0 0
Canada
State/province [47] 0 0
British Columbia
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Chile
State/province [49] 0 0
Santiago
Country [50] 0 0
Chile
State/province [50] 0 0
Temuco
Country [51] 0 0
Chile
State/province [51] 0 0
Vina del Mar
Country [52] 0 0
China
State/province [52] 0 0
Beijing
Country [53] 0 0
China
State/province [53] 0 0
Chengdu
Country [54] 0 0
China
State/province [54] 0 0
Shanghai
Country [55] 0 0
China
State/province [55] 0 0
Shantou
Country [56] 0 0
China
State/province [56] 0 0
Wuhan
Country [57] 0 0
Colombia
State/province [57] 0 0
Bogota
Country [58] 0 0
Colombia
State/province [58] 0 0
Cali
Country [59] 0 0
Czech Republic
State/province [59] 0 0
Novy Jicin
Country [60] 0 0
Czech Republic
State/province [60] 0 0
Olomouc
Country [61] 0 0
Czech Republic
State/province [61] 0 0
Praha 2
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Praha 5
Country [63] 0 0
Czech Republic
State/province [63] 0 0
Usti nad Labem
Country [64] 0 0
Estonia
State/province [64] 0 0
Tartu
Country [65] 0 0
France
State/province [65] 0 0
Angers
Country [66] 0 0
France
State/province [66] 0 0
Cannes
Country [67] 0 0
France
State/province [67] 0 0
Marseille
Country [68] 0 0
France
State/province [68] 0 0
Montpellier
Country [69] 0 0
France
State/province [69] 0 0
Paris
Country [70] 0 0
France
State/province [70] 0 0
Pierre Benite
Country [71] 0 0
France
State/province [71] 0 0
Rennes
Country [72] 0 0
France
State/province [72] 0 0
Suresnes
Country [73] 0 0
Germany
State/province [73] 0 0
Dresden
Country [74] 0 0
Germany
State/province [74] 0 0
Hamburg
Country [75] 0 0
Germany
State/province [75] 0 0
Koln
Country [76] 0 0
Germany
State/province [76] 0 0
Mannheim
Country [77] 0 0
Germany
State/province [77] 0 0
Marburg
Country [78] 0 0
Germany
State/province [78] 0 0
Munchen
Country [79] 0 0
Germany
State/province [79] 0 0
Munster
Country [80] 0 0
Germany
State/province [80] 0 0
Nurtingen
Country [81] 0 0
Germany
State/province [81] 0 0
Tubingen
Country [82] 0 0
Germany
State/province [82] 0 0
Weiden
Country [83] 0 0
Greece
State/province [83] 0 0
Athens
Country [84] 0 0
Greece
State/province [84] 0 0
Patras
Country [85] 0 0
Greece
State/province [85] 0 0
Thessaloniki
Country [86] 0 0
India
State/province [86] 0 0
Pune
Country [87] 0 0
Israel
State/province [87] 0 0
Beer-Sheva
Country [88] 0 0
Israel
State/province [88] 0 0
Haifa
Country [89] 0 0
Israel
State/province [89] 0 0
Jerusalem
Country [90] 0 0
Israel
State/province [90] 0 0
Petach Tikva
Country [91] 0 0
Israel
State/province [91] 0 0
Ramat-Gan
Country [92] 0 0
Israel
State/province [92] 0 0
Tel-Aviv
Country [93] 0 0
Israel
State/province [93] 0 0
Zerifin
Country [94] 0 0
Italy
State/province [94] 0 0
Cremona
Country [95] 0 0
Italy
State/province [95] 0 0
Lecco
Country [96] 0 0
Italy
State/province [96] 0 0
Meldola
Country [97] 0 0
Italy
State/province [97] 0 0
Milano
Country [98] 0 0
Italy
State/province [98] 0 0
Padova
Country [99] 0 0
Italy
State/province [99] 0 0
Ravenna
Country [100] 0 0
Italy
State/province [100] 0 0
Roma
Country [101] 0 0
Italy
State/province [101] 0 0
Torino
Country [102] 0 0
Korea, Republic of
State/province [102] 0 0
Gwangju
Country [103] 0 0
Korea, Republic of
State/province [103] 0 0
Seoul
Country [104] 0 0
Latvia
State/province [104] 0 0
Liepaja
Country [105] 0 0
Latvia
State/province [105] 0 0
Riga
Country [106] 0 0
Lebanon
State/province [106] 0 0
Beirut
Country [107] 0 0
Lebanon
State/province [107] 0 0
Bsalim
Country [108] 0 0
Lithuania
State/province [108] 0 0
Kaunas
Country [109] 0 0
Lithuania
State/province [109] 0 0
Vilnius
Country [110] 0 0
Mexico
State/province [110] 0 0
Chihuahua, Chih.
Country [111] 0 0
Mexico
State/province [111] 0 0
Culiacan, Sinaloa
Country [112] 0 0
Mexico
State/province [112] 0 0
Leon, GTO
Country [113] 0 0
Mexico
State/province [113] 0 0
Puebla
Country [114] 0 0
Mexico
State/province [114] 0 0
Zapopan, Jalisco
Country [115] 0 0
Netherlands
State/province [115] 0 0
Amsterdam
Country [116] 0 0
Netherlands
State/province [116] 0 0
Groningen
Country [117] 0 0
Netherlands
State/province [117] 0 0
Leiden
Country [118] 0 0
Netherlands
State/province [118] 0 0
Nijmegen
Country [119] 0 0
Netherlands
State/province [119] 0 0
Tilburg
Country [120] 0 0
New Zealand
State/province [120] 0 0
Christchurch
Country [121] 0 0
New Zealand
State/province [121] 0 0
Nelson
Country [122] 0 0
New Zealand
State/province [122] 0 0
Palmerston North
Country [123] 0 0
New Zealand
State/province [123] 0 0
Tauranga
Country [124] 0 0
Panama
State/province [124] 0 0
Panama
Country [125] 0 0
Peru
State/province [125] 0 0
Arequipa
Country [126] 0 0
Poland
State/province [126] 0 0
Bialystok
Country [127] 0 0
Poland
State/province [127] 0 0
Lodz
Country [128] 0 0
Poland
State/province [128] 0 0
Myslowice
Country [129] 0 0
Poland
State/province [129] 0 0
Poznan
Country [130] 0 0
Poland
State/province [130] 0 0
Warszawa
Country [131] 0 0
Poland
State/province [131] 0 0
Wroclaw
Country [132] 0 0
Romania
State/province [132] 0 0
Baia Mare
Country [133] 0 0
Romania
State/province [133] 0 0
Bucharest
Country [134] 0 0
Romania
State/province [134] 0 0
Cluj-Napoca
Country [135] 0 0
Romania
State/province [135] 0 0
Craiova
Country [136] 0 0
Romania
State/province [136] 0 0
Ploiesti
Country [137] 0 0
Romania
State/province [137] 0 0
Suceava
Country [138] 0 0
Romania
State/province [138] 0 0
Timisoara
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Ekaterinburg
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Moscow
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Novosibirsk
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Omsk
Country [143] 0 0
Russian Federation
State/province [143] 0 0
St. Petersburg
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Vladimir
Country [145] 0 0
Slovakia
State/province [145] 0 0
Bratislava
Country [146] 0 0
Slovakia
State/province [146] 0 0
Trencin
Country [147] 0 0
Spain
State/province [147] 0 0
Andalucia
Country [148] 0 0
Spain
State/province [148] 0 0
Aragon
Country [149] 0 0
Spain
State/province [149] 0 0
Asturias
Country [150] 0 0
Spain
State/province [150] 0 0
Cantabria
Country [151] 0 0
Spain
State/province [151] 0 0
Cataluna
Country [152] 0 0
Spain
State/province [152] 0 0
Madrid, Communidad de
Country [153] 0 0
Spain
State/province [153] 0 0
Navarra
Country [154] 0 0
Spain
State/province [154] 0 0
Barcelona
Country [155] 0 0
Spain
State/province [155] 0 0
San Sebastian de los Reyes
Country [156] 0 0
Spain
State/province [156] 0 0
Valencia
Country [157] 0 0
Sweden
State/province [157] 0 0
Göteborg
Country [158] 0 0
Sweden
State/province [158] 0 0
Karlstad
Country [159] 0 0
Sweden
State/province [159] 0 0
Stockholm
Country [160] 0 0
Taiwan
State/province [160] 0 0
Kaohsiung
Country [161] 0 0
Taiwan
State/province [161] 0 0
Taichung
Country [162] 0 0
Taiwan
State/province [162] 0 0
Taipei
Country [163] 0 0
Taiwan
State/province [163] 0 0
Taoyuan
Country [164] 0 0
Turkey
State/province [164] 0 0
Istanbul
Country [165] 0 0
Ukraine
State/province [165] 0 0
Chernivtsi
Country [166] 0 0
Ukraine
State/province [166] 0 0
Dnipropetrovsk
Country [167] 0 0
Ukraine
State/province [167] 0 0
Donetsk
Country [168] 0 0
Ukraine
State/province [168] 0 0
Ivano-Frankivsk
Country [169] 0 0
Ukraine
State/province [169] 0 0
Kharkiv
Country [170] 0 0
Ukraine
State/province [170] 0 0
Kyiv
Country [171] 0 0
Ukraine
State/province [171] 0 0
Lutsk
Country [172] 0 0
Ukraine
State/province [172] 0 0
Lviv
Country [173] 0 0
Ukraine
State/province [173] 0 0
Odesa
Country [174] 0 0
Ukraine
State/province [174] 0 0
Uzhgorod
Country [175] 0 0
Ukraine
State/province [175] 0 0
Zaporizhzhya
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Birmingham
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Chichester
Country [178] 0 0
United Kingdom
State/province [178] 0 0
Leeds
Country [179] 0 0
United Kingdom
State/province [179] 0 0
London
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Northwood
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Nottingham
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Oxford
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Scunthorpe
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Active Biotech AB
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael A Carducci, MD
Address 0 0
Johns Hopkins Kimmel Cancer Center, Baltimore, MD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01234311