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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Drugs - Placebo

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)

Treatment: Drugs: Placebo
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
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- Camperdown
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- Coffs Harbour
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- Darlinghurst
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- Tweed Heads
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- Richmond
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- Subiaco
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- Camperdown
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- Coffs Harbour
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- Darlinghurst
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- Tweed Heads
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- Richmond
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- Subiaco
Recruitment outside Australia
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Uzhgorod
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Zaporizhzhya
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Birmingham
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Chichester
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London
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Northwood
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Oxford
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Sutton

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

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01234311
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01234311