Health Condition 1: null- Metastatic Castrate Resistant Prostate Cancer
Conditions
Interventions
Intervention1: Drug: tasquinimod: 0.25 mg/day of tasquinimod for at least 2 weeks. Once tolerability of the 0.25 mg/day dose is established, patients will receive a dose increase to 0.5 mg/day for at
Sponsors
Active Biotech
PPD Pharmaceutical Development India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at least 18 years and less than or equal 80 years at the time of signing the informed consent form. 2. Asymptomatic or mildly symptomatic (as per decision of investigator) histologically confirmed adenocarcinoma of the prostate. 3. Histologically confirmed diagnosis of adenocarcinoma of the prostate. 4. Evidence of bone metastatic disease on radiographic examination, whether from bone scan (bone lesions) or other imaging modality. 5. Castrate levels of serum testosterone (less than or equal 50 ng/dL or 1.7 nmol/L). 6. Evidence of progressive disease after castration levels of testosterone have been achieved. 7. Karnofsky score more than or equal 70%. 8. Meet screening laboratory values as specified in thr protocol. 9. 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. 10. No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin). 11. Able to swallow and retain oral medication. 12. Able to adhere to the study visit schedule and other protocol requirements. 13. 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. 14. Able (or patients 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
Exclusion criteria: 1. Prior cytotoxic chemotherapy for the treatment of prostate cancer 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 cancer pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio- or chemotherapy. 7. Ongoing treatment with warfarin. Treatment with other anticoagulants is allowed but should be discussed with medical monitor before inclusion. 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 tube
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| NATimepoint: NA | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Estonia, France, Germany, Greece, India, Ireland, Italy, Latvia, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Republic of Korea, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactArun Sundriyal
PPD Pharmaceutical Development India Pvt. Ltd.
Outcome results
None listed