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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

2. Histologically confirmed diagnosis of adenocarcinoma of the prostate.
3. Evidence of bone metastatic disease on radiographic examination, whether from bone scan (bone lesions) or other imaging modality.
4. Castrate levels of serum testosterone (<=50 ng/dL or 1.7 nmol/L).
5. Evidence of progressive disease after castration levels of testosterone have been achieved, defined by any of the following criteria:
• Increasing serum PSA levels, the most recent value >=2 ng/mL.
• Progression of soft tissue metastasis documented within 6 weeks of enrollment (computed tomography [CT] scan or magnetic resonance imaging [MRI])
• Progression of bone disease (at least 1 new bone lesion as measured by bone scan within the past 12 weeks)
6. Karnofsky score >=70%.
7. Laboratory values as follows:
• Hemoglobin >=100 g/L (>10 g/dL)
• Absolute neutrophil count >=1500/µL
• Platelets >=100 000/µL
• Serum creatinine <=1.5 times the upper limit of normal (ULN)
• Total bilirubin <=1.5 times ULN
• Aspartate aminotransferase and alanine aminotransferase <=3 times ULN
9. No evidence (within 5 years) of prior malignancies (except successfully treated basal cell or squamous cell carcinoma of the skin).;Inclusion criteria for the open-label extension treatment phase: In order to be enrolled in the OLE treatment phase, each patient must meet all of the OLE inclusion criteria. The open-label Day 1 visit should be at the planned patient visit following unblinding and within no more than 4 months after this amendment is approved and becomes effective at the study site.
1. Received tasquinimod or placebo treatment in the randomized doubleblind treatment phase of this study.
2. Willing and able to give informed consent for OLE treatment.
3. All of the safety related inclusion criteria for the main study, numbers 6 to 8 and 10 to 12.
4. No evidence (within 5 years) of prior malignancies (except
successfully treated basal cell or squamous cell carcinoma of the skin) or, in case of occurrence of a cancer during the study, the option to switch to the OLE treatment phase will be done on a case-by-case basis taking into account the benefit/risk for the patient.

Exclusion Criteria

1. Prior cytotoxic chemotherapy for the treatment of prostate cancer within 2 years.
2. Previous anticancer therapy using radiation, biologics or vaccines, including sipuleucel-T (Provenge), abiraterone, TAK-700 (Ortenel), or MDV3100 within 4 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®)
6. Prostate cancer pain that requires ongoing treatment with narcotic analgesics or warrants the initiation of radio -or chemotherapy..
15. Known brain or epidural metastases.
16. Known positive serology for HIV
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. ;Exclusion criteria for the open-label extension treatment phase: Patients meeting any of the following criteria will be excluded from being enrolled in the OLE treatment phase:
1. Having met any of the reasons for withdrawal from study treatment.
2. Having met any of the safety related exclusion criteria for the mainstudy, numbers 6 to 20.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is Progression-free survival defined as the time from the<br /><br>date of randomization to the date of radiological progression or death. </p><br>

Secondary Outcome Measures