PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TASQUINIMOD IN MEN WITH METASTATIC CASTRATE-RESISTANT PROSTATE CANCER

ACTIVE BIOTECH AB,0 个研究点目标入组 9 人开始时间: 2011年8月24日最近更新: 2023年9月4日

试验速览

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•1. AGE AT LEAST 18 YEARS AT TIME OF SIGNING THE ICF. 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 (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. (INCREASING LEVELS MUST BE CONFIRMED BY 3 CONSECUTIVE PSA MEASUREMENTS WITHIN 15 MONTHS [PREFERABLY WITH 14 DAYS, BUT WITH AT LEAST 7 DAYS BETWEEN EACH MEASUREMENT]).
•PROGRESSION OF SOFT TISSUE METASTASIS DOCUMENTED WITHIN 6 WEEKS OF ENROLLMENT BY COMPUTED TOMOGRAPHY (CT) SCAN OR MAGNETIC RESONANCE IMAGING MRI) SCAN.
•PROGRESSION OF BONE DISEASE (AT LEAST 1 NEW BONE LESION AS MEASURED BY BONE SCAN WITHIN THE PAST 12 WEEKS)
•6. KARNOFSKY SCORE ≥ 70%.

•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 OR MDV3100 WITHIN 4 WEEKS PRIOR TO THE START OF STUDY TREATMENT. IF RADIATION THERAPY IS APPLIED AFTER THE 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 ®).
•4. CONCURRENT USE OF OTHER ANTICANCER AGENTS OR TREATMENTS, WITH THE FOLLOWING EXCEPTIONS:
•ONGOING TREATMENT WITH LHRH AGONISTS OR ANTAGONISTS, DENOSUMAB (PROLIA) O BISPHOSPHONATES (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 TTRATMENT MODALITIES INVOLVING MAJOR SURGERY WITHIN 4 WEEKS PRIOR TO THE START OF STUDY TREATMENT.
•6. PROSTATE CANCER PAIN THAT REQUIRES ONGOING TREATMENT WITH NARCOTICS ANALGESICS OR WARRANTS THE INITIATION OF RADIO- OR CHEMOTHERAPY.

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