OGX-427 in Metastatic Castrate-Resistant Prostate Cancer With Prostate-Specific Antigen Progression While Receiving Abiraterone

Status: Recruiting
Phase: Phase 2
Diagnosis: Prostate Cancer
NCT ID: NCT01681433 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-439

 

This Phase II study has been designed to evaluate the anti-tumor effects of adding OGX-427 to continuing abiraterone acetate and prednisone treatment in men with metastatic castrate-resistant prostate cancer (MCRPC) who have prostate-specific antigen (PSA) progression

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Christopher Sweeney, Dana-Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Judith Prisby, 617-632-5068, jprisby@partners.org
Dana-Farber Cancer Institute: Meghara Walsh, 617-632-5264, mwalsh10@partners.org
Dana-Farber Cancer Institute: Amanda Fredericks, 617-632-5514, acfredericks@partners.org

Eligibility Criteria

Inclusion Criteria: Subjects must meet ALL of the following criteria to be eligible for inclusion into the study. - Histological or cytological diagnosis of adenocarcinoma of the prostate - Metastatic disease on chest, abdominal, or pelvic computed tomography (CT) scan and/or bone scan - Currently receiving abiraterone acetate and prednisone and meeting the following criteria: - Prior PSA response of ≥ 30% while receiving abiraterone - Currently tolerating abiraterone acetate (1000 mg oral daily) and prednisone (5-20 mg oral daily) - PSA progression, defined as an increase in PSA which is ≥ 25% and ≥ 2 ng/mL above the nadir and which is confirmed by a second value ≥ 2 weeks later. The last confirmation PSA value must be obtained within the 14 days prior to randomization. - No evidence of symptomatic or radiographic progression that would require alternative therapy (e.g., needing radiation therapy for pain or significant progression of visceral metastases) - All patients who have not had a surgical orchiectomy must continue treatment with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist to maintain a castrate level of testosterone. - Patient must fulfill "Prior Therapy" criteria as follows: - Chemotherapy: no more than 1 prior chemotherapy regimen for castrate-resistant prostate cancer (CRPC) is permitted; a minimum of at least 28 days must have passed since the last dose of chemotherapy. - Hormone therapy: hormonal androgen ablation therapy prior to abiraterone is required. - Experimental therapy: prior non-cytotoxic experimental therapy is permitted provided a minimum of at least 28 days has passed since completing therapy. Prior treatment with enzalutamide (MDV3100) is allowed. - Radiation: prior external beam radiation is permitted provided a minimum of at least 14 days have passed since completing radiotherapy (exception for radiotherapy: at least 7 days since completing a single fraction of ≤800 cGy to a restricted field or limited-field radiotherapy to non-marrow bearing area such as an extremity or orbit) at the time of randomization - Must be willing to use effective contraception throughout study treatment and for 3 months after completion of study treatment if able to father a child. - Must be willing not to change (add or subtract) bone protecting therapy (bisphosphonates and/or denosumab) during the study unless changed for toxicity. - Written informed consent must be obtained prior to any protocol-specific procedures being performed. Exclusion Criteria: Subjects meeting ANY of the following exclusion criteria will NOT be eligible for inclusion into the study: - Currently receiving abiraterone acetate in combination with any other anti-cancer agent (except prednisone) - Documented brain metastases, or carcinomatous meningitis, treated or untreated (Brain imaging for asymptomatic patients is not required.) - Cord compression requiring surgery or radiation therapy while on abiraterone treatment - Active second malignancy (including lymphoid malignancies such as chronic lymphocytic leukemia or low grade lymphoma) defined, in general, as requiring anticancer therapy or at high risk of recurrence during the study; not including adequately treated non melanomatous skin cancer or other solid tumors curatively treated with no evidence of disease in > 3 years - History of allergic reactions to therapeutic antisense oligonucleotides - Active autoimmune disease requiring treatment - Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment (i.e., either control or investigational arm), or prior exposure to OGX-427 - Uncontrolled medical conditions such as myocardial infarction, uncontrolled hypertension, stroke or treatment of a major active infection within 3 months of randomization, as well as any significant concurrent medical illness that in the opinion of the Investigator would preclude protocol therapy - Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device. Concomitant participation in observational studies is acceptable.
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