Comparison of Cabazitaxel/Prednisone Alone or in Combination With Custirsen for 2nd Line Chemotherapy in Prostate Cancer

Completed · Phase 3

Conditions studied: Prostate Cancer

In brief

This Phase 3 study has been designed to confirm that adding custirsen to cabazitaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard cabazitaxel/prednisone treatment in men with metastatic castrate resistant prostate cancer (CRPC). This will be a randomized, open-label, multicenter, international trial. Treatment will consist of cabazitaxel/prednisone/custirsen vs. cabazitaxel/prednisone. A total of approximately 630 patients will be randomized with equal probability to the two arms.

Key facts

Study ID

NCT01578655

Run by

Achieve Life Sciences

People needed

630

Starts

2012-08-01

Expected to finish

2016-07-01

Last updated by the study team

2016-10-12

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Histological or cytological diagnosis of adenocarcinoma of the prostate
• Metastatic disease on chest, abdominal, or pelvic CT scan and/or bone scan
• Previous first-line treatment for CRPC with a docetaxel-containing regimen
• Current progressive disease
• Increasing serum PSA level (for patients who progress based only on increasing serum PSA level, a minimum starting value of 5.0 ng/mL is required)
• Baseline laboratory values as defined
• Willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (unless treated with bilateral orchiectomy)
• Karnofsky score ≥70%
• At least 21 days have passed since completing radiotherapy
• At least 21 days have passed since receiving any investigational agent at the time of randomization
• At least 21 days have passed since major surgery
• Recovered from any docetaxel therapy-related neuropathy to ≤grade 1 at the time of randomization
• Recovered from all therapy related toxicity to ≤grade 2 (except alopecia, anemia, and any signs or symptoms of androgen deprivation therapy) at the time of randomization
• Able to tolerate a starting dose of 25 mg/m² cabazitaxel
• Willing to not add, delete, or change current bisphosphonate or denosumab usage
• Able to tolerate oral prednisone at 10 mg per day
• Competent to provide written informed consent

You may not qualify if…

• Received any other cytotoxic chemotherapy beyond the first-line docetaxel-containing regimen as treatment for prostate cancer
• Received prior radioisotope with strontium 89 or samarium 153
• Received any cycling, intermittent, or continuous hormonal treatment within 21 days prior to randomization with the exception of the continuous GnRH analogues (prior treatment with abiraterone or MDV3100 is allowed as long as 21 days have passed since last dose)
• Participated in a prior Phase 3 clinical study evaluating custirsen regardless of study arm assignment
• Requiring ongoing treatment during the study with medications known to be either strong CYP3A inhibitors or strong CYP3A inducers
• History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated
• Current symptomatic cord compression requiring surgery or radiation therapy
• Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined in general as requiring anticancer therapy or at high risk of recurrence during the study
• Uncontrolled medical condition or significant concurrent illness that in the opinion of the Investigator would preclude protocol therapy
• Known severe hypersensitivity to taxanes or polysorbate 80-containing drugs
• Planned concomitant participation in another clinical trial of an experimental agent, vaccine, or device

Where it is running

• University of California Davis Medical Center — Sacramento, California, United States
• Sharp Health Care — San Diego, California, United States
• California Pacific Medical Center Research Institute — San Francisco, California, United States
• Rocky Mountain Cancer Center — Boulder, Colorado, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Smilow Cancer Hospital at Yale New Haven Hospital — New Haven, Connecticut, United States
• The Center for Hematology-Oncology — Boca Raton, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Florida Cancer Specialists — Inverness, Florida, United States
• H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Georgia Cancer Specialists, P.C. — Marietta, Georgia, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• Boston University Medical Center — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Urology Cancer Center and GU Research Network — Omaha, Nebraska, United States
• Monter Cancer Center — Lake Success, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• Albert Einstein Medical Center — The Bronx, New York, United States
• Blumenthal Cancer Center — Charlotte, North Carolina, United States
• Cancer Centers of North Carolina — Raleigh, North Carolina, United States
• Oncology Hematology Care, Inc. — Blue Ash, Ohio, United States
• The Mark H. Zangmeister Center — Columbus, Ohio, United States
• Prostate Oncology Specialists — Marina del Rey, California, United States

Full record on ClinicalTrials.gov

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