A Study Evaluating the Pain Palliation Benefit of Adding Custirsen to Docetaxel Retreatment or Cabazitaxel as Second Line Therapy in Men With Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Castrate-Resistant Prostate Cancer, Hormone Refractory Prostate Cancer

In brief

The purpose of this study is to determine if the addition of study drug (custirsen) can provide durable pain palliation for castrate resistant prostate cancer patients receiving docetaxel retreatment or cabazitaxel as a second line therapy.

Key facts

Study ID

NCT01083615

Run by

Achieve Life Sciences

People needed

14

Starts

2010-03-01

Expected to finish

2013-03-01

Last updated by the study team

2016-10-12

Who can join

Age: 18 and older, up to 99. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years on the date of consent.
• Histological or cytological diagnosis of adenocarcinoma of the prostate.
• Metastatic disease at screening on a chest, abdomen or pelvic CT or bone scan.
• Concurrent pain and analgesic use that is viewed by the Investigator to be related to prostate cancer.
• Received at least 4 cycles of prior docetaxel-based first-line chemotherapy for metastatic disease based on a q3 week schedule of docetaxel. Patients treated on a weekly or alternate schedule for first-line docetaxel must have received an accumulated dose of docetaxel of at least 300 mg/M2.
• Current progressive disease during or after completing first-line docetaxel treatment.
• Baseline laboratory values at screening visit within protocol defined limits.
• Must be willing to continue primary androgen suppression with luteinizing hormone releasing hormone (LHRH) analogues throughout the study, if not treated with bilateral orchiectomy.
• Adequate bone marrow function.
• Karnofsky score ≥ 70% at screening visit.
• At least 21 days have passed since completing radiotherapy at the time of randomization.
• At least 21 days have passed since completing any cytotoxic agent or investigational agent given in combination with the docetaxel-based first-line therapy, including ASOs (except custirsen which is an exclusion criterion), at the time of randomization.
• Has recovered from all therapy related toxicity to ≤ grade 2 (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy).
• Patient can tolerate a starting dose of docetaxel of 75 mg/M2 or cabazitaxel at 25 mg/M2.
• Patient must have remained on the same bisphosphonate or denosumab usage for a minimum of 12 weeks prior to randomization.
• Written informed consent must be obtained prior to any protocol-specific procedures being performed.

You may not qualify if…

• More than two interruptions in first-line docetaxel therapy. An interruption will be defined as more than 6 weeks between doses.
• Life expectancy less than 12 weeks.
• Previously participated in any clinical trial evaluating custirsen.
• Received any other cytotoxic chemotherapy as a second-line treatment after first-line docetaxel-based therapy.
• Not on any opioid analgesic regimen for their prostate cancer-related pain.
• Receiving more than one drug within each of the separate categories of long-acting opioid, short-acting opioid, and non-opioid.
• Receiving any analgesic specified in the protocol as unacceptable for this study.
• Planned concomitant participation in another clinical trial of an experimental agent, vaccine or device. Concomitant participation in observational studies is acceptable.
• Inability to communicate and read in English, Spanish or French.

Where it is running

• Study site — La Verne, California, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Urbana, Illinois, United States
• Study site — Metairie, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Burlington, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Syracuse, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Canton, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Portland, Oregon, United States
• Study site — Columbia, South Carolina, United States
• Study site — Memphis, Tennessee, United States
• Study site — Tyler, Texas, United States
• Study site — Winnipeg, Manitoba, Canada
• Study site — Hamilton, Ontario, Canada
• Study site — Lyon, France
• Study site — Paris, France
• Study site — Saint-Herblain, France

Full record on ClinicalTrials.gov

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