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)

NCT01083615 | Terminated Phase 3 DMC

• 1 other identifier: OGX-011-10
• Study Type: interventional
• Target: 14
• Locations: 5 countries
• Sites: 33

Brief Summary

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.

Conditions

Castrate-Resistant Prostate Cancer; Hormone Refractory Prostate Cancer

Keywords

CRPC patients with cancer related pain; CRPC; HRPC

Outcome Measures

Primary Outcomes (1)

• To ascertain whether the investigational arm has a greater proportion of patients with durable pain palliation as compared to the control arm.

  3 to 6 months

Secondary Outcomes (2)

• To ascertain whether patients randomized to the investigational arm have a longer time to pain progression as compared to patients randomized to the control arm.

  6 months.

• Safety

  6 months

Study Arms (2)

Custirsen

EXPERIMENTAL

Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of custirsen will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly custirsen infusions (640 mg total dose) on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID. Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.

Drug: custirsen sodium; Drug: docetaxel; Drug: cabazitaxel; Drug: prednisone

Placebo

PLACEBO COMPARATOR

Study treatment starts with a Loading Dose Period (1 week) during which 3 infusions of placebo (isotonic, 0.9% sodium chloride) will be administered. Following the Loading Dose Period, study treatment will consist of docetaxel (75 mg/m2 total dose) or cabazitaxel (25 mg/m2 total dose) on a 21-day cycle with weekly placebo infusions on Day 1, 8 and 15 of each 21-day cycle and oral prednisone BID. Participants will continue study treatment until pain progression, unacceptable toxicity, completion of 10 cycles or other specific criteria for withdrawal identified in the protocol.

Drug: isotonic, 0.9% sodium chloride; Drug: docetaxel; Drug: cabazitaxel; Drug: prednisone

Interventions

custirsen sodium DRUG

An antisense oligonucleotide that blocks production of clusterin

Also known as: OGX-011

Custirsen

isotonic, 0.9% sodium chloride DRUG

Placebo for custirsen sodium

Placebo

docetaxel DRUG

Custirsen; Placebo

cabazitaxel DRUG

Custirsen; Placebo

prednisone DRUG

Custirsen; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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.

Sponsors & Collaborators

• Achieve Life Sciences: lead
• Teva Pharmaceuticals USA: collaborator

Study Sites (33)

Unknown Facility

La Verne, California, 91705, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33308, United States

Location

Unknown Facility

Tampa, Florida, 33612, United States

Location

Unknown Facility

Honolulu, Hawaii, 96813, United States

Location

Unknown Facility

Urbana, Illinois, 61801, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

Baltimore, Maryland, 21201, United States

Location

Unknown Facility

Burlington, Massachusetts, 01805, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

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Kansas City, Missouri, 64132, United States

Location

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Omaha, Nebraska, 68130, United States

Location

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Las Vegas, Nevada, 89169, United States

Location

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Syracuse, New York, 13210, United States

Location

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Raleigh, North Carolina, 27607, United States

Location

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Canton, Ohio, 44718, United States

Location

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Oklahoma City, Oklahoma, 73120, United States

Location

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Portland, Oregon, 97239, United States

Location

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Columbia, South Carolina, 29209, United States

Location

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Memphis, Tennessee, 38120, United States

Location

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Tyler, Texas, 75701, United States

Location

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Winnipeg, Manitoba, R3E 0V9, Canada

Location

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Hamilton, Ontario, L8V 5C2, Canada

Location

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Lyon, France

Location

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Paris, France

Location

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Saint-Herblain, France

Location

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Villejuif, France

Location

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Barcelona, Spain

Location

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Madrid, Spain

Location

Unknown Facility

Pamplona, Spain

Location

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Sabadell, Spain

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

Cambridge, United Kingdom

Location

Unknown Facility

Sutton, United Kingdom

Location

MeSH Terms

Interventions

OGX-011; Sodium Chloride; Docetaxel; cabazitaxel; Prednisone

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Tomasz M Beer, M.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Sebastien J Hotte, M.D.

  Juravinski Cancer Centre, McMaster University

  PRINCIPAL INVESTIGATOR

• Karim Fizazi, M.D., Ph.D.

  Institut Gustave Roussy, University of Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2010
• First Posted: March 10, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 12, 2016

Record last verified: 2016-10

Locations

ES (5); GB (2); US (20); CA (2); FR (4)