Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer
- Conditions
- Prostate Cancer
- Interventions
- Registration Number
- NCT01188187
- Lead Sponsor
- Achieve Life Sciences
- Brief Summary
This Phase 3 study has been designed to confirm that adding custirsen to standard first-line docetaxel/prednisone treatment can slow tumor progression and enhance survival outcomes compared to standard first-line docetaxel/prednisone treatment alone. This will be a randomized, open-label, multicenter, international trial. Treatment will consist of docetaxel/prednisone/custirsen vs. docetaxel/prednisone. A total of at least 1000 patients will be randomized. Patients will be randomly assigned with equal probability to the two arms.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1022
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Custirsen, Docetaxel, Prednisone Docetaxel Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. Custirsen, Docetaxel, Prednisone Prednisone Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. Custirsen, Docetaxel, Prednisone Dexamethasone Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. Docetaxel, Prednisone Docetaxel Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. Docetaxel, Prednisone Dexamethasone Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. Docetaxel, Prednisone Prednisone Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression. Custirsen, Docetaxel, Prednisone Custirsen Three doses of 640 mg custirsen administered intravenously (IV) as a loading dose between Days -9 to -1. Custirsen, 640 mg, given IV weekly on Days 1, 8, and 15 of each 21-day cycle. Docetaxel (75 mg/M\^2 via intravenous injection) on Day 1 of every 21 days plus prednisone (5 mg tablets taken by mouth) twice each day and dexamethasone (8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration). Treatment continues for 10 cycles or until unacceptable toxicity or disease progression.
- Primary Outcome Measures
Name Time Method Kaplan-Meier Estimates for Time to Death (Overall Survival) Randomization (approximately Day -12) to longest survival follow-up (Day 971). Time from the date of randomization to death from any cause. After stopping treatment, patients were followed every 4 weeks until disease progression and then followed every 12 weeks until death.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Adverse Events Docetaxel/prednisone/custirsen arm: Days -9 up to Day 743. Docetaxel/prednisone arm: Day 1 up to Day 400. An adverse event (AE) is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the administration, at any dose, of a medicinal or therapeutic product whether or not considered related to that product. Severity was rated by the investigator on a scale of 1 (mild) to 5 (death). A severity of 3 = Severe or medically significant but not immediately life-threatening. A severity of 4 = Life-threatening. Serious AEs include death (death due to progressive disease were not reported as an SAE), a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.
Percentage of Participants Who Were Alive Without Event At Day 140 Day 125-155 Patients who were alive without event (AWE) are patients who had their Milestone Day 140 Disease Status performed per protocol (Day 125 - Day 155 window), were not determined to have disease progression by the investigator on that window and confirmed as not having progressive disease (NONPD) by the Central Imagine Lab independent review.
Trial Locations
- Locations (140)
Teva Investigational Site 852
🇳🇱Rotterdam, Netherlands
Teva Investigational Site 093
🇺🇸Marina del Rey, California, United States
Teva Investigational Site 100
🇺🇸Birmingham, Alabama, United States
Teva Investigational Site 098
🇺🇸Ann Arbor, Michigan, United States
Teva Investigational Site 032
🇺🇸Rochester, Minnesota, United States
Teva Investigational Site 851
🇳🇱Amsterdam, Netherlands
Teva Investigational Site 756
🇮🇹Napoli, Italy
Teva Investigational Site 400
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 404
🇰🇷Cheongju,Chungbuk, Korea, Republic of
Teva Investigational Site 401
🇰🇷Goyang-si Gyeonggi-do, Korea, Republic of
Teva Investigational Site 696
🇭🇺Gyor, Hungary
Teva Investigational Site 750
🇮🇹Roma, Italy
Teva Investigational Site 699
🇭🇺Nyiregyhaza, Hungary
Teva Investigational Site 695
🇭🇺Veszprem, Hungary
Teva Investigational Site 694
🇭🇺Budapest, Hungary
Teva Investigational Site 112
🇺🇸Detroit, Michigan, United States
Teva Investigational Site 107
🇺🇸Cincinnati, Ohio, United States
Teva Investigational Site 806
🇪🇸Madrid, Spain
Teva Investigational Site 023
🇨🇦Edmonton, Alberta, Canada
Teva Investigational Site 697
🇭🇺Debrecen, Hungary
Teva Investigational Site 406
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 810
🇪🇸Murcia, Spain
Teva Investigational Site 813
🇪🇸Madrid, Spain
Teva Investigational Site 811
🇪🇸Palma de Mallorca, Spain
Teva Investigational Site 610
🇩🇪Tuebingen, Germany
Teva Investigational Site 502
🇮🇱Ramat Gan, Israel
Teva Investigational Site 566
🇫🇷Saint-Brieuc Cedex, France
Teva Investigational Site 608
🇩🇪Marburg, Germany
Teva Investigational Site 691
🇭🇺Budapest, Hungary
Teva Investigational Site 698
🇭🇺Miskolc, Hungary
Teva Investigational Site 506
🇮🇱Jerusalem, IL, Israel
Teva Investigational Site 602
🇩🇪Nuertingen, Germany
Teva Investigational Site 809
🇪🇸Barcelona, Spain
Teva Investigational Site 758
🇮🇹Catanzaro, Italy
Teva Investigational Site 760
🇮🇹Cesena (FC), Italy
Teva Investigational Site 501
🇮🇱Zrifin, Israel
Teva Investigational Site 402
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 507
🇮🇱Haifa, Israel
Teva Investigational Site 503
🇮🇱Tel Aviv, Israel
Teva Investigational Site 816
🇪🇸Dos Hermanas, Spain
Teva Investigational Site 403
🇰🇷Seoul, Korea, Republic of
Teva Investigational Site 405
🇰🇷Yangsan-si, Korea, Republic of
Teva Investigational Site 808
🇪🇸Barcelona, Spain
Teva Investigational Site 853
🇳🇱Sittard-Geleen, Netherlands
Teva Investigational Site 807
🇪🇸Guadalajara, Spain
Teva Investigational Site 805
🇪🇸Pamplona, Spain
Teva Investigational Site 803
🇪🇸Barcelona, Spain
Teva Investigational Site 814
🇪🇸El Palmar, Spain
Teva Investigational Site 804
🇪🇸Sabadell - Barcelona, Spain
Teva Investigational Site 802
🇪🇸Valencia, Spain
Teva Investigational Site 815
🇪🇸Manresa, Spain
Teva Investigational Site 753
🇮🇹Arezzo, Italy
Teva Investigational Site 759
🇮🇹Meldola (FC), Italy
Teva Investigational Site 752
🇮🇹Genova, Italy
Teva Investigational Site 755
🇮🇹Lugo (Ravenna), Italy
Teva Investigational Site 762
🇮🇹Roma, Italy
Teva Investigational Site 763
🇮🇹Milano, Italy
Teva Investigational Site 754
🇮🇹Napoli, Italy
Teva Investigational Site 761
🇮🇹Rimini, Italy
Teva Investigational Site 764
🇮🇹Rozzano (MI), Italy
Teva Investigational Site 765
🇮🇹Verona, Italy
Teva Investigational Site 704
🇬🇧Brighton, United Kingdom
Teva Investigational Site 709
🇬🇧Coventry, United Kingdom
Teva Investigational Site 705
🇬🇧Guildford, Surrey, United Kingdom
Teva Investigational Site 700
🇬🇧Surrey, United Kingdom
Teva Investigational Site 603
🇩🇪Stuttgart, Germany
Teva Investigational Site 605
🇩🇪Wuppertal, Germany
Teva Investigational Site 505
🇮🇱Petach Tikva, Israel
Teva Investigational Site 692
🇭🇺Debrecen, Hungary
Teva Investigational Site 693
🇭🇺Szeged, Hungary
Teva Investigational Site 860
🇧🇪Brussels, Belgium
Teva Investigational Site 094
🇺🇸Port St. Lucie, Florida, United States
Teva Investigational Site 103
🇺🇸Baton Rough, Louisiana, United States
Teva Investigational Site 102
🇺🇸Myrtle Beach, South Carolina, United States
Teva Investigational Site 101
🇺🇸Nashville, Tennessee, United States
Teva Investigational Site 862
🇧🇪Bonheiden, Belgium
Teva Investigational Site 047
🇺🇸Newport, Virginia, United States
Teva Investigational Site 063
🇺🇸Tyler, Texas, United States
Teva Investigational Site 864
🇧🇪Edegem, Belgium
Teva Investigational Site 863
🇧🇪Gent, Belgium
Teva Investigational Site 001
🇨🇦Vancouver, British Columbia, Canada
Teva Investigational Site 002
🇨🇦Calgary, Alberta, Canada
Teva Investigational Site 025
🇨🇦Hamilton, Ontario, Canada
Teva Investigational Site 028
🇨🇦Halifax, Nova Scotia, Canada
Teva Investigational Site 118
🇨🇦Abbotsford, British Columbia, Canada
Teva Investigational Site 091
🇨🇦Oshawa, Ontario, Canada
Teva Investigational Site 026
🇨🇦Montreal, Quebec, Canada
Teva Investigational Site 027
🇨🇦Montreal, Quebec, Canada
Teva Investigational Site 551
🇫🇷Angers Cedex 9, France
Teva Investigational Site 557
🇫🇷Marseille, France
Teva Investigational Site 555
🇫🇷La Roche-sur-Yon Cedex, France
Teva Investigational Site 560
🇫🇷Paris Cedex 05, France
Teva Investigational Site 558
🇫🇷Nice Cedex 2, France
Teva Investigational Site 561
🇫🇷Saint Herblain Cedex, France
Teva Investigational Site 562
🇫🇷Saint-Priest-en-Jarez Cedex, France
Teva Investigational Site 550
🇫🇷Villejuif, France
Teva Investigational Site 564
🇫🇷Vandoeuvre-les-Nancy Cedex, France
Teva Investigational Site 609
🇩🇪Berlin, Germany
Teva Investigational Site 613
🇩🇪Berlin, Germany
Teva Investigational Site 607
🇩🇪Aachen, Germany
Teva Investigational Site 604
🇩🇪Darmstadt, Germany
Teva Investigational Site 612
🇩🇪Dresden, Germany
Teva Investigational Site 600
🇩🇪Hannover, Germany
Teva Investigational Site 611
🇩🇪Homburg/Saar, Germany
Teva Investigational Site 606
🇩🇪Heidelberg, Germany
Teva Investigational Site 617
🇩🇪Kempen, Germany
Teva Investigational Site 614
🇩🇪Muenchen, Germany
Teva Investigational Site 601
🇩🇪Muenster, Germany
Teva Investigational Site 800
🇪🇸Madrid, Spain
Teva Investigational Site 710
🇬🇧Wirral, United Kingdom
Teva Investigational Site 086
🇺🇸Los Angeles, California, United States
Teva Investigational Site 097
🇺🇸San Diego, California, United States
Teva Investigational Site 204
🇺🇸Las Vegas, Nevada, United States
Teva Investigational Site 090
🇺🇸Fort Collins, Colorado, United States
Teva Investigational Site 029
🇺🇸Seattle, Washington, United States
Teva Investigational Site 106
🇺🇸Fort Myers, Florida, United States
Teva Investigational Site 096
🇺🇸Atlanta, Georgia, United States
Teva Investigational Site 108
🇨🇦Kingston, Ontario, Canada
Teva Investigational Site 059
🇺🇸Tyler, Texas, United States
Teva Investigational Site 084
🇺🇸Memphis, Tennessee, United States
Teva Investigational Site 266
🇺🇸Greensboro, South Carolina, United States
Teva Investigational Site 116
🇺🇸San Antonio, Texas, United States
Teva Investigational Site 024
🇨🇦Winnipeg, Manitoba, Canada
Teva Investigational Site 104
🇺🇸Norfolk, Virginia, United States
Teva Investigational Site 559
🇫🇷Paris Cedex 15, France
Teva Investigational Site 003
🇨🇦Ottawa, Ontario, Canada
Teva Investigational Site 004
🇨🇦Toronto, Ontario, Canada
Teva Investigational Site 552
🇫🇷Avignon, France
Teva Investigational Site 087
🇨🇦Toronto, Ontario, Canada
Teva Investigational Site 563
🇫🇷Toulouse, France
Teva Investigational Site 553
🇫🇷Grenoble, France
Teva Investigational Site 618
🇩🇪Greifswald, Germany
Teva Investigational Site 616
🇩🇪Meiningen, Germany
Teva Investigational Site 703
🇬🇧Manchester, United Kingdom
Teva Investigational Site 701
🇬🇧Cambridge, United Kingdom
Teva Investigational Site 615
🇩🇪Heinsberg, Germany
Teva Investigational Site 801
🇪🇸Madrid, Spain
Teva Investigational Site 085
🇨🇦Victoria, British Columbia, Canada
Teva Investigational Site 007
🇨🇦Surrey, British Columbia, Canada
Teva Investigational Site 263
🇺🇸Los Angeles, California, United States