Comparison of Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With OGX-011 in Men With Prostate Cancer (SYNERGY)

This study has been completed.
Sponsor:
Collaborator:
OncoGenex Technologies
Information provided by (Responsible Party):
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT01188187
First received: August 23, 2010
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Drug: Custirsen Sodium, Docetaxel, Prednisone
Drug: Docetaxel, Prednisone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Phase 3 Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination With Custirsen (OGX-011) in Men With Metastatic Castrate Resistant Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 31 months ] [ Designated as safety issue: No ]
    To ascertain whether the survival time distribution for patients randomized to the investigational arm is consistent with longer survival as compared to patients randomized to the control arm.


Secondary Outcome Measures:
  • Progression-free survival at Day 140 [ Time Frame: 23 months ] [ Designated as safety issue: No ]
    To compare the arms with respect to the proportion of patients having a milestone Day 140 status of alive without event (within the window of Day 125-155 post-randomization). An event is having disease progression or death on or before Day 140.

  • Safety profile [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
    To assess the safety profile of OGX-011 in combination with docetaxel and prednisone.

  • Progression-free survival at Day 225 [ Time Frame: 26 months ] [ Designated as safety issue: Yes ]
    To compare the arms with respect to the proportion of patients surviving to Day 225

  • PSA measurements [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    To compare the arms with respect to PSA trend measures where the trend measure is estimated separately for each patient.


Enrollment: 1023
Study Start Date: October 2010
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Custirsen, Docetaxel, Prednisone, OGX-011 Drug: Custirsen Sodium, Docetaxel, Prednisone
Docetaxel/Prednisone on a 3-week cycle with weekly OGX-011 640 mg infusions until disease progression, unacceptable toxicity, or completion of 10 cycles
Active Comparator: Docetaxel, Prednisone Drug: Docetaxel, Prednisone
Docetaxel/Prednisone on a 3-week cycle until disease progression, unacceptable toxicity, or completion of 10 cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age ≥ 18 years on the date of consent.
  • Histological or cytological diagnosis of adenocarcinoma of the prostate.
  • Metastatic disease on chest, abdominal, or pelvic CT and/or bone scan.
  • Systemic chemotherapy indicated due to progression while on or after androgen ablative therapy defined as:

    1. Progressive measurable disease: at least a 20% increase in the sum of the longest diameters of measurable lesions over the smallest sum observed -or- the appearance of one or more new lesions as assessed by CT scan during hormone ablation treatment. Measurable lesions are nodal or visceral soft-tissue lesions with nodal lesions ≥ 20 mm in diameter or visceral/soft-tissue lesions ≥ 10 mm in diameter (see Section 6.3.1.1 ).

      OR

    2. Bone Scan Progression: appearance of 2 or more new lesions on bone scan during hormone ablation treatment.

      OR

    3. Increasing serum PSA level: Two consecutive increases in PSA levels documented over a previous reference value obtained at least one week apart are required. If the third PSA value is less than the second, an additional fourth test to confirm a rising PSA is acceptable. A minimum starting value of 5.0 ng/mL is required for study randomization.
  • Baseline laboratory values as stated below:

    1. Creatinine ≤ 1.5 x upper limit of normal (ULN).
    2. Bilirubin ≤ 1.1 x ULN (unless elevated secondary to conditions such as Gilbert's disease).
    3. SGOT (AST) and SGPT (ALT) ≤ 1.5 x ULN.
    4. Castrate serum testosterone level (< 50 ng/dL-or-< 1.7 nmol/L).
  • Must be willing to continue primary androgen suppression with gonadotropin-releasing hormone (GnRH) analogues (either agonists or antagonists) throughout the study, unless treated with bilateral orchiectomy.
  • Adequate bone marrow function defined at screening as ANC ≥ 1.5 x 10^9 cells /L and platelet count ≥ 100 x 10^9 /L.
  • Karnofsky score ≥ 70% (see Appendix 17.2).
  • At least 28 days has 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.
  • At least 4 weeks have passed since receiving any investigational agent at the time of randomization.
  • Has recovered from any other therapy-related toxicity to ≤ grade 2, (except alopecia, anemia and any signs or symptoms of androgen deprivation therapy).
  • Patient must be willing to not add, delete or change their current bisphosphonate or denosumab usage throughout study treatment to assure that adverse event reporting is not confounded by changing their bisphosphonate or denosumab usage (unless withdrawn or changed as a result of bisphosphonate or denosumab associated toxicity).
  • Patients receiving more than 10 mg of prednisone per day (or steroid equivalent) at screening must be willing to have the dose reduced to 10 mg of prednisone per day for at least 7 days prior to randomization and maintained throughout study treatment.
  • Written informed consent must be obtained prior to any protocol-specific procedures being performed.

Exclusion Criteria

  • Received any other cytotoxic chemotherapy as treatment for prostate cancer.
  • Received any cycling, intermittent or continuous hormonal treatment 28 days prior to randomization with the exception of the continuous GnRH analogues required in Inclusion Criteria #6.
  • Participated in a prior clinical study evaluating custirsen.
  • History of or current documented brain metastasis or carcinomatous meningitis, treated or untreated. (Brain imaging for asymptomatic patients is not required.)
  • Current symptomatic cord compression requiring surgery or radiation therapy. (Once successfully treated and there has been no progression, patients are eligible for the study.) -Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring anticancer therapy or at high risk of recurrence during the study.
  • Active second malignancy (except non melanomatous skin or superficial bladder cancer) defined as requiring cancer therapy or at high risk of reoccurrence during the study
  • Uncontrolled medical conditions such as heart failure, 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01188187

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Locations
United States, Alabama
Teva Investigational Site 100
Birmingham, Alabama, United States
United States, California
Teva Investigational Site 086
Los Angeles, California, United States
Teva Investigational Site 263
Los Angeles, California, United States
Teva Investigational Site 093
Marina del Rey, California, United States
Teva Investigational Site 097
San Diego, California, United States
United States, Colorado
Teva Investigational Site 090
Fort Collins, Colorado, United States
United States, Florida
Teva Investigational Site 106
Fort Myers, Florida, United States
Teva Investigational Site 094
Port St. Lucie, Florida, United States
United States, Georgia
Teva Investigational Site 096
Atlanta, Georgia, United States
United States, Louisiana
Teva Investigational Site 103
Baton Rough, Louisiana, United States
United States, Michigan
Teva Investigational Site 098
Ann Arbor, Michigan, United States
Teva Investigational Site 112
Detroit, Michigan, United States
United States, Minnesota
Teva Investigational Site 032
Rochester, Minnesota, United States
United States, Nevada
Teva Investigational Site 204
Las Vegas, Nevada, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, South Carolina
Teva Investigational Site 266
Greensboro, South Carolina, United States
Teva Investigational Site 102
Myrtle Beach, South Carolina, United States
United States, Tennessee
Teva Investigational Site 084
Memphis, Tennessee, United States
Teva Investigational Site 101
Nashville, Tennessee, United States
United States, Texas
Teva Investigational Site 116
San Antonio, Texas, United States
Teva Investigational Site 059
Tyler, Texas, United States
Teva Investigational Site 063
Tyler, Texas, United States
United States, Virginia
Teva Investigational Site 047
Newport, Virginia, United States
Teva Investigational Site 104
Norfolk, Virginia, United States
United States, Washington
Teva Investigational Site 029
Seattle, Washington, United States
Belgium
Teva Investigational Site 862
Bonheiden, Belgium
Teva Investigational Site 860
Brussels, Belgium
Teva Investigational Site 864
Edegem, Belgium
Teva Investigational Site 863
Gent, Belgium
Canada, Alberta
Teva Investigational Site 002
Calgary, Alberta, Canada
Teva Investigational Site 023
Edmonton, Alberta, Canada
Canada, British Columbia
Teva Investigational Site 118
Abbotsford, British Columbia, Canada
Teva Investigational Site 007
Surrey, British Columbia, Canada
Teva Investigational Site 001
Vancouver, British Columbia, Canada
Teva Investigational Site 085
Victoria, British Columbia, Canada
Canada, Manitoba
Teva Investigational Site 024
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Teva Investigational Site 028
Halifax, Nova Scotia, Canada
Canada, Ontario
Teva Investigational Site 025
Hamilton, Ontario, Canada
Teva Investigational Site 108
Kingston, Ontario, Canada
Teva Investigational Site 091
Oshawa, Ontario, Canada
Teva Investigational Site 003
Ottawa, Ontario, Canada
Teva Investigational Site 004
Toronto, Ontario, Canada
Teva Investigational Site 087
Toronto, Ontario, Canada
Canada, Quebec
Teva Investigational Site 026
Montreal, Quebec, Canada
Teva Investigational Site 027
Montreal, Quebec, Canada
France
Teva Investigational Site 551
Angers Cedex 9, France
Teva Investigational Site 552
Avignon, France
Teva Investigational Site 553
Grenoble, France
Teva Investigational Site 555
La Roche-sur-Yon Cedex, France
Teva Investigational Site 557
Marseille, France
Teva Investigational Site 558
Nice Cedex 2, France
Teva Investigational Site 560
Paris Cedex 05, France
Teva Investigational Site 559
Paris Cedex 15, France
Teva Investigational Site 561
Saint Herblain Cedex, France
Teva Investigational Site 566
Saint-Brieuc Cedex, France
Teva Investigational Site 562
Saint-Priest-en-Jarez Cedex, France
Teva Investigational Site 563
Toulouse, France
Teva Investigational Site 564
Vandoeuvre-les-Nancy Cedex, France
Teva Investigational Site 550
Villejuif, France
Germany
Teva Investigational Site 607
Aachen, Germany
Teva Investigational Site 609
Berlin, Germany
Teva Investigational Site 613
Berlin, Germany
Teva Investigational Site 604
Darmstadt, Germany
Teva Investigational Site 612
Dresden, Germany
Teva Investigational Site 618
Greifswald, Germany
Teva Investigational Site 600
Hannover, Germany
Teva Investigational Site 606
Heidelberg, Germany
Teva Investigational Site 615
Heinsberg, Germany
Teva Investigational Site 611
Homburg/Saar, Germany
Teva Investigational Site 617
Kempen, Germany
Teva Investigational Site 608
Marburg, Germany
Teva Investigational Site 616
Meiningen, Germany
Teva Investigational Site 614
Muenchen, Germany
Teva Investigational Site 601
Muenster, Germany
Teva Investigational Site 602
Nuertingen, Germany
Teva Investigational Site 603
Stuttgart, Germany
Teva Investigational Site 610
Tuebingen, Germany
Teva Investigational Site 605
Wuppertal, Germany
Hungary
Teva Investigational Site 691
Budapest, Hungary
Teva Investigational Site 694
Budapest, Hungary
Teva Investigational Site 697
Debrecen, Hungary
Teva Investigational Site 692
Debrecen, Hungary
Teva Investigational Site 696
Gyor, Hungary
Teva Investigational Site 698
Miskolc, Hungary
Teva Investigational Site 699
Nyiregyhaza, Hungary
Teva Investigational Site 693
Szeged, Hungary
Teva Investigational Site 695
Veszprem, Hungary
Israel
Teva Investigational Site 506
Jerusalem, IL, Israel
Teva Investigational Site 507
Haifa, Israel
Teva Investigational Site 505
Petach Tikva, Israel
Teva Investigational Site 502
Ramat Gan, Israel
Teva Investigational Site 503
Tel Aviv, Israel
Teva Investigational Site 501
Zrifin, Israel
Italy
Teva Investigational Site 753
Arezzo, Italy
Teva Investigational Site 758
Catanzaro, Italy
Teva Investigational Site 760
Cesena (FC), Italy
Teva Investigational Site 752
Genova, Italy
Teva Investigational Site 755
Lugo (Ravenna), Italy
Teva Investigational Site 759
Meldola (FC), Italy
Teva Investigational Site 763
Milano, Italy
Teva Investigational Site 754
Napoli, Italy
Teva Investigational Site 756
Napoli, Italy
Teva Investigational Site 761
Rimini, Italy
Teva Investigational Site 762
Roma, Italy
Teva Investigational Site 750
Roma, Italy
Teva Investigational Site 764
Rozzano (MI), Italy
Teva Investigational Site 765
Verona, Italy
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 402
Seoul, Korea, Republic of
Teva Investigational Site 400
Seoul, Korea, Republic of
Teva Investigational Site 403
Seoul, Korea, Republic of
Teva Investigational Site 406
Seoul, Korea, Republic of
Teva Investigational Site 405
Yangsan-si, Korea, Republic of
Netherlands
Teva Investigational Site 851
Amsterdam, Netherlands
Teva Investigational Site 852
Rotterdam, Netherlands
Teva Investigational Site 853
Sittard-Geleen, Netherlands
Spain
Teva Investigational Site 809
Barcelona, Spain
Teva Investigational Site 808
Barcelona, Spain
Teva Investigational Site 803
Barcelona, Spain
Teva Investigational Site 816
Dos Hermanas, Spain
Teva Investigational Site 814
El Palmar, Spain
Teva Investigational Site 807
Guadalajara, Spain
Teva Investigational Site 801
Madrid, Spain
Teva Investigational Site 813
Madrid, Spain
Teva Investigational Site 800
Madrid, Spain
Teva Investigational Site 806
Madrid, Spain
Teva Investigational Site 815
Manresa, Spain
Teva Investigational Site 810
Murcia, Spain
Teva Investigational Site 811
Palma de Mallorca, Spain
Teva Investigational Site 805
Pamplona, Spain
Teva Investigational Site 804
Sabadell - Barcelona, Spain
Teva Investigational Site 802
Valencia, Spain
United Kingdom
Teva Investigational Site 704
Brighton, United Kingdom
Teva Investigational Site 701
Cambridge, United Kingdom
Teva Investigational Site 709
Coventry, United Kingdom
Teva Investigational Site 705
Guildford, Surrey, United Kingdom
Teva Investigational Site 703
Manchester, United Kingdom
Teva Investigational Site 700
Surrey, United Kingdom
Teva Investigational Site 710
Wirral, United Kingdom
Sponsors and Collaborators
Teva Pharmaceutical Industries
OncoGenex Technologies
Investigators
Study Chair: Celestia Higano, MD Seattle Cancer Care Alliance, US
Study Chair: Kim Chi, MD Vancouver Prostate Centre, BC Cancer Agency, Canada
Study Chair: Johann de Bono, Professor Institute of Cancer Research, UK
  More Information

No publications provided by Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier: NCT01188187     History of Changes
Other Study ID Numbers: OGX-011-11
Study First Received: August 23, 2010
Last Updated: April 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
custirsen sodium
prostate cancer
overall survival
Metastatic Castrate Resistant Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Prednisone
Docetaxel
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014