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

  Show 140 Study Locations
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 01, 2014