TRINOVA-2: Trebananib in Ovarian Cancer-2

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01281254
First received: January 20, 2011
Last updated: April 8, 2014
Last verified: April 2014

January 20, 2011
April 8, 2014
March 2011
October 2014   (final data collection date for primary outcome measure)
To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by progression-free survival, defined as the time from randomization to the earliest of the dates of first radiologic disease progression per RECIST 1.1 with modifications [ Time Frame: Radiological imaging will be performed 8 weeks ± 1 week, starting from date of randomization for the first 64 weeks, then every 16 weeks ± 1 week for the next 32 weeks, and then every 24 weeks ± 4 weeks thereafter. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01281254 on ClinicalTrials.gov Archive Site
• To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival [ Time Frame: weekly ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
TRINOVA-2: Trebananib in Ovarian Cancer-2
A Phase 3, Randomized, Double-Blind Trial of Pegylated Liposomal Doxorubicin (PLD) Plus AMG 386 or Placebo in Women With Recurrent Partially Platinum Sensitive or Resistant Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

To determine if AMG 386 plus pegylated liposomal doxorubicin (PLD) is superior to placebo plus PLD as measured by progression-free survival (PFS)

The hypothesis for this study is that AMG 386 plus PLD will prolong PFS compared to placebo plus PLD in women with recurrent partially platinum sensitive or resistant epithelial ovarian, primary peritoneal or fallopian tube cancer.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Drug: AMG386 plus PLD
    AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
  • Drug: Placebo plus PLD

    Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug.

    PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)

  • Placebo Comparator: Placebo plus PLD
    Arm B: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)
    Intervention: Drug: Placebo plus PLD
  • Experimental: AMG386 plus PLD
    Arm A: PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
    Intervention: Drug: AMG386 plus PLD
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
223
May 2019
October 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically documented invasive epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Radiographically documented disease progression either on or following the last dose of the prior regimen for epithelial ovarian, primary peritoneal, or fallopian tube cancer
  • Subjects must have had one prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound.
  • Female 18 years of age or older at the time the written informed consent is obtained
  • Adequate organ and hematological function

Exclusion Criteria:

  • Subjects who have received more than 3 previous regimens of anti cancer therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
  • Subjects treated with prior pegylated liposomal doxorubicin (PLD) or any anthracycline-based or mitoxantrone-based chemotherapy
  • Subjects with primary platinum-refractory disease
  • Subjects with platinum-free interval (PFI) > 12 months from their last platinum based therapy
  • History of central nervous system metastasis
  • Major surgery within 28 days prior to randomization or still recovering from prior surgery
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Germany,   Hong Kong,   Hungary,   Italy,   New Zealand,   Poland,   Singapore,   Slovakia,   Switzerland,   Taiwan,   United Kingdom
 
NCT01281254
20060517, 2009-017946-30, ENGOT-ov-6, TRINOVA-2, 20060517
Yes
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP