AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)

• ClinicalTrials.gov Identifier: NCT01281254
• Recruitment Status: Terminated
• First Posted: January 21, 2011
• Last Update Posted: December 2, 2017
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: January 20, 2011
• First Posted Date: January 21, 2011
• Last Update Posted Date: December 2, 2017
• Actual Study Start Date: April 18, 2011
• Actual Primary Completion Date: August 29, 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 20, 2011): 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. ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 20, 2011): • To determine if AMG 386 plus PLD is superior to placebo plus PLD as measured by overall survival [ Time Frame: weekly ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AMG 386 (Trebananib) in Ovarian Cancer (TRINOVA-2)
• Official Title: 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

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal Cancer

Intervention

• 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)

Study Arms

• 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

• Publications *: Marth C, Vergote I, Scambia G, Oberaigner W, Clamp A, Berger R, Kurzeder C, Colombo N, Vuylsteke P, Lorusso D, Hall M, Renard V, Pignata S, Kristeleit R, Altintas S, Rustin G, Wenham RM, Mirza MR, Fong PC, Oza A, Monk BJ, Ma H, Vogl FD, Bach BA. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. Eur J Cancer. 2017 Jan;70:111-121. doi: 10.1016/j.ejca.2016.09.004. Epub 2016 Dec 1.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 5, 2013): 223
• Original Estimated Enrollment (submitted: January 20, 2011): 380
• Actual Study Completion Date: April 19, 2017
• Actual Primary Completion Date: August 29, 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, Hungary, Italy, New Zealand, Poland, Singapore, Slovakia, Switzerland, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT01281254
• Other Study ID Numbers: 20060517; 2009-017946-30 ( EudraCT Number ); ENGOT-ov-6; TRINOVA-2 ( Other Identifier: Amgen, Inc ); 20060517 ( Other Identifier: Amgen. Inc. )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Amgen
• Original Responsible Party: Global Development Leader, Amgen Inc.
• Current Study Sponsor: Amgen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: MD; Amgen

• PRS Account: Amgen
• Verification Date: November 2017