TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer

• ClinicalTrials.gov Identifier: NCT01493505
• Recruitment Status: Terminated
• First Posted: December 16, 2011
• Last Update Posted: February 23, 2017
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

Tracking Information

• First Submitted Date: September 29, 2011
• First Posted Date: December 16, 2011
• Last Update Posted Date: February 23, 2017
• Study Start Date: January 2012
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 15, 2011): Progression free survival [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 15, 2011)

• Overall survival (OS) [ Time Frame: 5 years ]
• Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 4 years ]
• Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: 1 year ]
  pre-dose weeks 1, 7, 10, 19 and within 10 minutes post dose week 1, 7
• Incidence of anti-AMG 386 antibody formation [ Time Frame: 4 years ]
  pre-dose weeks 1, 10, 19
• Patient reported ovarian cancer-specific symptoms and health related quality of life [ Time Frame: 4 years ]
• Patient reported status as measured by the EuroQOL (EQ-5D) [ Time Frame: 4 years ]
• AMG 386 exposure-response relationships for PFS and OS [ Time Frame: 4 years ]
• Correlation of serum biomarkers with measures of response [ Time Frame: 4 years ]

• 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: TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
• Official Title: A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers
• Brief Summary: The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Fallopian Tube Cancer
• Ovarian Cancer
• Peritoneal Cancer

Intervention

• Drug: AMG 386
  AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
• Drug: Paclitaxel
  Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
• Drug: AMG 386 Placebo
  AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
• Drug: Carboplatin
  Carboplatin AUC 5 or 6 IV Q3W (6 cycles)

Study Arms

• Placebo Comparator: Placebo
  Placebo Paclitaxel Carboplatin
  Interventions:

  • Drug: Paclitaxel
  • Drug: AMG 386 Placebo
  • Drug: Carboplatin
• Active Comparator: AMG 386
  AMG 386 Paclitaxel Carboplatin
  Interventions:

  • Drug: AMG 386
  • Drug: Paclitaxel
  • Drug: Carboplatin

Publications *

• Fujiwara K, Monk BJ, Lhomme C, Coleman RL, Brize A, Oaknin A, Ray-Coquard I, Fabbro M, Provencher D, Bamias A, Vergote I, DeCensi A, Zhang K, Vogl FD, Bach BA, Raspagliesi F. Health-related quality of life in women with recurrent ovarian cancer receiving paclitaxel plus trebananib or placebo (TRINOVA-1). Ann Oncol. 2016 Jun;27(6):1006-1013. doi: 10.1093/annonc/mdw147. Epub 2016 Mar 30.
• Vergote I, Scambia G, O'Malley DM, Van Calster B, Park SY, Del Campo JM, Meier W, Bamias A, Colombo N, Wenham RM, Covens A, Marth C, Raza Mirza M, Kroep JR, Ma H, Pickett CA, Monk BJ; TRINOVA-3/ENGOT-ov2/GOG-3001 investigators. Trebananib or placebo plus carboplatin and paclitaxel as first-line treatment for advanced ovarian cancer (TRINOVA-3/ENGOT-ov2/GOG-3001): a randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 Jun;20(6):862-876. doi: 10.1016/S1470-2045(19)30178-0. Epub 2019 May 7.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: June 2, 2014): 1015
• Original Estimated Enrollment (submitted: December 15, 2011): 2000
• Actual Study Completion Date: December 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Female subjects 18 years of age or older with FIGO Stages III-IV epithelial ovarian, primary peritoneal or fallopian tube cancer with an indication for first-line treatment with paclitaxel and carboplatin x 6 cycles (Subjects with pseudomyxoma, mesothelioma, adenocarcinoma with an unknown primary tumour, carcinosarcoma, sarcoma, mucinous or neuroendocrine histology are excluded
• Subjects with FIGO Stage IIIA or IIIB disease must have undergone PDS for ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization
• Subjects with FIGO Stage IIIC or IV disease must either:
• Undergo PDS for epithelial ovarian, primary peritoneal or fallopian tube cancer within 12 weeks prior to randomization or
• Plan to have IDS following 3 cycles of paclitaxel and carboplatin plus AMG 386 or AMG 386 placebo for biopsy proven epithelial ovarian, primary peritoneal or fallopian tube cancer
• ECOG performance status of 0 or 1
• Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

• Prior use of any anticancer therapy or experimental therapy for epithelial ovarian, primary peritoneal or fallopian tube cancer
• Previous abdominal and/or pelvic external beam radiotherapy
• History of central nervous metastasis
• History of arterial or venous thromboembolism within 12 months prior to randomization
• Clinically significant cardiovascular disease within 12 months prior to randomization

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: Austria, Belgium, Canada, Denmark, Germany, Greece, Hong Kong, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Spain, United States

Administrative Information

• NCT Number: NCT01493505
• Other Study ID Numbers: 20101129; TRINOVA-3 20101129/ENGOT-ov2
• Has Data Monitoring Committee: Not Provided
• 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: February 2017