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History of Changes for Study: NCT01493505
A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
Latest version (submitted February 22, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 15, 2011 None (earliest Version on record)
2 January 4, 2012 Study Status and Contacts/Locations
3 January 10, 2012 Contacts/Locations, Study Status and Study Identification
4 January 18, 2012 Contacts/Locations and Study Status
5 April 2, 2012 Study Status and Contacts/Locations
6 April 30, 2012 Contacts/Locations and Study Status
7 May 17, 2012 Study Status and Contacts/Locations
8 May 24, 2012 Contacts/Locations and Study Status
9 June 1, 2012 Sponsor/Collaborators, Study Status and Contacts/Locations
10 June 8, 2012 Sponsor/Collaborators, Contacts/Locations and Study Status
11 June 14, 2012 Contacts/Locations and Study Status
12 July 13, 2012 Sponsor/Collaborators, Contacts/Locations and Study Status
13 July 20, 2012 Contacts/Locations and Study Status
14 August 9, 2012 Study Status
15 September 14, 2012 Contacts/Locations and Study Status
16 October 1, 2012 Contacts/Locations and Study Status
17 October 5, 2012 Contacts/Locations and Study Status
18 November 5, 2012 Study Status and Contacts/Locations
19 November 13, 2012 Contacts/Locations and Study Status
20 January 9, 2013 Contacts/Locations and Study Status
21 January 17, 2013 Contacts/Locations and Study Status
22 February 26, 2013 Study Status and Contacts/Locations
23 March 6, 2013 Study Status and Contacts/Locations
24 March 14, 2013 Contacts/Locations and Study Status
25 May 6, 2013 Contacts/Locations and Study Status
26 May 14, 2013 Contacts/Locations and Study Status
27 May 23, 2013 Contacts/Locations and Study Status
28 May 30, 2013 Contacts/Locations and Study Status
29 June 10, 2013 Study Status and Contacts/Locations
30 June 12, 2013 Study Status
31 June 26, 2013 Contacts/Locations and Study Status
32 August 1, 2013 Study Status and Contacts/Locations
33 August 15, 2013 Contacts/Locations and Study Status
34 August 28, 2013 Contacts/Locations and Study Status
35 September 4, 2013 Study Status and Contacts/Locations
36 September 11, 2013 Contacts/Locations and Study Status
37 September 26, 2013 Contacts/Locations and Study Status
38 October 16, 2013 Study Status and Contacts/Locations
39 October 30, 2013 Contacts/Locations and Study Status
40 November 6, 2013 Study Status and Contacts/Locations
41 November 13, 2013 Contacts/Locations and Study Status
42 November 20, 2013 Contacts/Locations and Study Status
43 January 2, 2014 Contacts/Locations and Study Status
44 January 8, 2014 Contacts/Locations and Study Status
45 January 22, 2014 Contacts/Locations and Study Status
46 February 19, 2014 Contacts/Locations and Study Status
47 June 2, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
48 September 19, 2014 Study Status
49 September 8, 2015 Study Status
50 October 12, 2015 Study Status
51 December 3, 2015 Study Status
52 January 12, 2016 Study Status
53 April 6, 2016 Study Status
54 November 14, 2016 Study Status
55 January 5, 2017 Recruitment Status and Study Status
56 January 20, 2017 References and Study Status
57 February 22, 2017 Recruitment Status, Study Status and Arms and Interventions
Comparison Format:
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Study NCT01493505
Submitted Date:  December 15, 2011 (v1)
Open or close this module Study Identification
Unique Protocol ID: 20101129
Brief Title: 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
Secondary IDs: TRINOVA-3 20101129/ENGOT-ov2
Open or close this module Study Status
Record Verification: December 2011
Overall Status: Recruiting
Study Start: February 2012
Primary Completion: May 2016 [Anticipated]
Study Completion: July 2020 [Anticipated]
First Submitted: September 29, 2011
First Submitted that
Met QC Criteria:		 December 15, 2011
First Posted: December 16, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:		 December 15, 2011
Last Update Posted: December 16, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Amgen
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cancer
Keywords: Primary Peritoneal Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 2000 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Placebo Comparator: Placebo 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)
Active Comparator: AMG 386 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: Carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression free survival
[ Time Frame: 3 years ]
Secondary Outcome Measures:
1. Overall survival (OS)
[ Time Frame: 5 years ]
2. Incidence of adverse events and significant laboratory abnormalities
[ Time Frame: 4 years ]
3. 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
4. Incidence of anti-AMG 386 antibody formation
[ Time Frame: 4 years ]

pre-dose weeks 1, 10, 19
5. Patient reported ovarian cancer-specific symptoms and health related quality of life
[ Time Frame: 4 years ]
6. Patient reported status as measured by the EuroQOL (EQ-5D)
[ Time Frame: 4 years ]
7. AMG 386 exposure-response relationships for PFS and OS
[ Time Frame: 4 years ]
8. Correlation of serum biomarkers with measures of response
[ Time Frame: 4 years ]
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Amgen Call Center
Telephone: 866-572-6436
Study Officials: MD
Study Director
Amgen
Locations: Spain, Comunidad Valenciana
Research Site
[Recruiting]
Valencia, Comunidad Valenciana, Spain, 46009
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: AmgenTrials clinical trials website
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services