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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01493505
First received: September 29, 2011
Last updated: June 2, 2014
Last verified: June 2014

September 29, 2011
June 2, 2014
January 2012
May 2016   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01493505 on ClinicalTrials.gov Archive Site
  • Overall survival (OS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events and significant laboratory abnormalities [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics of AMG 386 (Cmax and Cmin) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    pre-dose weeks 1, 10, 19
  • Patient reported ovarian cancer-specific symptoms and health related quality of life [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Patient reported status as measured by the EuroQOL (EQ-5D) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • AMG 386 exposure-response relationships for PFS and OS [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Correlation of serum biomarkers with measures of response [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
TRINOVA-3: A Study of AMG 386 or AMG 386 Placebo in Combination With Paclitaxel and Carboplatin to Treat Ovarian Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cancer
  • 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)
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Paclitaxel
    • Drug: AMG 386 Placebo
    • Drug: Carboplatin
  • Active Comparator: AMG 386
    Interventions:
    • Drug: AMG 386
    • Drug: Paclitaxel
    • Drug: Carboplatin
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
1015
July 2020
May 2016   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Belgium,   Canada,   Denmark,   Germany,   Greece,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Russian Federation,   Spain
 
NCT01493505
20101129, TRINOVA-3 20101129/ENGOT-ov2
Not Provided
Amgen
Amgen
Not Provided
Study Director: MD Amgen
Amgen
June 2014

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