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Terminated/Withdrawn
Sponsor ID
20101129

TRINOVA-3: A study of AMG 386 or AMG 386 Placebo in combination with paclitaxel and carboplatin to treat ovarian cancer

Sponsor ID
20101129
Clinicaltrials.gov ID
NCT01493505
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
AMG 386
Type
Interventional
Masking
Triple (Participant, Care Provider, Investigator)
Enrollment
1015
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression free survival

Timeframe: 3 years

Secondary Outcome Measures

Overall survival (OS)

Timeframe: 5 years

Incidence of adverse events and significant laboratory abnormalities

Timeframe: 4 years

Pharmacokinetics of AMG 386 (Cmax and Cmin)

Timeframe: 1 year

Incidence of anti-AMG 386 antibody formation

Timeframe: 4 years

Patient reported ovarian cancer-specific symptoms and health related quality of life

Timeframe: 4 years

Patient reported status as measured by the EuroQOL (EQ-5D)

Timeframe: 4 years

AMG 386 exposure-response relationships for PFS and OS

Timeframe: 4 years

Correlation of serum biomarkers with measures of response

Timeframe: 4 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Rancho Mirage, CA, United States, 92270
Status
Recruiting
Location
Research Site
Ogden, UT, United States, 84403
Status
Recruiting
Location
Research Site
Austin, TX, United States, 78731
Status
Recruiting
Location
Research Site
Winston Salem, NC, United States, 27103
Status
Recruiting
Location
Research Site
Hollywood, FL, United States, 33021
Status
Recruiting
Location
Research Site
Dallas, TX, United States, 75246
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Fallopian Tube Cancer
    • Show more
  • Ovarian Cancer
  • Peritoneal Cancer
    • Sex
    Assigned Female at Birth
    Trial Dates
    Jan 2012 - Mar 2016
    Inclusion and Exclusion 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