Overview

This trial is active, not recruiting.

Conditions fallopian tube cancer, ovarian cancer, peritoneal cancer
Treatments amg 386, paclitaxel, amg 386 placebo, carboplatin
Phase phase 3
Target ANG
Sponsor Amgen
Start date January 2012
End date March 2016
Trial size 1015 participants
Trial identifier NCT01493505, 20101129, TRINOVA-3 20101129/ENGOT-ov2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
amg 386 placebo
AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
(Active Comparator)
amg 386
AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
paclitaxel
Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
carboplatin
Carboplatin AUC 5 or 6 IV Q3W (6 cycles)

Primary Outcomes

Measure
Progression free survival
time frame: 3 years

Secondary Outcomes

Measure
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
Incidence of anti-AMG 386 antibody formation
time frame: 4 years
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Amgen.