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

Phase 3

Terminated

• Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cancer
• Interventions: Drug: AMG 386; Drug: Paclitaxel; Drug: AMG 386 Placebo; Drug: Carboplatin

• Registration Number: NCT01493505
• Lead Sponsor: Amgen

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 available

Study Timeline

• Study First Submitted: 2011-09-29
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-16
• Study Start: 2012-01
• Primary Completion: 2016-03
• Disposition First Submitted: 2016-11-14
• Disposition First Submitted QC: 2016-11-14
• Disposition First Posted: 2016-11-15
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1015

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	AMG 386 Placebo	Placebo Paclitaxel Carboplatin
AMG 386	AMG 386	AMG 386 Paclitaxel Carboplatin
AMG 386	Carboplatin	AMG 386 Paclitaxel Carboplatin
Placebo	Carboplatin	Placebo Paclitaxel Carboplatin
Placebo	Paclitaxel	Placebo Paclitaxel Carboplatin
AMG 386	Paclitaxel	AMG 386 Paclitaxel Carboplatin

Primary Outcome Measures

Name	Time	Method
Progression free survival	3 years

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years
Patient reported status as measured by the EuroQOL (EQ-5D)	4 years
AMG 386 exposure-response relationships for PFS and OS	4 years
Incidence of adverse events and significant laboratory abnormalities	4 years
Patient reported ovarian cancer-specific symptoms and health related quality of life	4 years
Pharmacokinetics of AMG 386 (Cmax and Cmin)	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	4 years	pre-dose weeks 1, 10, 19
Correlation of serum biomarkers with measures of response	4 years

Trial Locations

Locations (1)

Research Site; 🇪🇸 Madrid, Spain