Study Complete
Sponsor ID
20090508

TRINOVA-1: A Study of AMG 386 or placebo, in Combination With Weekly Paclitaxel Chemotherapy, as Treatment for Ovarian Cancer, Primary Peritoneal Cancer and Fallopian Tube Cancer

Sponsor ID
20090508
Clinicaltrials.gov ID
NCT01204749
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to determine if treatment with paclitaxel plus AMG 386 is superior to paclitaxel plus placebo in women with recurrent partially platinum sensitive or resistant epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer.

AMG 386 is a man-made medication that is designed to stop the development of blood vessels in cancer tissues. Cancer tissues rely on the development of new blood vessels, a process called angiogenesis, to obtain a supply of oxygen and nutrients to grow.

Additional Study Details

Phase
Phase 3
Product
AMG 386
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
919
Additional Study Details

Protocol Summary

Primary Outcome Measures

Progression-Free Survival

Timeframe: 8 Months on average

Secondary Outcome Measures

Overall survival

Timeframe: 20 months on average

Objective Response Rate

Timeframe: From Baseline (if subject has Measurable Disease) until objective response (radiologic)

Duration of response

Timeframe: From Baseline until progression

CA-125 response rate per Gynecologic Cancer Intergroup (GCIG) and change in CA-125

Timeframe: From Baseline until CA-125 response

Incidence of adverse events and significant laboratory abnormalities

Timeframe: 8 Months on average

Pharmacokinetics of AMG 386 (Cmax and Cmin)

Timeframe: Week 1 until week 9 of treatment

Incidence of the occurrence of anti-AMG 386 antibody formation

Timeframe: Week 1 until maximum of 1-year following last dose of study drug

Patient reported Health Related Quality of Life (HRQOL) and ovarian cancer related symptoms using Functional Assessment of Cancer Therapy – Ovary questionnaire (FACT-O)

Timeframe: From week 1 until 30-days following last study drug administration

Overall health status using EuroQOL(EQ-5D)

Timeframe: From week 1 until 30-days following last study drug administration

Study Documents

Study Synopsis
Available Language(s): English

Locations

Location
Status
Contact Us
Location
Research Site
Greenslopes, QLD, Australia, 4120
Status
Recruiting
Location
Research Site
Malvern, VIC, Australia, 3144
Status
Recruiting
Location
Research Site
Bentleigh East, VIC, Australia, 3165
Status
Recruiting
Location
Research Site
Bendigo, VIC, Australia, 3550
Status
Completed
Location
Research Site
Plovdiv, Bulgaria, 4004
Status
Recruiting
Location
Research Site
Stara Zagora, Bulgaria, 6003
Status
Recruiting
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