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A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

NCT01774786 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 780

Last updated 2020-12-30

Study results available
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Summary

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram \[mg/kg\] intravenously \[IV\] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.

Conditions

Interventions

DRUG

5-Fluorouracil

Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m\^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.

DRUG

Capecitabine

Participants will receive capecitabine 1000 mg/m\^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.

DRUG

Cisplatin

Participants will receive cisplatin 80 mg/m\^2 IV q3w for 6 cycles.

DRUG

Pertuzumab

Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

DRUG

Placebo

Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

DRUG

Trastuzumab

Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-10
Primary Completion
2016-12-09
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • China
  • Croatia
  • El Salvador
  • Finland
  • Germany
  • Guatemala
  • Hungary
  • Italy
  • Japan
  • Kazakhstan
  • Malaysia
  • Mexico
  • Netherlands
  • North Macedonia
  • Panama
  • Peru
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01774786 on ClinicalTrials.gov