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A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer

NCT01461057 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-08-09

Study results available
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Summary

This randomized, multicenter, open-label study will evaluate two different doses of pertuzumab in combination with Herceptin (trastuzumab) and chemotherapy in the first-line treatment of participants with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to two treatment arms. Participants in the Pertuzumab 840/420 mg Arm will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and participants in the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

Conditions

Interventions

DRUG

Capecitabine

1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle

DRUG

Cisplatin

80 mg/m2 on Day 1 of each cycle

DRUG

Pertuzumab

loading dose of 840 mg, then 420 mg once every three weeks

DRUG

Pertuzumab

840 mg once every three weeks

DRUG

Trastuzumab

loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-06
Primary Completion
2015-03-01
Completion
2017-10-31

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • South Korea
  • Spain

Study Locations

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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 NCT01461057 on ClinicalTrials.gov