Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments capecitabine, cisplatin, pertuzumab, trastuzumab
Phase phase 2
Targets HER, HER2
Sponsor Hoffmann-La Roche
Start date December 2011
End date May 2016
Trial size 30 participants
Trial identifier NCT01461057, BP27836

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 patients with metastatic HER2-positive adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to two treatment arms. Patients in Arm A will receive a pertuzumab loading dose of 840 mg for Cycle 1 and a dose of 420 mg for Cycles 2-6, and patients in Arm B will receive pertuzumab 840 mg for all six cycles. Patients in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Masking open label
Primary purpose treatment
Arm
(Experimental)
fixed dosing regimen of pertuzumab 840 mg loading dose then 420 mg Q3W (plus trastuzumab, cisplatin, capecitabine)\n
capecitabine
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
cisplatin
80 mg/m2 on Day 1 of each cycle
pertuzumab
loading dose of 840 mg, then 420 mg once every three weeks
trastuzumab
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
(Experimental)
capecitabine
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
cisplatin
80 mg/m2 on Day 1 of each cycle
pertuzumab
840 mg once every three weeks
trastuzumab
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles

Primary Outcomes

Measure
Minimum (trough) pertuzumab concentration (Cmin)
time frame: Day 43
Safety (incidence of adverse events)
time frame: approximately 4 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Adult patients, >/= 18 of age - adenocarcinoma of the stomach or gastroesophageal junction with inoperable locally advanced or metastatic disease, not amenable to curative therapy - Measurable disease, according to the Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 - HER2-positive tumor - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Life expectancy of at least 3 months Exclusion Criteria: - Previous chemotherapy for advanced or metastatic disease (except (prior adjuvant or neoadjuvant therapy at least 6 months before enrollment in the study) - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome - Active (significant or uncontrolled) gastrointestinal bleeding - Abnormal laboratory values

Additional Information

Official title An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.