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A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTROESOPHAGEAL JUNCTION OR GASTRIC CANCER


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

Thank you

Trial Information

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTROESOPHAGEAL JUNCTION OR GASTRIC CANCER


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction

- Measurable or evaluable non-measurable disease as assessed by the investigator
according to RECIST v1.1 criteria

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Life expectancy >/= 3 months

Exclusion Criteria:

- Previous cyctotoxic chemotherapy for advanced (metastatic) disease

- Evidence of disease progression documented within 6 months after completion of prior
neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ
adenocarcinoma

- Previous treatment with any HER2-directed therapy, at any time, for any duration

- Previous exposure to any investigational treatment within 30 days before the first
dose of study treatment

- Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks
if given as palliation to peripheral bone metastases, if recovered from all
toxicities)

- History or evidence of brain metastases

- Clinically significant active GI bleeding (Grade >/= 2 according to NIC-CTCAEv.4.03)

- Other malignancy (in addition to GC) within 5 years before enrollment, except for
carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that
has been previously treated with curative intent

- Inadequate hematologic, renal or liver function

- Pregnant or lactating women

- History of congestive heart failure of any New York Heart Association (NYHA) criteria

- Angina pectoris requiring treatment

- Myocardial infarction within the past 6 months before the first dose of study drug

- Clinically significant valvular heart disease or uncontrollable high-risk cardiac
arrhythmia

- History or evidence of poorly controlled hypertension

- Baseline left ventricular ejection fraction (LVEF) value < 55%

- Any significant uncontrolled intercurrent systemic illness

- Positive for hepatitis B, hepatitis C or HIV infection

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival: Time from randomization to death of any cause

Outcome Time Frame:

approximately 4.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

BO25114

NCT ID:

NCT01774786

Start Date:

April 2013

Completion Date:

June 2015

Related Keywords:

  • Gastric Cancer
  • Stomach Neoplasms

Name

Location

Hinsdale, Illinois  60521
Alexandria, Minnesota  56308
Albany, New York  12208
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Denver, Colorado  
Indianapolis, Indiana  
Charleston, South Carolina  
Las Vegas, Nevada  89109