A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIITreatment18 and overBO25114
NCI-2014-00612, NCI-2014-00613, NCT01774786

Trial Description

Summary

This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm

study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with

Herceptin (trastuzumab), fluoropyrimidine and cisplatin as first-line treatment in patients

with HER2-positive metastatic gastroesophageal junction or gastric cancer. Patients will be

randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in

combination with Herceptin (initial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks)

and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6

treatment cycles. Patients will continue to receive Perjeta or placebo and Herceptin until

disease progression or unacceptable toxicity occurs.

Eligibility Criteria

Inclusion Criteria:

Life expectancy >/= 3 months

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

Measurable or evaluable non-measurable disease as assessed by the investigator

according to RECIST v1.1 criteria

HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction

Adult patients, >/= 18 years of age

Exclusion Criteria:

Positive for hepatitis B, hepatitis C or HIV infection

Any significant uncontrolled intercurrent systemic illness

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

History or evidence of poorly controlled hypertension

Clinically significant valvular heart disease or uncontrollable high-risk cardiac

arrhythmia

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

Angina pectoris requiring treatment

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

Pregnant or lactating women

Inadequate hematologic, renal or liver function

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

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

History or evidence of brain metastases

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)

Previous exposure to any investigational treatment within 30 days before the first

dose of study treatment

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

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 cyctotoxic chemotherapy for advanced (metastatic) disease

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

Hoffmann-La Roche

    Trial Sites

    U.S.A.

    Illinois
    Chicago

    University of Chicago Comprehensive Cancer Center

    Daniel Virgil Thomas Catenacci
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01774786

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.