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

This study is currently recruiting participants.
Verified April 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01774786
First received: January 21, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
Drug: pertuzumab [Perjeta]
Drug: placebo
Drug: trastuzumab [Herceptin]
Drug: cisplatin
Drug: capecitabine
Drug: 5-fluorouracil
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival: Time from randomization to death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival: Time from randomization to first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Overall objective response (partial response + complete response) occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Duration of objective response: Time from occurrence of objective response to progressive disease, as determined by investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate: Best response of complete response or partial response or stable disease for 6 weeks or longer, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of left ventricular systolic dysfunction (symptomatic or asymptomatic) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 780
Study Start Date: June 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab + TFP Drug: pertuzumab [Perjeta]
840 mg iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)
Placebo Comparator: Placebo + TFP Drug: placebo
pertuzumab placebo iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774786

Contacts
Contact: Reference Study ID Number: BO25114 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 186 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01774786     History of Changes
Other Study ID Numbers: BO25114
Study First Received: January 21, 2013
Last Updated: April 14, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 17, 2014