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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01461057
First received: October 26, 2011
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
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 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 participants in Arm B will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.

Condition Intervention Phase
Gastric Cancer Drug: Capecitabine Drug: Cisplatin Drug: Pertuzumab Drug: Trastuzumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL) [ Time Frame: Day 43 ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Randomization of first participant to clinical cutoff date (01 March 2015) (approximately 41 months) ]
    An adverse event (AE) was defined as any untoward medical occurrence in a participant administered the investigational product which does not necessarily have a causal relationship with this treatment.


Enrollment: 30
Study Start Date: December 6, 2011
Estimated Study Completion Date: September 30, 2017
Primary Completion Date: March 1, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab 840/420 mg
Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
Drug: Capecitabine
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
Other Name: Xeloda
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
Other Name: Perjeta
Drug: Trastuzumab
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
Other Name: Herceptin
Experimental: Pertuzumab 840/840 mg
Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
Drug: Capecitabine
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
Other Name: Xeloda
Drug: Cisplatin
80 mg/m2 on Day 1 of each cycle
Drug: Pertuzumab
840 mg once every three weeks
Other Name: Perjeta
Drug: Trastuzumab
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
Other Name: Herceptin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult participants, greater than or equal to (>=) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461057

Locations
Belgium
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000
Czechia
Masaryk Memorial Cancer Institute; Oncological Clinic
Brno, Czechia, 656 53
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Kralove, Czechia, 500 05
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, Czechia, 779 00
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
Praha 5, Czechia, 150 06
University Hospital Na Bulovce; Institut of Radiation Oncology
Praha 8, Czechia, 180 81
France
Hopital Morvan
Brest, France, 29200
CRLCC Val dAurelle Paul Lam
Montpellier cedex 5, France, 34298
Hopital Robert Debre; DERMATOLOGIE
Reims, France, 51092
Germany
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Berlin, Germany, 10117
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
Braunschweig, Germany, 38114
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, Germany, 60488
Klinikum Mannheim III. Medizinische Klinik
Mannheim, Germany, 68167
Italy
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, Italy, 88100
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milano, Lombardia, Italy, 20133
A.O. Universitaria Pisana; Oncologia
Pisa, Toscana, Italy, 56100
Korea, Republic of
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, Korea, Republic of, 03080
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
Seoul, Korea, Republic of, 03722
Asan Medical Center; Medical Oncology
Seoul, Korea, Republic of, 05505
Netherlands
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, Netherlands, 6229 HX
Spain
Hospital del Mar; Servicio de Oncologia
Barcelona, Spain, 08003
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, Spain, 28046
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, Spain, 46010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01461057     History of Changes
Other Study ID Numbers: BP27836
Study First Received: October 26, 2011
Results First Received: May 19, 2016
Last Updated: May 30, 2017

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Pertuzumab
Cisplatin
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 23, 2017