A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
JOSHUA
An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
1 other identifier
interventional
30
8 countries
24
Brief 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 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 the Pertuzumab 840/420 mg Arm 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 the Pertuzumab 840/840 mg Arm will receive pertuzumab 840 mg for all six cycles. Participants in both treatment arms will receive trastuzumab, cisplatin, and capecitabine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 gastric-cancer
Started Dec 2011
Longer than P75 for phase_2 gastric-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
October 27, 2011
CompletedStudy Start
First participant enrolled
December 6, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedResults Posted
Study results publicly available
June 27, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2017
CompletedAugust 9, 2018
July 1, 2018
3.2 years
October 26, 2011
May 19, 2016
July 13, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Day 43 Serum Pertuzumab Trough Concentrations (Cmin) Greater Than or Equal to (>=) 20 Microgram Per Milliliter (mcg/mL)
Day 43
Number of Participants With Adverse Events (AEs)
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.
From randomization of first participant to end of study (approximately 6 years)
Study Arms (2)
Pertuzumab 840/420 mg
EXPERIMENTALParticipants 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.
Pertuzumab 840/840 mg
EXPERIMENTALParticipants 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.
Interventions
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
loading dose of 840 mg, then 420 mg once every three weeks
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Masaryk Memorial Cancer Institute; Oncological Clinic
Brno, 656 53, Czechia
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc; Onkologicka klinika
Olomouc, 779 00, Czechia
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
Prague, 150 06, Czechia
University Hospital Na Bulovce; Institut of Radiation Oncology
Prague, 180 81, Czechia
Hopital Morvan
Brest, 29200, France
CRLCC Val dAurelle Paul Lam
Montpellier, 34298, France
Hopital Robert Debre; DERMATOLOGIE
Reims, 51092, France
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Berlin, 10117, Germany
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
Braunschweig, 38114, Germany
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
Frankfurt, 60488, Germany
Klinikum Mannheim III. Medizinische Klinik
Mannheim, 68167, Germany
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
Catanzaro, Calabria, 88100, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
Milan, Lombardy, 20133, Italy
A.O. Universitaria Pisana; Oncologia
Pisa, Tuscany, 56100, Italy
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, 6229 HX, Netherlands
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
Seoul, 03080, South Korea
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
Seoul, 03722, South Korea
Asan Medical Center; Medical Oncology
Seoul, 05505, South Korea
Hospital del Mar; Servicio de Oncologia
Barcelona, 08003, Spain
Hospital Universitario La Paz; Servicio de Oncologia
Madrid, 28046, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2011
First Posted
October 27, 2011
Study Start
December 6, 2011
Primary Completion
March 1, 2015
Study Completion
October 31, 2017
Last Updated
August 9, 2018
Results First Posted
June 27, 2016
Record last verified: 2018-07