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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Cisplatin
Pertuzumab
Pertuzumab
Trastuzumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cliniques Universitaires St-Luc
  • UZ Leuven Gasthuisberg
  • Masaryk Memorial Cancer Institute; Oncological Clinic
  • Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
  • Fakultni nemocnice Olomouc; Onkologicka klinika
  • Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
  • University Hospital Na Bulovce; Institut of Radiation Oncology
  • Hopital Morvan
  • CRLCC Val dAurelle Paul Lam
  • Hopital Robert Debre; DERMATOLOGIE
  • Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
  • Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
  • Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
  • Klinikum Mannheim III. Medizinische Klinik
  • Campus Universitario S.Venuta; Centro Oncologico T.Campanella
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • A.O. Universitaria Pisana; Oncologia
  • Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
  • Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
  • Asan Medical Center; Medical Oncology
  • Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
  • Hospital del Mar; Servicio de Oncologia
  • Hospital Universitario La Paz; Servicio de Oncologia
  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pertuzumab 840/420 mg

Pertuzumab 840/840 mg

Arm Description

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.

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.

Outcomes

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)
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.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2011
Last Updated
July 13, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01461057
Brief Title
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Acronym
JOSHUA
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
December 6, 2011 (Actual)
Primary Completion Date
March 1, 2015 (Actual)
Study Completion Date
October 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pertuzumab 840/420 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Pertuzumab 840/840 mg
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
80 mg/m2 on Day 1 of each cycle
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
loading dose of 840 mg, then 420 mg once every three weeks
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
840 mg once every three weeks
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin
Intervention Description
loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
Primary Outcome Measure Information:
Title
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
Title
Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
From randomization of first participant to end of study (approximately 6 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Masaryk Memorial Cancer Institute; Oncological Clinic
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni Nemocnice Hradec Kralove; Dept of Radiotherapy & Oncology
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Fakultni nemocnice Olomouc; Onkologicka klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultní Nemocnice V Motole; Radioterapeuticko-Onkologicke Oddeleni
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
University Hospital Na Bulovce; Institut of Radiation Oncology
City
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Facility Name
Hopital Morvan
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CRLCC Val dAurelle Paul Lam
City
Montpellier cedex 5
ZIP/Postal Code
34298
Country
France
Facility Name
Hopital Robert Debre; DERMATOLOGIE
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Klinikum Braunschweig; Medizinische Klinik III; Klinik für Hämatologie und Onkologie
City
Braunschweig
ZIP/Postal Code
38114
Country
Germany
Facility Name
Krankenhaus Nordwest; Klinik f. Onkologie und Hämatologie
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Facility Name
Klinikum Mannheim III. Medizinische Klinik
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Campus Universitario S.Venuta; Centro Oncologico T.Campanella
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
A.O. Universitaria Pisana; Oncologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Yonsei Medical Center; Dept. of Medicine , Division of Hemato-Oncology
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center; Medical Oncology
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Hospital del Mar; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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