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 19, 2016
Last verified: May 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Randomization of first participant to clinical cutoff date (01 March 2015) (approximately 41 months) ] [ Designated as safety issue: No ]
    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 2011
Estimated Study Completion Date: May 2019
Primary Completion Date: March 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)
Genders Eligible for Study:   Both
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
Bruxelles, Belgium, 1200
Leuven, Belgium, 3000
Czech Republic
Brno, Czech Republic, 656 53
Hradec Kralove, Czech Republic, 500 05
Olomouc, Czech Republic, 775 20
Praha 5, Czech Republic, 150 06
Praha 8, Czech Republic, 180 81
France
Brest, France, 29200
Montpellier cedex 5, France, 34298
Reims, France, 51092
Germany
Berlin, Germany, 10117
Braunschweig, Germany, 38114
Frankfurt, Germany, 60488
Mannheim, Germany, 68167
Italy
Catanzaro, Calabria, Italy, 88100
Milano, Lombardia, Italy, 20133
Pisa, Toscana, Italy, 56100
Korea, Republic of
Seoul, Korea, Republic of, 03080
Seoul, Korea, Republic of, 03722
Seoul, Korea, Republic of, 05505
Netherlands
Maastricht, Netherlands, 6229 HX
Spain
Barcelona, Spain, 08003
Madrid, Spain, 28046
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 19, 2016
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on August 30, 2016