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

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ClinicalTrials.gov Identifier: NCT01461057
Recruitment Status : Completed
First Posted : October 27, 2011
Results First Posted : June 27, 2016
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

October 26, 2011
October 27, 2011
May 19, 2016
June 27, 2016
August 9, 2018
December 6, 2011
March 1, 2015   (Final data collection date for primary outcome measure)
  • 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: From randomization of first participant to end of study (approximately 6 years) ]
    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.
  • Minimum (trough) pertuzumab concentration (Cmin) [ Time Frame: Day 43 ]
  • Safety (incidence of adverse events) [ Time Frame: approximately 4 years ]
Complete list of historical versions of study NCT01461057 on ClinicalTrials.gov Archive Site
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A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastric Cancer
  • 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: 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
  • 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.
    Interventions:
    • Drug: Capecitabine
    • Drug: Cisplatin
    • Drug: Pertuzumab
    • Drug: Trastuzumab
  • 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.
    Interventions:
    • Drug: Capecitabine
    • Drug: Cisplatin
    • Drug: Pertuzumab
    • Drug: Trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Same as current
October 31, 2017
March 1, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Spain
Czech Republic
 
NCT01461057
BP27836
No
Not Provided
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP