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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

Tracking Information
First Submitted Date  ICMJE October 26, 2011
First Posted Date  ICMJE October 27, 2011
Results First Submitted Date  ICMJE May 19, 2016
Results First Posted Date  ICMJE June 27, 2016
Last Update Posted Date August 9, 2018
Actual Study Start Date  ICMJE December 6, 2011
Actual Primary Completion Date March 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2011)
  • Minimum (trough) pertuzumab concentration (Cmin) [ Time Frame: Day 43 ]
  • Safety (incidence of adverse events) [ Time Frame: approximately 4 years ]
Change History Complete list of historical versions of study NCT01461057 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
Official Title  ICMJE An Open-Label, Randomized, Multicenter Phase IIa Study Evaluating Pertuzumab in Combination With Trastuzumab and Chemotherapy in Patients With HER2-Positive Advanced Gastric Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date March 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czechia,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Spain
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01461057
Other Study ID Numbers  ICMJE BP27836
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date July 2018

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