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A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01774786
First received: January 21, 2013
Last updated: May 10, 2017
Last verified: May 2017

January 21, 2013
May 10, 2017
June 10, 2013
December 9, 2016   (Final data collection date for primary outcome measure)
Overall Survival [ Time Frame: Baseline up to death (up to approximately 8.5 years) ]
Overall survival: Time from randomization to death of any cause [ Time Frame: approximately 4.5 years ]
Complete list of historical versions of study NCT01774786 on ClinicalTrials.gov Archive Site
  • Progression-Free Survival, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Percentage of Participants With Overall Objective Response, as Determined by the Investigator According to RECIST v1.1 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Duration of Objective Response, as Determined by Investigator According to RECIST v1.1 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Percentage of Participants With Clinical Benefit, as Determined by the Investigator According to RECIST v1.1 Criteria [ Time Frame: Baseline up to death or disease progression, whichever occurs first (up to approximately 8.5 years) ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to approximately 8.5 years ]
  • Percentage of Participants With Left Ventricular Systolic Dysfunction (Symptomatic or Asymptomatic) [ Time Frame: Baseline up to approximately 8.5 years ]
  • European Organization for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30) Questionnaire Score [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days after Day 1 of last treatment cycle (up to approximately 8.5 years) ]
  • EORTC QLQ-Gastric Cancer Module (EORTC QCQ-STO22) Questionnaire Score [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days after Day 1 of last treatment cycle (up to approximately 8.5 years) ]
  • European Quality of Life - 5 Dimensions (EQ-5D) Questionnaire Score [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days after Day 1 of last treatment cycle (up to approximately 8.5 years) ]
  • Maximum Serum Concentrations (Cmax) of Pertuzumab\n [ Time Frame: Pre-dose (0-6 hours [Hr] before infusion) on Day 1 (D1) of Cycles (Cy) 1, 2, 3, 4, 6, 8; 0.5 Hr after end of 30-60 minutes infusion on D1 of Cy 1, 2, 4, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Cmax of Trastuzumab [ Time Frame: Pre-dose (0-6 hours [Hr] before infusion) on Day 1 (D1) of Cycles (Cy) 1, 2, 3, 4, 6, 8; 0.5 Hr after end of 30-60 minutes infusion on D1 of Cy 1, 2, 4, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Minimum Serum Concentration (Cmin) of Pertuzumab [ Time Frame: Pre-dose (0-6 Hr before infusion) on D1 of Cy 1, 2, 3, 4, 6, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Cmin of Trastuzumab [ Time Frame: Pre-dose (0-6 Hr before infusion) on D1 of Cy 1, 2, 3, 4, 6, 8; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Pertuzumab [ Time Frame: Pre-dose (0-6 Hr before infusion) on Day 1 of Cycles 1, 3, 6; at 28 & 60-90 days after D1 of last Cy (up to approximately 8.5 years) (1 cycle = 21 days) ]
  • Progression-free survival: Time from randomization to first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ]
  • Overall objective response (partial response + complete response) occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ]
  • Duration of objective response: Time from occurrence of objective response to progressive disease, as determined by investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ]
  • Clinical benefit rate: Best response of complete response or partial response or stable disease for 6 weeks or longer, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ]
  • Safety: Incidence of left ventricular systolic dysfunction (symptomatic or asymptomatic) [ Time Frame: approximately 4.5 years ]
Not Provided
Not Provided
 
A Study of Pertuzumab in Combination With Trastuzumab and Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Gastroesophageal Junction or Gastric Cancer
Not Provided
This double-blind, placebo-controlled, randomized, multicenter, international, parallel arm study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab, fluoropyrimidine and cisplatin as first-line treatment in participants with HER2-positive metastatic gastroesophageal junction (GEJ) or gastric cancer (GC). Participants will be randomized to receive pertuzumab 840 milligrams (mg) or placebo intravenously every 3 weeks (q3w) in combination with trastuzumab (initial dose of 8 milligrams per kilogram [mg/kg] intravenously [IV] followed by 6 mg/kg IV q3w) and cisplatin and fluoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycles. Participants will continue to receive pertuzumab or placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Gastric Cancer
  • Drug: 5-Fluorouracil
    Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.
  • Drug: Capecitabine
    Participants will receive capecitabine 1000 mg/m^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.
  • Drug: Cisplatin
    Participants will receive cisplatin 80 mg/m^2 IV q3w for 6 cycles.
  • Drug: Pertuzumab
    Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
    Other Name: Perjeta
  • Drug: Placebo
    Participants will receive pertuzumab placebo IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
  • Drug: Trastuzumab
    Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
    Other Name: Herceptin
  • Experimental: Pertuzumab + Trastuzumab + Chemotherapy
    \nParticipants will receive pertuzumab in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
    Interventions:
    • Drug: 5-Fluorouracil
    • Drug: Capecitabine
    • Drug: Cisplatin
    • Drug: Pertuzumab
    • Drug: Placebo
    • Drug: Trastuzumab
  • Placebo Comparator: Placebo + Trastuzumab + Chemotherapy
    Participants will receive pertuzumab placebo in combination with trastuzumab and chemotherapy (cisplatin and fluoropyrimidine [capecitabine or 5-fluorouracil]) for the first 6 treatment cycles (cycle length = 21 days). Participants will continue to receive pertuzumab placebo and trastuzumab until disease progression occurrence of unacceptable toxicity or withdrawal from the study for another reason.
    Interventions:
    • Drug: 5-Fluorouracil
    • Drug: Capecitabine
    • Drug: Cisplatin
    • Drug: Pertuzumab
    • Drug: Placebo
    • Drug: Trastuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
780
December 15, 2021
December 9, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically confirmed metastatic adenocarcinoma of the stomach or GEJ
  • Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy greater than equal to (>/=) 3 months

Exclusion Criteria:

  • Previous cytotoxic chemotherapy for advanced (metastatic) disease
  • Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
  • Previous treatment with any HER2-directed therapy, at any time, for any duration
  • Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
  • Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to bone metastases, if recovered from all toxicities)
  • History or evidence of brain metastases
  • Clinically significant active gastrointestinal (GI) bleeding (Grade >/=2 according to National Cancer Institute [NIC]-Common Terminology Criteria for Adverse Events Version 4.0 [CTCAEv.4.0])
  • Residual toxicity resulting from previous therapy (for example, hematologic, cardiovascular, or neurologic toxicity that is Grade >/=2). Alopecia is permitted
  • Other malignancy (in addition to gastric cancer [GC]) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
  • Inadequate hematologic, renal or liver function
  • Pregnant or lactating women
  • History of congestive heart failure of any New York Heart Association (NYHA) criteria
  • Angina pectoris requiring treatment
  • Myocardial infarction within the past 6 months before the first dose of study drug
  • Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
  • History or evidence of poorly controlled hypertension
  • Baseline left ventricular ejection fraction (LVEF) value less than (<) 55 percent (%)
  • Any significant uncontrolled intercurrent systemic illness
  • Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Croatia,   El Salvador,   Finland,   Germany,   Guatemala,   Hungary,   Italy,   Japan,   Kazakhstan,   Korea, Republic of,   Macedonia, The Former Yugoslav Republic of,   Malaysia,   Mexico,   Netherlands,   Panama,   Peru,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Taiwan,   Thailand,   Turkey
 
 
NCT01774786
BO25114
2012-003554-83 ( EudraCT Number )
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2017

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