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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

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ClinicalTrials.gov Identifier: NCT01774786
Recruitment Status : Active, not recruiting
First Posted : January 24, 2013
Results First Posted : February 14, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Gastric Cancer
Interventions: Drug: 5-Fluorouracil
Drug: Capecitabine
Drug: Cisplatin
Drug: Pertuzumab
Drug: Placebo
Drug: Trastuzumab

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The analysis included data up to a clinical data cut-off date of 9 December 2016.

Reporting Groups
  Description
Pertuzumab + Trastuzumab + Chemotherapy Participants 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.
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.

Participant Flow:   Overall Study
    Pertuzumab + Trastuzumab + Chemotherapy   Placebo + Trastuzumab + Chemotherapy
STARTED [1]   388   392 
Did Not Receive Study Drug   4   3 
Received at Least One Dose of Pertuzumab   384   1 [2] 
Received at Least One Dose of Placebo   0   388 
COMPLETED   0   0 
NOT COMPLETED   388   392 
On Treatment                55                47 
Between Treatment and Follow-up                6                2 
In Follow-up                65                62 
Death                242                262 
Lost to Follow-up                3                4 
Withdrawal by Subject                15                12 
Physician Decision                1                0 
Ineligible for Study                1                3 
[1] Intent-to-Treat (ITT) population
[2] One participant randomized to placebo arm received 1 dose of pertuzumab by error.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population included all randomized participants regardless of treatment received.

Reporting Groups
  Description
Pertuzumab + Trastuzumab + Chemotherapy Participants 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.
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.
Total Total of all reporting groups

Baseline Measures
   Pertuzumab + Trastuzumab + Chemotherapy   Placebo + Trastuzumab + Chemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 388   392   780 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (11.3)   60.1  (10.7)   60.5  (11.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      94  24.2%      69  17.6%      163  20.9% 
Male      294  75.8%      323  82.4%      617  79.1% 


  Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Baseline up to death (up to the 09 Dec 2016 data cutoff, approximately 3.5 years) ]

2.  Secondary:   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 the 09 Dec 2016 data cutoff, approximately 3.5 years) ]

3.  Secondary:   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 the 09 Dec 2016 data cutoff, approximately 3.5 years) ]

4.  Secondary:   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 the 09 Dec 2016 data cutoff, approximately 3.5 years) ]

5.  Secondary:   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 the 09 Dec 2016 data cutoff, approximately 3.5 years) ]

6.  Secondary:   Percentage of Participants With Adverse Events   [ Time Frame: Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years ]

7.  Secondary:   Percentage of Participants With Left Ventricular Systolic Dysfunction (LVSD, Symptomatic or Asymptomatic)   [ Time Frame: Baseline up to the 09 Dec 2016 data cutoff, approximately 3.5 years ]

8.  Secondary:   Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score   [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years) ]

9.  Secondary:   Change From Baseline in EORTC QLQ-Gastric Cancer Module (EORTC QLQ-STO22) Score   [ Time Frame: Day 1 of each 21-day treatment cycle up to 28 and 60-90 days (post-treatment [PT] monitoring visits 1 and 2, respectively) after Day 1 of last treatment cycle (up to approximately 3.5 years) ]

10.  Secondary:   Maximum Serum Concentration (Cmax) of Pertuzumab   [ Time Frame: Post-dose (0.5 hour after end of 30-60 minutes infusion) on Day (D1) of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years) ]

11.  Secondary:   Cmax of Trastuzumab   [ Time Frame: Post-dose (0.5 hour after end of 30-60 minutes infusion) on D1 of Cycles 1, 2, 4, and 8 (1 cycle = 21 days; up to approximately 3.5 years) ]

12.  Secondary:   Minimum Serum Concentration (Cmin) of Pertuzumab   [ Time Frame: Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years) ]

13.  Secondary:   Cmin of Trastuzumab   [ Time Frame: Pre-dose (0-6 hours before infusion) on D1 of Cycles 1, 2, 3, 4, 6, and 8; at 28 & 60-90 days (Post-Treatment [PT] Monitoring Visits 1 and 2, respectively) after D1 of last cycle (1 cycle = 21 days; up to approximately 3.5 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01774786     History of Changes
Other Study ID Numbers: BO25114
2012-003554-83 ( EudraCT Number )
First Submitted: January 21, 2013
First Posted: January 24, 2013
Results First Submitted: December 8, 2017
Results First Posted: February 14, 2018
Last Update Posted: April 13, 2018