Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005484
Recruitment Status : Terminated (Study terminated due to slow patient recruitment.)
First Posted : December 9, 2013
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Gastric Cancer
Intervention Drug: Trastuzumab
Enrollment 6
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description Participants received trastuzumab at an initial dose of 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Period Title: Overall Study
Started 6
Completed 2
Not Completed 4
Reason Not Completed
Death             1
Disease progression             1
Changed to a Different Study             1
Sponsor decision             1
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: all participants who signed informed consent for the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
62.49  (9.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
1
  16.7%
Male
5
  83.3%
1.Primary Outcome
Title Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
Hide Description Tumor response assessed according to RECIST. Complete response (CR): complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis less than [<]10 millimeters [mm]); no new lesions. Partial response (PR): greater than or equal to (≥)30 percent (%) decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable disease (SD): not qualifying for CR, PR, or progressive disease (PD). Participants who could not be classified per RECIST were allocated as follows: early death from malignant disease (death due to cancer), early death because of other cause (death not related to toxicity or cancer disease), and unknown (for not fitting into the above categories).
Time Frame Weekly throughout study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description:
Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage of participants
CR 0
PR 33.3
SD 0
PD 50.0
Early death from malignant disease 0
Early death because of other cause 16.7
Unknown 0
2.Secondary Outcome
Title Percentage of Participants With Clinical Benefit
Hide Description Participants were classified as having a clinical benefit if they had a best overall tumor response of CR, PR, or SD. Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions. Stable SD: not qualifying for CR, PR, or PD.
Time Frame Weekly throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description:
Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage participants
33.3
3.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of CR or PR
Hide Description Tumor response assessed according to RECIST. CR: complete disappearance of all target and non-target lesions, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis <10 mm); no new lesions. PR: ≥30% decrease under baseline of sum of diameters of all target lesions. Short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions; no unequivocal progression of non-target disease; no new lesions.
Time Frame Weekly throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description:
Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: percentage participants
33.3
4.Secondary Outcome
Title Overall Survival - Number of Participants Who Died
Hide Description OS was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
Time Frame Weekly throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description:
Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
2
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival (OS) was defined as the time, in months, from the date of study entry to the date of the death due to any cause. If a participant's date of death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
Time Frame Weekly throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description:
Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: months
6.39
(1.4 to 18.7)
6.Secondary Outcome
Title Time to Progression - Number of Participants With an Event
Hide Description Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
Time Frame Weekly throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description:
Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Participants Analyzed 6
Measure Type: Number
Unit of Measure: participants
5
7.Secondary Outcome
Title Time to Progression
Hide Description Time to progression was defined as the time, in months, from the date of study entry to the date of disease progression or death due to any cause. If a participant's date of disease progression or death was unknown, or had not occurred, the last date of examination, treatment, and follow-up dates were included in the analysis.
Time Frame Weekly throughout the study
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description:
Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
Overall Number of Participants Analyzed 6
Median (Full Range)
Unit of Measure: months
1.78
(1.4 to 7.4)
Time Frame Weekly throughout the study.
Adverse Event Reporting Description All participants who received at least 1 dose of study treatment were included in the safety analysis population.
 
Arm/Group Title Trastuzumab Monotherapy
Hide Arm/Group Description Participants received trastuzumab via IV infusion once weekly at an initial dose of 4 mg/kg at Visit 1, and 2 mg/kg at each subsequent visit for a maximum of 33 visits.
All-Cause Mortality
Trastuzumab Monotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Trastuzumab Monotherapy
Affected / at Risk (%)
Total   3/6 (50.00%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage * 1  1/6 (16.67%) 
Oesophageal haemorrhage * 1  1/6 (16.67%) 
General disorders   
General physical health deterioration * 1  1/6 (16.67%) 
Immune system disorders   
Hypersensitivity * 1  1/6 (16.67%) 
Metabolism and nutrition disorders   
Hyperkalaemia * 1  1/6 (16.67%) 
Renal and urinary disorders   
Renal failure * 1  1/6 (16.67%) 
Surgical and medical procedures   
Stent placement * 1  1/6 (16.67%) 
Oesophageal stent insertion * 1  1/6 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Not specified
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Trastuzumab Monotherapy
Affected / at Risk (%)
Total   6/6 (100.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  3/6 (50.00%) 
Ascites * 1  1/6 (16.67%) 
Constipation * 1  1/6 (16.67%) 
Diarrhoea * 1  2/6 (33.33%) 
Dysphagia * 1  1/6 (16.67%) 
Flatulence * 1  1/6 (16.67%) 
Nausea * 1  3/6 (50.00%) 
Retching * 1  1/6 (16.67%) 
Vomiting * 1  1/6 (16.67%) 
Oesophageal fistula * 1  1/6 (16.67%) 
General disorders   
Chills * 1  2/6 (33.33%) 
Fatigue * 1  1/6 (16.67%) 
Hyperhidrosis * 1  1/6 (16.67%) 
Oedema * 1  1/6 (16.67%) 
Oedema peripheral * 1  1/6 (16.67%) 
Pyrexia * 1  2/6 (33.33%) 
Hepatobiliary disorders   
Cholelithiasis * 1  1/6 (16.67%) 
Immune system disorders   
Hypersensitivity * 1  1/6 (16.67%) 
Infections and infestations   
Onychomycosis * 1  1/6 (16.67%) 
Urinary tract infection * 1  1/6 (16.67%) 
Injury, poisoning and procedural complications   
Contusion * 1  1/6 (16.67%) 
Investigations   
Gamma-glutamyltransferase increased * 1  1/6 (16.67%) 
Metabolism and nutrition disorders   
Hyponatraemia * 1  1/6 (16.67%) 
Musculoskeletal and connective tissue disorders   
Flank pain * 1  1/6 (16.67%) 
Nervous system disorders   
Paresthesia * 1  1/6 (16.67%) 
Peripheral sensory neuropathy * 1  1/6 (16.67%) 
Renal and urinary disorders   
Pollakiuria * 1  1/6 (16.67%) 
Urinary retention * 1  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/6 (16.67%) 
Dyspnoea * 1  1/6 (16.67%) 
Pleural effusion * 1  1/6 (16.67%) 
Surgical and medical procedures   
Stent removal * 1  1/6 (16.67%) 
Vascular disorders   
Hypertension * 1  1/6 (16.67%) 
Venous thrombosis * 1  1/6 (16.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Not specified
Due to slow patient recruitment, the study was prematurely terminated.
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02005484     History of Changes
Other Study ID Numbers: ML17263
First Submitted: December 4, 2013
First Posted: December 9, 2013
Results First Submitted: June 9, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014