A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
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ClinicalTrials.gov Identifier: NCT01641939 |
Recruitment Status :
Terminated
First Posted : July 17, 2012
Results First Posted : August 11, 2016
Last Update Posted : May 12, 2017
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Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Gastric Cancer |
Interventions |
Drug: Taxane Drug: trastuzumab emtansine |
Enrollment | 415 |
Participant Flow
Recruitment Details | |
Pre-assignment Details | A total of 415 participants were randomized, of these 117 participants in taxane arm, 228 participants in 2.4 milligram per kilogram (mg/kg) trastuzumab emtansine arm, and 70 participants in 3.6 mg/kg trastuzumab emtansine arm received at least one dose of the treatment. |
Arm/Group Title | Standard Taxane Therapy | Trastuzumab Emtansine 2.4 mg | Trastuzumab Emtansine 3.6 mg |
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Arm/Group Description | Docetaxel was administered at 75 milligram per meter square (mg/m^2) intravenously (IV) on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. |
Period Title: Overall Study | |||
Started | 117 | 228 | 70 |
Stage 1 | 37 | 75 | 70 |
Stage 2 | 80 | 153 | 0 |
Completed | 0 | 0 | 0 |
Not Completed | 117 | 228 | 70 |
Reason Not Completed | |||
Death | 90 | 187 | 61 |
Lost to Follow-up | 3 | 2 | 1 |
Withdrawal by Subject | 14 | 11 | 5 |
Study Terminated by Sponsor | 10 | 28 | 3 |
Baseline Characteristics
Arm/Group Title | Standard Taxane Therapy | Trastuzumab Emtansine 2.4 mg | Trastuzumab Emtansine 3.6 mg | Total | |
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Arm/Group Description | Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue. | Total of all reporting groups | |
Overall Number of Baseline Participants | 117 | 228 | 70 | 415 | |
Baseline Analysis Population Description |
Intent to treat (ITT) analysis population included all randomized participants; participants grouped according to the therapy they were randomized to receive.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 117 participants | 228 participants | 70 participants | 415 participants | |
62.1 (10.3) | 60.5 (10.9) | 61.2 (11.4) | 61.1 (10.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 117 participants | 228 participants | 70 participants | 415 participants | |
Female |
22 18.8%
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51 22.4%
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17 24.3%
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90 21.7%
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Male |
95 81.2%
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177 77.6%
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53 75.7%
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325 78.3%
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Outcome Measures
Adverse Events
Limitations and Caveats
The study was terminated by the Sponsor as the primary analysis results did not meet the primary endpoint.
More Information
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
Name/Title: | Medical Communications |
Organization: | Hoffmann-LaRoche |
Phone: | 800-821-8590 |
EMail: | genentech@druginfo.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01641939 |
Other Study ID Numbers: |
BO27952 2012-000660-22 ( EudraCT Number ) |
First Submitted: | July 13, 2012 |
First Posted: | July 17, 2012 |
Results First Submitted: | June 30, 2016 |
Results First Posted: | August 11, 2016 |
Last Update Posted: | May 12, 2017 |