Trial Outcomes & Findings for A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer (NCT NCT01641939)

NCT ID: NCT01641939

Last Updated: 2017-05-12

Results Overview

Overall survival was defined as the time between the date of randomization and date of death due to any cause. Kaplan-Meier estimates were used for analysis. Participants for whom no death was reported prior to an analysis cutoff (30 June 2015) was censored at the latest date before the cutoff in which they were known to be alive. All data from the standard taxane therapy and trastuzumab emtansine 2.4 mg (selected treatment arm) from phase 2 and phase 3 (Stage 2) are combined into phase 3 data, and thus cumulative data are provided within the results presented for phase 3. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

415 participants

Primary outcome timeframe

Date of randomization until death (up to 2 years 3 months)

Results posted on

2017-05-12

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Standard Taxane Therapy 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 2.4 mg 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 3.6 mg 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.
Overall Study STARTED	117	228	70
Overall Study Stage 1	37	75	70
Overall Study Stage 2	80	153	0
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	117	228	70

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Taxane Therapy 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 2.4 mg 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 3.6 mg 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.
Overall Study Death	90	187	61
Overall Study Lost to Follow-up	3	2	1
Overall Study Withdrawal by Subject	14	11	5
Overall Study Study Terminated by Sponsor	10	28	3

Baseline Characteristics

A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Taxane Therapy n=117 Participants 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 2.4 mg n=228 Participants 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 3.6 mg n=70 Participants 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 n=415 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 10.3 • n=93 Participants	60.5 years STANDARD_DEVIATION 10.9 • n=4 Participants	61.2 years STANDARD_DEVIATION 11.4 • n=27 Participants	61.1 years STANDARD_DEVIATION 10.8 • n=483 Participants
Sex: Female, Male Female	22 Participants n=93 Participants	51 Participants n=4 Participants	17 Participants n=27 Participants	90 Participants n=483 Participants
Sex: Female, Male Male	95 Participants n=93 Participants	177 Participants n=4 Participants	53 Participants n=27 Participants	325 Participants n=483 Participants

PRIMARY outcome

Timeframe: Date of randomization until death (up to 2 years 3 months)

Population: ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=117 Participants 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 2.4 mg n=228 Participants 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 2.4 mg 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.
Overall Survival (OS)- Phase 3	8.6 months Interval 7.1 to 11.2	7.9 months Interval 6.7 to 9.5	—

PRIMARY outcome

Timeframe: Date of randomization until death (up to 1 year)

Population: Analysis population included all participants that had been enrolled in phase 2 (stage 1) up to a clinical cut-off date of 10 August 2013; participants grouped according to the therapy they were randomized to receive. Here, N (number of participants analyzed)=number of evaluable participants during phase 2 up to 10 August 2013.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=30 Participants 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 2.4 mg n=58 Participants 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 2.4 mg n=64 Participants 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.
Overall Survival (OS) - Phase 2 (Dose Selection Portion of the Study)	28.0 weeks Interval 24.0 to The upper limit of the 95% CI could not be calculated due to the large number of censored events.	23.0 weeks Interval 18.0 to The upper limit of the 95% CI could not be calculated due to the large number of censored events.	36.3 weeks Interval 23.0 to The upper limit of the 95% CI could not be calculated due to the large number of censored events.

SECONDARY outcome

Timeframe: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

Population: ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.

Progressive disease could base on symptom deterioration or was defined as at least a 20 percent (%) increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Tumor assessment was performed using modified RECIST v1.1. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=117 Participants 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 2.4 mg n=228 Participants 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 2.4 mg 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.
Percentage of Participants With Disease Progression or Death According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3	88.9 percentage participants	93.0 percentage participants	—

SECONDARY outcome

Timeframe: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

Population: ITT population included all randomized participants; participants grouped according to the therapy they were randomized to receive.

Progression-free survival was defined as the time between the date of randomization and the first date of documented progression or date of death due to any cause, whichever occurred first. Tumor assessment was performed using modified RECIST v1.1. Progressive disease could base on symptom deterioration or was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the appearance of one or more new lesions and/or the unequivocal progression of existing non-target lesions. Kaplan-Meier estimates were used for analysis. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure. The confirmatory analyses are restricted to comparisons between the taxane arm and the selected trastuzumab emtansine arm (2.4 mg).

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=117 Participants 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 2.4 mg n=228 Participants 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 2.4 mg 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.
Progression Free Survival (PFS) According to Modified Response Evaluation Criteria in Solid Tumors (mRECIST v1.1) - Phase 3	2.89 months Interval 2.76 to 4.01	2.66 months Interval 1.61 to 2.79	—

SECONDARY outcome

Timeframe: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

Population: ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with measurable disease were included in analysis of this outcome measure.

Objective response referred to participants with complete response (CR) or partial response (PR). CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: greater than or equal to (\>=) 30% decrease in sum of the longest diameter (LD) of all target lesions taking as reference the screening sum LD. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=102 Participants 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 2.4 mg n=204 Participants 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 2.4 mg 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.
Percentage of Participants With Objective Response According to mRECIST v1.1 - Phase 3	19.6 percentage of participants Interval 12.56 to 28.07	20.6 percentage of participants Interval 15.26 to 26.45	—

SECONDARY outcome

Timeframe: Date of randomization until disease progression or death, whichever occurred first (assessed at baseline, every 6 weeks up to 2 years 3 months)

DOR: time from the date when a clinical response \[CR or PR\] was first documented to the date of first documented progressive disease (PD) or death. CR:disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: \>= 30% decrease in sum of the LD of all target lesions taking as reference the screening sum LD. PD: could base on symptom deterioration or at least a 20% increase in the sum of diameters of target or non-target lesions and new lesions, taking as reference the smallest sum on study (nadir), including baseline. To be assigned a status of PR or CR, changes in tumor measurements had to be confirmed by repeat assessments that should have been performed no less than 4 weeks after the criteria for response were first met. Longer intervals as determined by the study protocol were also appropriate. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=102 Participants 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 2.4 mg n=204 Participants 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 2.4 mg 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.
Duration of Objective Response (DOR) - Phase 3	3.65 months Interval 2.76 to 5.55	4.27 months Interval 3.02 to 6.83	—

SECONDARY outcome

Timeframe: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up (up to 2 years 3 months)

Population: ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.

The EORTC QLQ-C30 is a validated, cancer-specific 30-item patient-reported measure, and contains 14 domains to assess the impact of cancer treatment on 5 aspects of participants functioning (physical, role, cognitive, emotional, and social), 9 aspects of disease/treatment-related symptoms (fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation, diarrhea) and a global QoL/overall health status scale. Questions used 4 point scale (1 'Not at all' to 4 'Very much'; with the exception of the QoL/health status scale which uses a 7-point scale (1 'very poor' to 7 'Excellent'). Each scale is transformed on a scale of 0-100; a higher score equals (=) a better level of functioning or greater degree of symptoms. Change of greater than or equal to (\>=) 10-points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=91 Participants 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 2.4 mg n=189 Participants 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 2.4 mg 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.
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Global Health Status/QoL	44.0 percentage of participants Interval 33.56 to 54.75	34.4 percentage of participants Interval 27.65 to 41.36	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Appetite loss	39.6 percentage of participants Interval 29.57 to 50.0	30.2 percentage of participants Interval 23.97 to 37.23	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Cognitive Functioning	31.9 percentage of participants Interval 22.49 to 42.0	28.0 percentage of participants Interval 21.76 to 34.68	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Constipation	40.7 percentage of participants Interval 30.48 to 51.47	25.9 percentage of participants Interval 19.84 to 32.66	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Diarrhoea	23.1 percentage of participants Interval 14.89 to 32.53	21.7 percentage of participants Interval 16.23 to 28.15	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Dyspnea	19.8 percentage of participants Interval 12.16 to 29.19	21.7 percentage of participants Interval 16.23 to 28.15	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Emotional Functioning	24.2 percentage of participants Interval 15.98 to 33.56	29.1 percentage of participants Interval 22.74 to 35.78	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Fatigue	46.2 percentage of participants Interval 36.17 to 56.92	40.7 percentage of participants Interval 33.67 to 47.81	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Nausea/Vomiting	33.0 percentage of participants Interval 24.04 to 43.08	28.0 percentage of participants Interval 21.76 to 34.68	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Pain	49.5 percentage of participants Interval 38.8 to 60.14	33.9 percentage of participants Interval 27.36 to 40.84	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Physical Functioning	17.6 percentage of participants Interval 10.4 to 26.44	25.9 percentage of participants Interval 19.84 to 32.66	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Role Functioning	29.7 percentage of participants Interval 20.55 to 39.86	30.7 percentage of participants Interval 24.2 to 37.75	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Social Functioning	34.1 percentage of participants Interval 24.45 to 44.16	37.6 percentage of participants Interval 30.8 to 44.48	—
Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC QLQ-C30) Score - Phase 3 Insomnia	33.0 percentage of participants Interval 24.04 to 43.08	33.3 percentage of participants Interval 26.83 to 40.32	—

SECONDARY outcome

Timeframe: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)

Population: ITT population included all randomized participants, participants grouped according to the therapy they were randomized to receive. Here, N=number of participants with baseline and at least one post-baseline valid score.

The Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) supplements the EORTC QLQ-C30 to assess symptoms and treatment-related side effects commonly reported in participants. There are 22 questions which comprise 5 scales (dysphagia, pain, reflux symptom, dietary restrictions, and anxiety) and 4 single items (dry mouth, hair loss, taste, body image). Most questions use 4-point scale (1 'Not at all' to 4 'Very much'; 1 question was a yes or no answer). A linear transformation was used to standardize all scores and single-items to a scale of 0 to 100; higher score=better level of functioning or greater degree of symptoms. Change of \>=10 points has been found to be clinically significant. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=90 Participants 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 2.4 mg n=185 Participants 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 2.4 mg 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.
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Overall	88.9 percentage of participants Interval 81.15 to 94.54	88.1 percentage of participants Interval 82.64 to 92.4	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Body image	20.0 percentage of participants Interval 12.31 to 29.33	29.7 percentage of participants Interval 23.25 to 36.52	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Dry Mouth	30.0 percentage of participants Interval 20.79 to 40.35	21.1 percentage of participants Interval 15.44 to 27.28	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Dietary Restrictions	41.1 percentage of participants Interval 30.84 to 51.98	32.4 percentage of participants Interval 25.75 to 39.66	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Dysphagia	35.6 percentage of participants Interval 25.74 to 45.8	23.8 percentage of participants Interval 17.84 to 30.31	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Hair Loss	11.1 percentage of participants Interval 5.46 to 18.85	22.7 percentage of participants Interval 17.07 to 29.29	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Pain/discomfort	52.2 percentage of participants Interval 41.43 to 62.45	45.4 percentage of participants Interval 38.28 to 52.87	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Specific Emotional Problems	63.3 percentage of participants Interval 53.09 to 73.25	57.8 percentage of participants Interval 50.71 to 65.05	—
Percentage of Participants With Clinically Significant Improvement in Quality of Life Questionnaire Stomach Cancer Module 22 (QLQ-STO22) Score - Phase 3 Upper Gastrointestinal Symptoms	46.7 percentage of participants Interval 36.52 to 57.49	42.7 percentage of participants Interval 35.47 to 50.0	—

SECONDARY outcome

Timeframe: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)

AGC symptomatic progression: a worsening of \>=10-points in any 1 of the abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and/or weight loss scales of the EORTC QLQ-C30 and QLQ-STO22. QLQ-STO22 supplements EORTC QLQ-C30 to assess symptoms and commonly reported treatment-related side effects. There are 22 questions comprise 5 scales (dysphagia, pain, reflux symptom, diet restrictions, anxiety), 4 single items (dry mouth, hair loss, taste, body image), which are related to the symptoms of the disease. Most questions used 4-point scale (1 'Not at all' to 4 'Very much'). All scores and single-items transformed to a scale of 0-100; higher score=better level of functioning or greater degree of symptoms. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=117 Participants 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 2.4 mg n=228 Participants 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 2.4 mg 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.
Percentage of Participants With Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3	90.6 percentage of participants	93.0 percentage of participants	—

SECONDARY outcome

Timeframe: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at survival follow-up (up to 2 years 3 months)

Time to AGC symptom were defined as the time from randomization to the first documentation of an increase in at least one of the pre-specified abdominal discomfort, loss of appetite, weakness and fatigue, upper abdominal pain, change in bowel movement, and weight loss subscales of the QLQ STO22 and EORTC QLQ-C30. Cumulative data (up to primary analysis cut-off date of 30-June-2015) are provided for both phase 2 and phase 3 within the results of this measure.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=117 Participants 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 2.4 mg n=228 Participants 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 2.4 mg 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.
Time to Advanced Gastric Cancer (AGC) Symptom Progression - Phase 3	1.61 months Interval 1.41 to 2.17	1.51 months Interval 1.41 to 1.64	—

SECONDARY outcome

Timeframe: Day 1 (D1) of Cycle 1 (C1) and C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

Population: Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.

Maximum observed plasma concentration of Trastuzumab Emtansine (T-DM1) and total trastuzumab were reported. Stage 1 consists of all participants recruited before the regimen selection, which was carried out after 12 weeks of randomization.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=41 Participants 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 2.4 mg n=37 Participants 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 2.4 mg 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.
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1 T-DM1 Cycle 1 First Dose (n=41, 37)	43.0 microgram per milliliter (mcg/mL) Standard Deviation 11.8	58.6 microgram per milliliter (mcg/mL) Standard Deviation 12.9	—
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1 T-DM1 Cycle 4 First Dose (n=25, 10)	52.6 microgram per milliliter (mcg/mL) Standard Deviation 19.4	61.6 microgram per milliliter (mcg/mL) Standard Deviation 14.5	—
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1 Total trastuzumab Cycle 1 First Dose (n=41, 37)	46.8 microgram per milliliter (mcg/mL) Standard Deviation 12.3	61.2 microgram per milliliter (mcg/mL) Standard Deviation 14.6	—
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 1 Total trastuzumab Cycle 4 First Dose (n=25, 10)	71.2 microgram per milliliter (mcg/mL) Standard Deviation 23.2	66.3 microgram per milliliter (mcg/mL) Standard Deviation 14.7	—

SECONDARY outcome

Timeframe: C1D1 and C1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

Population: Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.

Maximum observed plasma concentration of DM1 were reported. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=40 Participants 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 2.4 mg n=35 Participants 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 2.4 mg 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.
Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1 DM1 Cycle 1 First Dose (n=40, 35)	2.47 nanogram per milliliter (mcg/mL) Standard Deviation 1.05	4.61 nanogram per milliliter (mcg/mL) Standard Deviation 6.26	—
Maximum Observed Plasma Concentration (Cmax) of N2'-Deacetyl-N2'-(3-mercapto-1-oxopropyl)-Maytansine (DM1) - Stage 1 DM1 Cycle 4 First Dose (n=22, 9)	3.41 nanogram per milliliter (mcg/mL) Standard Deviation 1.61	3.86 nanogram per milliliter (mcg/mL) Standard Deviation 0.83	—

SECONDARY outcome

Timeframe: C1D1; C4D1

Population: Participants who had at least one PK parameter estimated were included for analysis. Here, n=number of participants evaluable at specified timepoint.

Stage 2 consists of all participants recruited after the regimen selection decision up to primary data cut-off date 30-June-2015.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=57 Participants 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 2.4 mg 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 2.4 mg 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.
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2 T-DM1 Cycle 1 First Dose (n=56)	34.1 mcg/mL Standard Deviation 15.2	—	—
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2 T-DM1 Cycle 4 First Dose (n=26)	38.0 mcg/mL Standard Deviation 13.4	—	—
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2 Total trastuzumab Cycle 1 First Dose (n=57)	44.5 mcg/mL Standard Deviation 15.4	—	—
Maximum Observed Plasma Concentration (Cmax) of Trastuzumab Emtansine (T-DM1) and Total Trastuzumab - Stage 2 Total trastuzumab Cycle 4 First Dose (n=26)	69.7 mcg/mL Standard Deviation 21.3	—	—

SECONDARY outcome

Timeframe: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

Population: Participants who had at least one PK parameter estimated were included for analysis.

AUCinf= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=41 Participants 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 2.4 mg n=37 Participants 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 2.4 mg 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.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1 T-DM1	179 day*mcg/mL Standard Deviation 51.0	262 day*mcg/mL Standard Deviation 90.3	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUCinf] - Stage 1 Total trastuzumab	289 day*mcg/mL Standard Deviation 129	403 day*mcg/mL Standard Deviation 237	—

SECONDARY outcome

Timeframe: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

Population: Participants who had at least one PK parameter estimated were included for analysis.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=41 Participants 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 2.4 mg n=37 Participants 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 2.4 mg 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.
Plasma Decay Half-Life (t1/2) - Stage 1 T-DM1	3.48 days Standard Deviation 0.747	3.33 days Standard Deviation 1.21	—
Plasma Decay Half-Life (t1/2) - Stage 1 Total trastuzumab	5.22 days Standard Deviation 1.53	5.40 days Standard Deviation 2.15	—

SECONDARY outcome

Timeframe: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

Population: Participants who had at least one PK parameter estimated were included for analysis.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=41 Participants 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 2.4 mg n=37 Participants 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 2.4 mg 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.
Volume of Distribution at Steady State (Vss) - Stage 1 T-DM1	66.2 milliliter per kilogram (mL/kg) Standard Deviation 19.2	67.7 milliliter per kilogram (mL/kg) Standard Deviation 14.0	—
Volume of Distribution at Steady State (Vss) - Stage 1 Total trastuzumab	65.9 milliliter per kilogram (mL/kg) Standard Deviation 21.9	72.1 milliliter per kilogram (mL/kg) Standard Deviation 16.1	—

SECONDARY outcome

Timeframe: D1C1 and D1C4, C1D2, C1D3, C1D4/C1D5, C1D8, C1D15, C2D1 (up to 12 weeks)

Population: Participants who had at least one PK parameter estimated were included for analysis.

CL is a quantitative measure of the rate at which a drug substance is removed from the body. Stage 1 consists of all participants recruited before the regimen selection decision. Regimen selection analysis was carried out after 12 weeks of randomization.

Outcome measures

Outcome measures
Measure	Standard Taxane Therapy n=41 Participants 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 2.4 mg n=37 Participants 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 2.4 mg 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.
Systemic Clearance (CL) - Stage 1 T-DM1	14.6 mL/day/kg Standard Deviation 4.64	15.4 mL/day/kg Standard Deviation 5.61	—
Systemic Clearance (CL) - Stage 1 Total trastuzumab	10.2 mL/day/kg Standard Deviation 4.87	11.3 mL/day/kg Standard Deviation 5.46	—

Adverse Events

Standard Taxane Therapy

Serious events: 31 serious events

Other events: 105 other events

Deaths: 0 deaths

Trastuzumab Emtansine 2.4 mg

Serious events: 65 serious events

Other events: 211 other events

Deaths: 0 deaths

Trastuzumab Emtansine 3.6 mg

Serious events: 23 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Medical Communications

Hoffmann-LaRoche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER