Trial Outcomes & Findings for A Study of Herceptin (Trastuzumab) in Patients With Metastatic or Advanced Gastric Cancer With Disease Progression (NCT NCT02005484)

NCT ID: NCT02005484

Last Updated: 2014-08-11

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: Weekly throughout study
• Results posted on: 2014-08-11

Participant Flow

Participant milestones

Measure	Trastuzumab Monotherapy 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.
Overall Study STARTED	6
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Trastuzumab Monotherapy 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.
Overall Study Death	1
Overall Study Disease progression	1
Overall Study Changed to a Different Study	1
Overall Study Sponsor decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Trastuzumab Monotherapy n=6 Participants 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.
Age, Continuous	62.49 years STANDARD_DEVIATION 9.79 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weekly throughout study

Population: ITT population

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).

Outcome measures

Measure	Trastuzumab Monotherapy n=6 Participants 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.
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category CR	0 percentage of participants
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category PR	33.3 percentage of participants
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category SD	0 percentage of participants
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category PD	50.0 percentage of participants
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category Early death from malignant disease	0 percentage of participants
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category Early death because of other cause	16.7 percentage of participants
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category Unknown	0 percentage of participants

SECONDARY outcome

Timeframe: Weekly throughout the study

Population: ITT population

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.

Outcome measures

Measure	Trastuzumab Monotherapy n=6 Participants 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.
Percentage of Participants With Clinical Benefit	33.3 percentage participants

SECONDARY outcome

Timeframe: Weekly throughout the study

Population: ITT population

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.

Outcome measures

Measure	Trastuzumab Monotherapy n=6 Participants 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.
Percentage of Participants With a Best Overall Response of CR or PR	33.3 percentage participants

SECONDARY outcome

Timeframe: Weekly throughout the study

Population: ITT population

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.

Outcome measures

Measure	Trastuzumab Monotherapy n=6 Participants 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 Survival - Number of Participants Who Died	2 participants

SECONDARY outcome

Timeframe: Weekly throughout the study

Population: ITT population

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.

Outcome measures

Measure	Trastuzumab Monotherapy n=6 Participants 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 Survival	6.39 months Interval 1.4 to 18.7

SECONDARY outcome

Timeframe: Weekly throughout the study

Population: ITT population

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.

Outcome measures

Measure	Trastuzumab Monotherapy n=6 Participants 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.
Time to Progression - Number of Participants With an Event	5 participants

SECONDARY outcome

Timeframe: Weekly throughout the study

Population: ITT population

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.

Outcome measures

Measure	Trastuzumab Monotherapy n=6 Participants 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.
Time to Progression	1.78 months Interval 1.4 to 7.4

Adverse Events

Trastuzumab Monotherapy

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Trastuzumab Monotherapy n=6 participants at risk 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.
Gastrointestinal disorders Gastrointestinal haemorrhage	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders General physical health deterioration	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Metabolism and nutrition disorders Hyperkalaemia	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Renal and urinary disorders Renal failure	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Surgical and medical procedures Stent placement	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Surgical and medical procedures Oesophageal stent insertion	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Oesophageal haemorrhage	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Immune system disorders Hypersensitivity	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.

Other adverse events

Measure	Trastuzumab Monotherapy n=6 participants at risk 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.
Gastrointestinal disorders Abdominal pain	50.0% 3/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Ascites	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Constipation	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Dysphagia	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Flatulence	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Nausea	50.0% 3/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Retching	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Gastrointestinal disorders Oesophageal fistula	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Chills	33.3% 2/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Fatigue	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Hyperhidrosis	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Oedema	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Oedema peripheral	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
General disorders Pyrexia	33.3% 2/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Hepatobiliary disorders Cholelithiasis	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Immune system disorders Hypersensitivity	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Infections and infestations Onychomycosis	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Infections and infestations Urinary tract infection	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Injury, poisoning and procedural complications Contusion	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Investigations Gamma-glutamyltransferase increased	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Metabolism and nutrition disorders Hyponatraemia	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Musculoskeletal and connective tissue disorders Flank pain	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Nervous system disorders Paresthesia	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Renal and urinary disorders Pollakiuria	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Renal and urinary disorders Urinary retention	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Surgical and medical procedures Stent removal	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Vascular disorders Hypertension	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.
Vascular disorders Venous thrombosis	16.7% 1/6 • Weekly throughout the study. All participants who received at least 1 dose of study treatment were included in the safety analysis population.

Additional Information

Medical Communications

Hoffman-LaRoche

Phone: 800-821-8590

Email: genentech@druginfo.com

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