A Phase 2 interventional study of Trastuzumab in Gastric Cancer, sponsored by Hoffmann-La Roche. Terminated at 12 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-11.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This study will evaluate the efficacy and safety of Herceptin in patients with metastatic or advanced gastric cancer with disease progression during platinum-based or 5-fluoropyrimidine-based chemotherapy. The anticipated time on study treatment is until disease progression.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 6 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Initial dose of 4 milligrams (mg) per (/) kilogram (kg) by body weight (BW), followed by 2 mg/kg BW at each subsequent visit
Drug: Trastuzumab
4 mg/kg initial dose, followed by 2 mg/kg
Also known as: Herceptin
Percentage of Participants With a Response by Response Evaluation Criteria In Solid Tumors (RECIST) Category
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
Percentage of Participants With Clinical Benefit
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
Percentage of Participants With a Best Overall Response of CR or PR
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
Overall Survival - Number of Participants Who Died
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
Overall Survival
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
Time to Progression - Number of Participants With an Event
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
Time to Progression
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
| Milestone | Trastuzumab Monotherapy |
|---|---|
| Started | 6 |
| Completed | 2 |
| Not completed | 4 |
| Withdrew: Death | 1 |
| Withdrew: Disease progression | 1 |
| Withdrew: Changed to a different study | 1 |
| Withdrew: Sponsor decision | 1 |
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).
| percentage of participants | Trastuzumab Monotherapy |
|---|---|
| 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 |
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.
| percentage participants | Trastuzumab Monotherapy |
|---|---|
| Percentage of Participants With Clinical Benefit | 33.3 |
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.
| percentage participants | Trastuzumab Monotherapy |
|---|---|
| Percentage of Participants With a Best Overall Response of CR or PR | 33.3 |
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.
| participants | Trastuzumab Monotherapy |
|---|---|
| Overall Survival - Number of Participants Who Died | 2 |
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.
| months | Trastuzumab Monotherapy |
|---|---|
| Overall Survival | 6.39 (1.4 to 18.7) |
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.
| participants | Trastuzumab Monotherapy |
|---|---|
| Time to Progression - Number of Participants With an Event | 5 |
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.
| months | Trastuzumab Monotherapy |
|---|---|
| Time to Progression | 1.78 (1.4 to 7.4) |
Collected over Weekly throughout the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Trastuzumab Monotherapy | — | 3/6 (50%) | 6/6 (100%) |
| Event | Trastuzumab Monotherapy |
|---|---|
| Gastrointestinal haemorrhageGastrointestinal disorders | 1/6 |
| General physical health deteriorationGeneral disorders | 1/6 |
| HyperkalaemiaMetabolism and nutrition disorders | 1/6 |
| Renal failureRenal and urinary disorders | 1/6 |
| Stent placementSurgical and medical procedures | 1/6 |
| Oesophageal stent insertionSurgical and medical procedures | 1/6 |
| Oesophageal haemorrhageGastrointestinal disorders | 1/6 |
| HypersensitivityImmune system disorders | 1/6 |
| Event | Trastuzumab Monotherapy |
|---|---|
| Abdominal painGastrointestinal disorders | 3/6 |
| NauseaGastrointestinal disorders | 3/6 |
| DiarrhoeaGastrointestinal disorders | 2/6 |
| ChillsGeneral disorders | 2/6 |
| PyrexiaGeneral disorders | 2/6 |
| AscitesGastrointestinal disorders | 1/6 |
| ConstipationGastrointestinal disorders | 1/6 |
| DysphagiaGastrointestinal disorders | 1/6 |
| FlatulenceGastrointestinal disorders | 1/6 |
| RetchingGastrointestinal disorders | 1/6 |
Intent-to-treat (ITT) population: all participants who signed informed consent for the study.
| Age, Continuous(years) | Trastuzumab Monotherapy |
|---|---|
| Mean | 62.49 ± 9.79 |
| Sex: Female, Male(Participants) | Trastuzumab Monotherapy |
|---|---|
| Female | 1 |
| Male | 5 |
This study is terminated, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche