Trial · NCT00680901
LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
NCT00680901, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2013-10-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib. Trials, record NCT00680901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00680901
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
- NCT number
- NCT00680901
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 545 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Neoplasms, Gastrointestinal Tract
- Interventions
- Lapatinib, Placebo, Capecitabine, Oxaliplatin
- First posted
- 2008-05-20
- Last updated
- 2025-08-07
- Other registries' IDs
- eudract:2007-005725-29
- Results first posted
- 2013-10-29
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival at the Time of Primary Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. |
| Primary | Overall Survival in All Randomized Participants at the Time of Primary Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. |
| Secondary | Overall Survival at the Time of Final Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Overall Survival was defined as the time from randomization to death from any cause. Participants who had not died were censored at their follow-up visit, either because follow-up had ended or was still ongoing. |
| Secondary | Progression Free Survival (PFS) | From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Progression-Free Survival (PFS) was defined as the time from randomization to the earliest occurrence of disease progression or death from any cause. Per RECIST v1.0, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants with symptomatic progression, even without radiological confirmation, were also counted. Those who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Participants who received non-study anti-cancer therapies before progression were also censored. |
| Secondary | Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | A participant was considered a responder if they had achieved either a complete response (CR), defined as the disappearance of all target and non-target lesions, or a partial response (PR), defined as at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, as assessed by the investigator and confirmed by radiographic imaging within four weeks of the initial observation. |
| Secondary | Percentage of Participants With Clinical Benefit (CB) | From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Clinical Benefit (CB) was defined as evidence of a complete response (CR), partial response (PR), or stable disease (SD). CR referred to the disappearance of all target and non-target lesions, PR to at least a 30% reduction in the sum of the longest diameters of target lesions from baseline, and SD to neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progression, based on the smallest sum of diameters recorded since treatment initiation. All assessments were made by the investigator. |
| Secondary | Time to Response (TTR) | From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Time to Response (TTR) was defined as the duration from randomization to the first documented evidence of either a complete response (CR) (the disappearance of all target and non-target lesions) or a partial response (PR) (at least a 30% reduction in the sum of the longest diameters of target lesions from baseline) as assessed by the investigator. |
| Secondary | Duration of Response (DOR) | From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Duration of Response (DOR) was defined as the time from the first documented evidence of a complete response (CR) or partial response (PR) until the first recorded sign of disease progression or death from any cause. According to RECIST, progression was defined as at least a 20% increase in the sum of diameters of target lesions from the smallest recorded sum or the appearance of one or more new lesions. Participants who had neither progressed nor died were censored at their follow-up visit, either because follow-up had ended or was ongoing. Those who received non-study anti-cancer therapies before progression were also censored. |
| Secondary | Percentage of Participants With Any On-therapy Adverse Event (AE) and Serious Adverse Event (SAE) | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its causal relationship. This included any unfavorable or unintended sign (such as abnormal lab findings), symptom, or disease, whether new or worsened. A Serious Adverse Event (SAE) was defined as any such occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or its prolongation, caused disability or incapacity, led to a congenital anomaly or birth defect, or was a potential case of drug-induced liver injury. |
| Secondary | Percentage of Participants With On-therapy Adverse Event (AE) by Maximum Grade | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant that was temporally associated with the use of a medicinal product, regardless of its relationship to the product. This included any unfavorable or unintended sign (such as abnormal lab results), symptom, or disease, whether new or worsened. The severity of AEs was graded according to NCI CTCAE version 3.0: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening), and Grade 5 (death related to toxicity). |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival at the Time of Primary Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | Primary Efficacy (PE) population | Months | MEDIAN |
| PRIMARY | Overall Survival in All Randomized Participants at the Time of Primary Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | Intent-to-Treat (ITT) Population | Months | MEDIAN |
| SECONDARY | Overall Survival at the Time of Final Analysis | From date of randomization till death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From date of randomization till the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Months | MEDIAN |
| SECONDARY | Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | From date of randomization till the date of the first documented response of CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinical Benefit (CB) | From date of randomization till date of disease progression (PD) or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Response (TTR) | From date of randomization till the first documented evidence of confirmed CR or PR, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants who had a confirmed CR or PR were analyzed for time to response. | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From the time of the first documented evidence of a confirmed CR or PR until the earliest date of disease progression or death due to any cause, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Primary Efficacy (PE) population. Only those participants who had a confirmed CR or PR were analyzed for duration of response. | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Any On-therapy Adverse Event (AE) and Serious Adverse Event (SAE) | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With On-therapy Adverse Event (AE) by Maximum Grade | From the first dose of study medication until 30 days after the last dose, assessed up the cut-off date for Final Analysis (03-Oct-2024) (average of 16 years) | Safety population. Only participants with On-therapy AEs | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group302
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival at the Time of Primary Analysis | CapeOx Plus Lapatinib | 12.2 | 95% Confidence Interval 10.6 to 14.2 | Months | |
| Overall Survival at the Time of Primary Analysis | CapeOx Plus Placebo | 10.5 | 95% Confidence Interval 9.0 to 11.3 | Months | |
| Overall Survival in All Randomized Participants at the Time of Primary Analysis | CapeOx Plus Lapatinib | 11.9 | 95% Confidence Interval 10.4 to 13.8 | Months | |
| Overall Survival in All Randomized Participants at the Time of Primary Analysis | CapeOx Plus Placebo | 10.4 | 95% Confidence Interval 9.1 to 11.3 | Months | |
| Overall Survival at the Time of Final Analysis | CapeOx Plus Lapatinib | 12.0 | 95% Confidence Interval 10.4 to 13.8 | Months | |
| Overall Survival at the Time of Final Analysis | CapeOx Plus Placebo | 10.4 | 95% Confidence Interval 9.0 to 11.3 | Months | |
| Progression Free Survival (PFS) | CapeOx Plus Lapatinib | 6.2 | 95% Confidence Interval 5.6 to 7.0 | Months | |
| Progression Free Survival (PFS) | CapeOx Plus Placebo | 5.4 | 95% Confidence Interval 4.4 to 5.7 | Months | |
| Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | CapeOx Plus Lapatinib | 131 | Participants | ||
| Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | CapeOx Plus Placebo | 94 | Participants |
1 to 10 of 302Source ClinicalTrials.gov
See all 302 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CapeOx Plus Lapatinib | 272 | |
| Overall Study | STARTED | CapeOx Plus Placebo | 273 | |
| Overall Study | Primary Efficacy (PE) Population | CapeOx Plus Lapatinib | 249 | |
| Overall Study | Primary Efficacy (PE) Population | CapeOx Plus Placebo | 238 | |
| Overall Study | Safety Population | CapeOx Plus Lapatinib | 270 | |
| Overall Study | Safety Population | CapeOx Plus Placebo | 267 | |
| Overall Study | Ongoing: On Study Treatment | CapeOx Plus Lapatinib | 1 | |
| Overall Study | Ongoing: On Study Treatment | CapeOx Plus Placebo | 0 | |
| Overall Study | Ongoing: In Follow Up | CapeOx Plus Lapatinib | 1 | |
| Overall Study | Ongoing: In Follow Up | CapeOx Plus Placebo | 0 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events504
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | CapeOx Plus Lapatinib | 16 | 270 | |
| other | Abdominal distension | Gastrointestinal disorders | CapeOx Plus Placebo | 9 | 267 | |
| other | Abdominal distension | Gastrointestinal disorders | CapeOx Plus Lapatinib (Long Term Follow-up (LTFU)) | 0 | ||
| other | Abdominal distension | Gastrointestinal disorders | CapeOx Plus Placebo (Long Term Follow-up (LTFU)) | 0 | ||
| other | Abdominal pain | Gastrointestinal disorders | CapeOx Plus Lapatinib | 27 | 270 | |
| other | Abdominal pain | Gastrointestinal disorders | CapeOx Plus Placebo | 32 | 267 | |
| other | Abdominal pain | Gastrointestinal disorders | CapeOx Plus Lapatinib (Long Term Follow-up (LTFU)) | 0 | ||
| other | Abdominal pain | Gastrointestinal disorders | CapeOx Plus Placebo (Long Term Follow-up (LTFU)) | 0 | ||
| other | Abdominal pain upper | Gastrointestinal disorders | CapeOx Plus Lapatinib | 20 | 270 | |
| other | Abdominal pain upper | Gastrointestinal disorders | CapeOx Plus Placebo | 27 | 267 |
1 to 10 of 504Source ClinicalTrials.gov
See all 504 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CapeOx Plus Lapatinib | 42 | 272 |
| Total, all-cause mortality | CapeOx Plus Placebo | 40 | 273 |
| Total, all-cause mortality | CapeOx Plus Lapatinib (Long Term Follow-up (LTFU)) | 199 | 230 |
| Total, all-cause mortality | CapeOx Plus Placebo (Long Term Follow-up (LTFU)) | 189 | 233 |
| Total, other adverse events | CapeOx Plus Lapatinib | 243 | 270 |
| Total, other adverse events | CapeOx Plus Placebo | 214 | 267 |
| Total, other adverse events | CapeOx Plus Lapatinib (Long Term Follow-up (LTFU)) | 0 | 0 |
| Total, other adverse events | CapeOx Plus Placebo (Long Term Follow-up (LTFU)) | 0 | 0 |
| Total, serious adverse events | CapeOx Plus Lapatinib | 73 | 270 |
| Total, serious adverse events | CapeOx Plus Placebo | 54 | 267 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CapeOx Plus Lapatinib vs CapeOx Plus Placebo: Percentage of Participants With Clinical Benefit (CB) | Trial comparisons |
| CapeOx Plus Lapatinib vs CapeOx Plus Placebo: Percentage of Participants With a Confirmed Complete Response (CR) or a Partial Response (PR) | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00680901
GET https://conductscience.org/api/trials/v1/NCT00680901/results?page=2