Comparison · NCT00680901-03e7f521
CapeOx Plus Lapatinib vs CapeOx Plus Placebo: Percentage of Participants With Clinical Benefit (CB)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. CapeOx Plus Lapatinib vs CapeOx Plus Placebo: Percentage of Participants With Clinical Benefit (CB). Trial comparisons, record NCT00680901-03e7f521. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00680901-03e7f521
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.799 | 0.745 | 0.844 | wilson | |
| Risk in group 2 | 0.79 | 0.734 | 0.837 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00928 | -0.0624 | 0.0813 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.01 | 0.924 | 1.11 | log | |
| Odds ratio, group 1 over group 2 | 1.06 | 0.682 | 1.64 | log | |
| Number needed to treat, for one more participant with the outcome on CapeOx Plus Lapatinib than on CapeOx Plus Placebo | 108 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CapeOx Plus Lapatinib | Participants received a combination therapy consisting of:~1. Oxaliplatin (Ox): 130 mg/m² intravenously on Day 1 of each 21-day cycle, for up to 8 cycles.~2. Capecitabine (Cape): 1700 mg/m² per day, taken orally in two divided doses from the evening of Day 1 to the morning of Day 15 (28 doses per cycle), followed by a minimum 6.5-day rest period. The dose could be increased to 2000 mg/m²/day after the first cycle at the investigator's discretion.~3. Lapatinib: 1250 mg orally once daily, starting on Day 1 and continued daily throughout the cycle, including the rest period.~After discontinuing oxaliplatin, capecitabine and lapatinib were continued until disease progression, unacceptable toxicity, or withdrawal of consent. | 199 | 249 | OG000 |
| Group 2 | CapeOx Plus Placebo | Participants received a combination therapy consisting of:~1. Oxaliplatin (Ox): 130 mg/m² intravenously on Day 1 of each 21-day cycle, for up to 8 cycles.~2. Capecitabine (Cape): 1700 mg/m² per day, taken orally in two divided doses from the evening of Day 1 to the morning of Day 15 (28 doses per cycle), followed by a minimum 6.5-day rest period. The dose could be increased to 2000 mg/m²/day after the first cycle at the investigator's discretion.~3. Lapatinib matching placebo: Taken orally once daily starting on Day 1 and continued throughout each cycle, including the rest period.~After discontinuing oxaliplatin, capecitabine and the lapatinib placebo were continued until disease progression, unacceptable toxicity, or withdrawal of consent. | 188 | 238 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Participants With Clinical Benefit (CB)
- Description
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.
- Time frame
- 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)
- Population
- Primary Efficacy (PE) population
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE3
- Conditions
- Neoplasms, Gastrointestinal Tract
- Interventions
- Lapatinib, Placebo, Capecitabine, Oxaliplatin
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2013-10-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00680901?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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