Trial · NCT00073008
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tumor Response in the Targeted Population Through the End of Treatment | Baseline and then every 8 weeks through end of treatment | Disease progression and tumor response (number of participants achieving a complete response \[CR\] or partial response \[PR\]), using standardized criteria (Response evaluation criteria in solid tumors). CR, disappearance of all target lesions; PR, 30% decrease in the sum of the longest diameter of target lesions; progressive disease, 20% increase in the sum of the longest diameter of target lesions; stable disease, small changes that do not meet above criteria. Disease assessment was done at baseline and then every 8 weeks after starting treatment, until the participant discontinued treatment. |
| Secondary | Progression-free Survival (PFS) at Four Months in the Targeted Population | From randomization and then every 8 weeks up to four months | Percentage of participants in the Targeted Population, at 4 months after starting study drug, who were alive and without disease progression. |
| Secondary | Progression-free Survival (PFS) at Four Months in the Non-Targeted Population | From randomization and then every 8 weeks up to four months | Percentage of participants in the Non-Targeted Population, at 4 months after starting study drug, who were alive and without disease progression. |
| Secondary | The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue | From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples | To further characterize the participant population, these biomarkers could be tested: serum levels of ErbB1 and ErbB2; intra-tumoral expression of ErbB1, ErbB2, etc.; mutations in ErbB1, ErbB2, and k-ras. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, serum biomarkers were not analyzed. |
| Secondary | Pharmacokinetics (PK) of Lapatinib | From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug | To characterize the PK (absorption, distribution, metabolism, and excretion) of the study drug lapatinib in the participant population. PK is defined as the concentration of drug in a participant's blood at certain time points after the drug was taken by mouth. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacokinetics were not analyzed. |
| Secondary | Pharmacogenetics (PgX) | From randomization at every 4-week assessment through end of treatment | To (1) investigate the relationship between genetic variants in specific genes and the absorption, distribution, metabolism, and excretion (pharmacokinetics) of lapatinib, and to (2) investigate the relationship between genetic variants in select genes in DNA and the response (safety, efficacy, and tolerability) to lapatinib. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, pharmacogenetics were not analyzed. |
| Secondary | Quality of Life | Baseline and then every 4 weeks through end of treatment | Standard survey forms were completed by the participant at scheduled assessments to find out how the participant felt while on study. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, quality of life was not analyzed. |
| Secondary | Time to Response | From randomization and then every 8 weeks to time of response to study drug | Time from randomization until first documented evidence of partial or complete tumor response, measured using standard criteria (RECIST). Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to response was not analyzed. |
| Secondary | Duration of Response | Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death | For those participants who show a complete or partial response, duration of response would be time from first documented evidence of response (complete or partial response by RECIST) until disease progression or death, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, duration of response was not analyzed. |
| Secondary | Time to Tumor Progression | From randomization and then every 8 weeks to disease progression or death | Time from randomization until the first documented sign of disease progression or death due to any cause, if sooner. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, time to tumor progression was not analyzed. |
| Secondary | Overall Survival | From randomization and then every 8 weeks while on study drug and then every 3 months as follow-up until death | Overall survival is measured as the time from randomization until death due to any cause. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, overall survival was not analyzed. |
| Secondary | Review of Non-small Cell Lung Cancer (NSCLC) Histology (Cell Type) Using an Independent Review | Anytime from Baseline through end of study | Comparison of the specific cell type (histology) of non-small cell lung cancer from participant's tissue samples, as determined by local pathologist, to the type determined by an independent pathologist. Based on the interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment into the study was stopped due to lack of efficacy on both treatment arms; therefore, NSCLC histology was not analyzed. |
| Other | Tumor Response in the Non-Targeted Population Through the End of Treatment | Baseline and then every 8 weeks through end of treatment | Baseline and then every 8 weeks through end of treatment (end of treatment for each participant was dependent on when the participant withdrew from study therapy due to disease progression, an adverse event or participant decision) |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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