Trial · NCT00424255
Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery
NCT00424255, Phase 3, Completed, GlaxoSmithKline; results first posted 2014-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery. Trials, record NCT00424255. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00424255
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery
- NCT number
- NCT00424255
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 688 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Neoplasms, Head and Neck
- Interventions
- Lapatinib, Chemoradiation, Placebo
- First posted
- 2007-01-19
- Last updated
- 2014-07-18
- Results first posted
- 2014-02-11
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Free Survival (DFS) | From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks) | DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation. For participants whose disease did not recur or who did not die, DFS was censored at the time of the last independently assessed radiological scan (where initiation of alternative anti-cancer therapy had not commenced). Participants who missed two or more consecutive disease assessments were censored at the last assessment prior to the missed assessments. Participants considered to have malignant disease at Baseline were censored at the time of randomization. |
| Secondary | Overall Survival (OS) | From randomization until death due to any cause (average of 131 study weeks) | OS is defined as the time from randomization until death due to any cause. For participants who did not die, the time to death was censored at the time of last visit/contact. |
| Secondary | Disease Specific Survival (DSS) | From randomization until death due to head and neck cancer (average of 131 study weeks) | DSS is defined as the time from randomization until death due to head and neck cancer. Participants whose death was not related to the disease under study were treated as competing risks at the time death occured. Participants who were alive were censored at the time of their last visit. |
| Secondary | Time to Locoregional Recurrence (TTLR) | From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks) | TTLR is defined as the time from randomization until the first occurrence that local and/or regional recurrence is documented or the date of censor. Local relapse is defined as recurrent cancer in the primary tumor bed not clearly attributable to a second primary neoplasm. Regional relapse is defined as recurrent cancer in the neck not clearly attributable to a second primary neoplasm. All other events prior to locoregional recurrence were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data. |
| Secondary | Time to Distant Relapse (TTDR) | From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks) | TTDR is defined as the time from randomization until the first occurrence that distant relapse is documented. Distant relapse is defined as clear evidence of distant metastases (lung, bone, brain, etc.). Metastasis is defined as the spread of a cancer from one organ or part to another non-adjacent organ or part. All other events prior to a distant relapse were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data. |
| Secondary | Number of Participants With a Second Primary Tumor | From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks) | Participants who developed a second primary tumor at the time of the first recurrence or within 28 days of the first recurrence were measured. The criteria for a second primary tumor are as follows: a distinct lesion separated from the primary tumor site by \>2 centimeters of normal epithelium; or a new cancer with different histology; or any cancer, regardless of site, occurring \>=3 years after initial treatment. Participants with baseline disease were included in the denominator when calculating the percentage. |
| Secondary | Extent of Exposure | From randomization until end of 1year maintenance treatment (average of 63 study weeks) | Extent of exposure is defined as the duration of treatment administered during the study. The mean duration of treatment is calculated as the number of days between the start of treatment and the end of treatment inclusive (i.e., treatment stop date minus treatment start date + 1). Participants were counted in a treatment phase (monotherapy, chemoradiotherapy, and maintenance) if they had received any dose in that phase. Participants randomized to placebo who received \>=1 dose of lapatinib in error were included in the lapatinib arm. |
| Secondary | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of non-serious AEs occurring at a frequency threshold of 5% and SAEs. |
| Secondary | Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit | From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64) | Data are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI CTC version 3.0) toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated chemistry parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: albumin, alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transeferase (AST), total bilirubin (TB), calcium, carbon dioxide content/bicarbonate (CO2/HCO3), creatinine, glucose, potassium, and sodium. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. |
| Secondary | Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit | From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64) | Data are summarized using the NCI CTC version 3.0 toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated hematological parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. Hematology parameter included: hemoglobin, total neutrophils (TN), platelet count (PC), and White Blood Cell (WBC) count. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Free Survival (DFS) | From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks) | Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment, irrespective of whether they actually received study medication | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From randomization until death due to any cause (average of 131 study weeks) | ITT Population | Months | MEDIAN |
| SECONDARY | Disease Specific Survival (DSS) | From randomization until death due to head and neck cancer (average of 131 study weeks) | ITT Population | Months | MEDIAN |
| SECONDARY | Time to Locoregional Recurrence (TTLR) | From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks) | ITT Population | Months | MEDIAN |
| SECONDARY | Time to Distant Relapse (TTDR) | From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks) | ITT Population | Months | MEDIAN |
| SECONDARY | Number of Participants With a Second Primary Tumor | From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks) | ITT Population | Participants | NUMBER |
| SECONDARY | Extent of Exposure | From randomization until end of 1year maintenance treatment (average of 63 study weeks) | Safety Population (SP): all participants (par.) who were randomized and took \>=1 dose of study medication. Only par. available at the specified time points were analyzed (represented by n=X, X in the category titles). Different par. may have been analyzed for different parameters, so the overall number of par. analyzed reflects everyone in the SP. | Weeks | MEAN |
| SECONDARY | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) | From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks) | Safety Population | Participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit | From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64) | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population. | Participants | NUMBER |
| SECONDARY | Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit | From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64) | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different parameters, so the overall number of participants analyzed reflects everyone in the Safety Population. | Participants | NUMBER |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group538
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Free Survival (DFS) | Placebo | NA | 95% Confidence Interval 54.6 to NA | Months | |
| Disease Free Survival (DFS) | Lapatinib 1500 mg | 53.6 | 95% Confidence Interval 45.8 to NA | Months | |
| Overall Survival (OS) | Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Overall Survival (OS) | Lapatinib 1500 mg | NA | 95% Confidence Interval 58.8 to NA | Months | |
| Disease Specific Survival (DSS) | Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Disease Specific Survival (DSS) | Lapatinib 1500 mg | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Locoregional Recurrence (TTLR) | Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Locoregional Recurrence (TTLR) | Lapatinib 1500 mg | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Distant Relapse (TTDR) | Placebo | NA | 95% Confidence Interval NA to NA | Months | |
| Time to Distant Relapse (TTDR) | Lapatinib 1500 mg | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 538Source ClinicalTrials.gov
See all 538 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 342 | |
| Overall Study | STARTED | Lapatinib 1500 mg | 346 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Lapatinib 1500 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 342 | |
| Overall Study | NOT COMPLETED | Lapatinib 1500 mg | 346 |
Source ClinicalTrials.gov
Adverse events554
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 | Alanine aminotransferase increased | Investigations | Placebo | 31 | 336 | |
| other | Alanine aminotransferase increased | Investigations | Lapatinib 1500 mg | 30 | 349 | |
| other | Aspartate aminotransferase increased | Investigations | Placebo | 28 | 336 | |
| other | Aspartate aminotransferase increased | Investigations | Lapatinib 1500 mg | 33 | 349 | |
| other | Blood creatinine increased | Investigations | Placebo | 33 | 336 | |
| other | Blood creatinine increased | Investigations | Lapatinib 1500 mg | 44 | 349 | |
| other | Creatinine renal clearance decreased | Investigations | Placebo | 17 | 336 | |
| other | Creatinine renal clearance decreased | Investigations | Lapatinib 1500 mg | 27 | 349 | |
| other | Haemoglobin decreased | Investigations | Placebo | 29 | 336 | |
| other | Haemoglobin decreased | Investigations | Lapatinib 1500 mg | 33 | 349 |
1 to 10 of 554Source ClinicalTrials.gov
See all 554 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Lapatinib 1500 mg | ||
| Total, other adverse events | Placebo | 321 | 336 |
| Total, other adverse events | Lapatinib 1500 mg | 337 | 349 |
| Total, serious adverse events | Placebo | 133 | 336 |
| Total, serious adverse events | Lapatinib 1500 mg | 169 | 349 |
Source ClinicalTrials.gov
Papers3
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 |
|---|---|
| Lapatinib 1500 mg vs Placebo: Number of Participants With a Second Primary Tumor | Trial comparisons |
| Lapatinib 1500 mg vs Placebo: serious adverse events | 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/NCT00424255
GET https://conductscience.org/api/trials/v1/NCT00424255/registered?page=2