Trial · NCT00095563
Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers
NCT00095563, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-04-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers. Trials, record NCT00095563. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095563
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers
- NCT number
- NCT00095563
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
High-grade Salivary Gland Carcinoma, High-grade Salivary Gland Mucoepidermoid Carcinoma, Low-grade Salivary Gland Carcinoma, Low-grade Salivary Gland Mucoepidermoid Carcinoma, Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Salivary Gland Acinic Cell Tumor, Salivary Gland Adenocarcinoma, Salivary Gland Adenoid Cystic Carcinoma, Salivary Gland Malignant Mixed Cell Type Tumor
- Interventions
- lapatinib ditosylate, laboratory biomarker analysis
- First posted
- 2004-11-08
- Last updated
- 2017-04-18
- Results first posted
- 2017-04-18
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rates (Partial and Complete Responses) | Up to 5 years | Per Response - Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; |
| Secondary | Duration of Objective Response | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | |
| Secondary | Rate of Stable Disease | 6 months | Number of patients who had Stable disease for more than or equal to 6 months together in both Adenoid cystic carcinoma (ACC) and non-adenoid cyctic carcinoma (non-ACC) |
| Secondary | Progression-free Survival (PFS) According to RECIST | From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years | |
| Secondary | Overall Survival (OS) | From the date of study enrolment to death or last contact, assessed up to 5 years | Survival estimates will be computed using the Kaplan-Meier method. |
| Secondary | Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading | Up to 5 years | Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rates (Partial and Complete Responses) | Up to 5 years | 36 assessable participants. | participants | NUMBER |
| SECONDARY | Duration of Objective Response | From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years | This assessment was not performed since no participants showed a response. | ||
| SECONDARY | Rate of Stable Disease | 6 months | 36 assessable participants, 19 with ACC and 17 with non-ACC. | participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) According to RECIST | From the date of study enrolment to disease progression, death or last contact, or last tumor assessment before the start of further anti-tumor therapy, assessed up to 5 years | 36 assessable participants, 19 with ACC and 17 with non-ACC. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of study enrolment to death or last contact, assessed up to 5 years | 20 participants with ACC, 19 participants with non-ACC. | months | MEDIAN |
| SECONDARY | Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading | Up to 5 years | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rates (Partial and Complete Responses) | Treatment (Lapatinib Ditosylate) | 0 | participants | ||
| Rate of Stable Disease | Treatment (Lapatinib Ditosylate) | ACC | 9 | participants | |
| Rate of Stable Disease | Treatment (Lapatinib Ditosylate) | Non-ACC | 4 | participants | |
| Progression-free Survival (PFS) According to RECIST | Treatment (Lapatinib Ditosylate) | ACC | 3.6 | 95% Confidence Interval 3.1 to 12.4 | months |
| Progression-free Survival (PFS) According to RECIST | Treatment (Lapatinib Ditosylate) | Non-ACC | 2.1 | 95% Confidence Interval 1.6 to 9.2 | months |
| Overall Survival (OS) | Treatment (Lapatinib Ditosylate) | ACC | NA | 95% Confidence Interval NA to NA | months |
| Overall Survival (OS) | Treatment (Lapatinib Ditosylate) | Non-ACC | 16.5 | 95% Confidence Interval 9.1 to 30.9 | months |
| Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading | Treatment (Lapatinib Ditosylate) | Diarrhea | 26 | participants | |
| Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading | Treatment (Lapatinib Ditosylate) | Fatigue | 28 | participants | |
| Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading | Treatment (Lapatinib Ditosylate) | Rash | 19 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Lapatinib Ditosylate) | 39 | |
| Overall Study | COMPLETED | Treatment (Lapatinib Ditosylate) | 39 | |
| Overall Study | NOT COMPLETED | Treatment (Lapatinib Ditosylate) | 0 |
Source ClinicalTrials.gov
Adverse events163
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 | Treatment (Lapatinib Ditosylate) | 2 | 39 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment (Lapatinib Ditosylate) | 4 | 39 | |
| other | Activated partial thromboplastin time prolonged | Investigations | Treatment (Lapatinib Ditosylate) | 4 | 39 | |
| other | Alanine aminotransferase increased | Investigations | Treatment (Lapatinib Ditosylate) | 8 | 39 | |
| other | Alkaline phosphatase increased | Investigations | Treatment (Lapatinib Ditosylate) | 12 | 39 | |
| other | Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Treatment (Lapatinib Ditosylate) | 5 | 39 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Treatment (Lapatinib Ditosylate) | 4 | 39 | |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Lapatinib Ditosylate) | 10 | 39 | |
| other | Anxiety | Psychiatric disorders | Treatment (Lapatinib Ditosylate) | 4 | 39 | |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Treatment (Lapatinib Ditosylate) | 1 | 39 |
1 to 10 of 163Source ClinicalTrials.gov
See all 163 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Lapatinib Ditosylate) | ||
| Total, other adverse events | Treatment (Lapatinib Ditosylate) | 39 | 39 |
| Total, serious adverse events | Treatment (Lapatinib Ditosylate) | 6 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00095563
GET https://conductscience.org/api/trials/v1/NCT00095563/events?page=2