NCT00095563 · STUDY IN CONTEXT

Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers

Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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;

36 assessable participants.

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secondary · POSTED

Duration of Objective Response

This assessment was not performed since no participants showed a response.

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secondary · POSTED

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)

36 assessable participants, 19 with ACC and 17 with non-ACC.

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secondary · POSTED

Progression-free Survival (PFS) According to RECIST

36 assessable participants, 19 with ACC and 17 with non-ACC.

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secondary · POSTED

Survival estimates will be computed using the Kaplan-Meier method.

20 participants with ACC, 19 participants with non-ACC.

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secondary · POSTED

Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.

Source null

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-salivary-gland-cancer-recurrent-79ac7906
nct id: NCT00095563
trial label: Lapatinib in Treating Patients With Recurrent and/or Metastatic Adenoid Cystic Cancer or Other Salivary Gland Cancers
applicability: unclear
applicability note: Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0000
source section id
NCT00095563-om-0000
source outcome index
0
endpoint
Objective Response Rates (Partial and Complete Responses)
endpoint definition
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;
time origin
Up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
36 assessable participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0001
source section id
NCT00095563-om-0001
source outcome index
1
endpoint
Duration of Objective Response
endpoint definition
Duration of Objective Response
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
This assessment was not performed since no participants showed a response.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0002
source section id
NCT00095563-om-0002
source outcome index
2
endpoint
Rate of Stable Disease
endpoint definition
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)
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
36 assessable participants, 19 with ACC and 17 with non-ACC.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0003
source section id
NCT00095563-om-0003
source outcome index
3
endpoint
Progression-free Survival (PFS) According to RECIST
endpoint definition
Progression-free Survival (PFS) According to RECIST
time origin
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
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
36 assessable participants, 19 with ACC and 17 with non-ACC.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0004
source section id
NCT00095563-om-0004
source outcome index
4
endpoint
Overall Survival (OS)
endpoint definition
Survival estimates will be computed using the Kaplan-Meier method.
time origin
From the date of study enrolment to death or last contact, assessed up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
20 participants with ACC, 19 participants with non-ACC.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0005
source section id
NCT00095563-om-0005
source outcome index
5
endpoint
Most Frequent Adverse Events of Grade 1-2 by CTCAE Grading
endpoint definition
Number of participants that experienced the most frequent adverse events of grade 1-2 by CTCAE grading.
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0000
arm key
OG000
arm label
Treatment (Lapatinib Ditosylate)
regimen
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. lapatinib ditosylate: Given orally laboratory biomarker analysis: Correlative studies
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095563-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0001
arm key
OG000
arm label
Treatment (Lapatinib Ditosylate)
regimen
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. lapatinib ditosylate: Given orally laboratory biomarker analysis: Correlative studies
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095563-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0002
arm key
OG000
arm label
Treatment (Lapatinib Ditosylate)
regimen
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. lapatinib ditosylate: Given orally laboratory biomarker analysis: Correlative studies
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095563-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0003
arm key
OG000
arm label
Treatment (Lapatinib Ditosylate)
regimen
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. lapatinib ditosylate: Given orally laboratory biomarker analysis: Correlative studies
analyzed count
36
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095563-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0004
arm key
OG000
arm label
Treatment (Lapatinib Ditosylate)
regimen
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. lapatinib ditosylate: Given orally laboratory biomarker analysis: Correlative studies
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095563-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
outcome key
om-0005
arm key
OG000
arm label
Treatment (Lapatinib Ditosylate)
regimen
Patients receive oral lapatinib once daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. lapatinib ditosylate: Given orally laboratory biomarker analysis: Correlative studies
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00095563-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-salivary-gland-cancer-recurrent-79ac7906
nct id
NCT00095563
harm key
EG000
source section id
NCT00095563-ae
event group key
EG000
event group label
Treatment (Lapatinib Ditosylate)
serious affected
6
serious at risk
39
other affected
39
other at risk
39
frequency threshold
1
collection period
Source null
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice