Trial · NCT00509002
Iressa Study in Patients With Salivary Gland Cancer
NCT00509002, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2017-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Iressa Study in Patients With Salivary Gland Cancer. Trials, record NCT00509002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00509002
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Iressa Study in Patients With Salivary Gland Cancer
- NCT number
- NCT00509002
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Salivary Gland Cancer
- Interventions
- Gefitinib
- First posted
- 2007-07-30
- Last updated
- 2017-11-24
- Results first posted
- 2017-11-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy | Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal | The modified Response Evaluation Criteria in Solid tumors (RECIST) criteria was used for objective tumor response assessment. Complete Response (CR): Disappearance all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): \>20% increase in sum LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or \> new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Response rate estimated by Gehan's Phase II clinical trial design. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy | Every 4 weeks until progressive disease, unacceptable toxicity or patient withdrawal | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy | Gefitinib | Complete Response | 0 | Participants | |
| Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy | Gefitinib | Partial Response | 0 | Participants | |
| Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy | Gefitinib | Stable Disease | 18 | Participants | |
| Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy | Gefitinib | Progressive Disease | 13 | Participants | |
| Response Rate of ZD1839 in Patients With Advanced or Recurrent Salivary Gland Cancer Who Are Not Candidate for Curative Surgery or Radiotherapy | Gefitinib | Inevaluable | 6 | 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 | Gefitinib | 37 | |
| Overall Study | COMPLETED | Gefitinib | 37 | |
| Overall Study | NOT COMPLETED | Gefitinib | 0 |
Source ClinicalTrials.gov
Adverse events5
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 | Anorexia | Gastrointestinal disorders | Gefitinib | 11 | 37 | 11 |
| other | Diarrhea | Gastrointestinal disorders | Gefitinib | 30 | 37 | 30 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Gefitinib | 7 | 37 | 8 |
| other | Fatigue | General disorders | Gefitinib | 15 | 37 | 16 |
| other | Rash/desquamation | Skin and subcutaneous tissue disorders | Gefitinib | 8 | 37 | 8 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gefitinib | ||
| Total, other adverse events | Gefitinib | 37 | 37 |
| Total, serious adverse events | Gefitinib | 0 | 37 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24585506 | DERIVED |
Source PubMed
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/NCT00509002
GET https://conductscience.org/api/trials/v1/NCT00509002/registered