Trial · NCT00095836

Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy

NCT00095836, Phase 2, Completed, Massachusetts General Hospital; results first posted 2017-05-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy. Trials, record NCT00095836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00095836

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy
NCT number: NCT00095836
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Head and Neck Cancer
Interventions: Gefitinib
First posted: 2004-11-09
Last updated: 2017-05-31
Results first posted: 2017-05-31

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Objective Tumor Response Rate at 3, 6, and 12 Months	3 Months, 6 Months, 1 Year	Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
Secondary	Toxicity	Through study completion, on average 12 months	Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients
Secondary	Median Progression-free Survival	From the time of enrollment until disease progression or death, whichever came first	The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions.
Secondary	Overall Survival	5 years	The median overall survival time, measured from the time of enrollment until death.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Tumor Response Rate at 3, 6, and 12 Months	3 Months, 6 Months, 1 Year	Two patients lost to follow-up prior to assessment of tumor response	participants	NUMBER
SECONDARY	Toxicity	Through study completion, on average 12 months		participants	NUMBER
SECONDARY	Median Progression-free Survival	From the time of enrollment until disease progression or death, whichever came first		Months	MEDIAN
SECONDARY	Overall Survival	5 years		Months	MEDIAN

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Complete Response : 3 Months	0	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Partial Response : 3 Months	0	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Stable Disease : 3 Months	12	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Progressive Disease : 3 Months	13	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Complete Response : 6 Months	0	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Partial Response : 6 Months	0	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Stable Disease : 6 Months	6	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Progressive Disease : 6 Months	19	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Complete Response : 12 Months	0	participants
Objective Tumor Response Rate at 3, 6, and 12 Months	Gefitinib 250mg	Partial Response : 12 Months	0	participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gefitinib 250mg	27
Overall Study	COMPLETED	Gefitinib 250mg	23
Overall Study	NOT COMPLETED	Gefitinib 250mg	4

Source ClinicalTrials.gov

Adverse events43

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	Hemoglobin	Blood and lymphatic system disorders	Gefitinib 250mg	4	27	27
other	Hypotension	Vascular disorders	Gefitinib 250mg	4	27	66
other	Fatigue	General disorders	Gefitinib 250mg	11	27	49
other	Fever w/o neutropenia	General disorders	Gefitinib 250mg	2	27	5
other	Insomnia	General disorders	Gefitinib 250mg	2	27	8
other	Odor (patient odor)	General disorders	Gefitinib 250mg	4	27	22
other	Constitutional, other	General disorders	Gefitinib 250mg	2	27	6
other	Bruising	Skin and subcutaneous tissue disorders	Gefitinib 250mg	6	27	57
other	Induration/fibrosis	Skin and subcutaneous tissue disorders	Gefitinib 250mg	2	27	4
other	Photosensitivity	Skin and subcutaneous tissue disorders	Gefitinib 250mg	15	27	110

1 to 10 of 43Source ClinicalTrials.gov

See all 43 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gefitinib 250mg	2	27
Total, other adverse events	Gefitinib 250mg	27	27
Total, serious adverse events	Gefitinib 250mg	6	27

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
17985985	RESULT

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA006516	Dana-Farber/Harvard Cancer Center	EBERT, BENJAMIN LEVINE	DANA-FARBER CANCER INST	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00095836

GET https://conductscience.org/api/trials/v1/NCT00095836/results?page=2

API reference For AI assistants