Trial · NCT00559949

Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine

NCT00559949, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-01-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine. Trials, record NCT00559949. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00559949

On this page

Trial

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

Title: Selumetinib in Treating Patients With Papillary Thyroid Cancer That Did Not Respond to Radioactive Iodine
NCT number: NCT00559949
Status: Completed
Phases: Phase 2
Enrollment: 39 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Recurrent Thyroid Gland Carcinoma, Stage I Thyroid Gland Papillary Carcinoma, Stage II Thyroid Gland Papillary Carcinoma, Stage III Thyroid Gland Papillary Carcinoma, Stage IV Thyroid Gland Papillary Carcinoma
Interventions: Laboratory Biomarker Analysis, Selumetinib
First posted: 2007-11-19
Last updated: 2017-01-30
Results first posted: 2017-01-30
Limitations and caveats: Actuarial OS cannot be estimated due to long survival times in this disease.

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate (ORR)	Up to 2 years	ORR: Complete Response (CR) and Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). CR: Disappearance of all target lesions. PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. A conservative estimate of the response rate of the best-studied agent in this disease, doxorubicin, is approximately 5%. Therefore, investigators will assume that selumetinib (AZD6244, NSC 741078) would be worth further pursuit if the response rate (CR+PR) were at least 20%.
Secondary	Median Progression-Free Survival (PFS)	Up to 2 years	PFS is defined as the duration of time from start of treatment to time of progression or death. Progression evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST). Progressive Disease (PD): 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Secondary end points include toxicity, progression free survival, and overall survival. Due to the small sample size and absence of high quality historic data for this disease, these analyses were planned to be mostly exploratory and descriptive in nature.
Secondary	Occurrence of Treatment Related Adverse Events	Up to 2 years	Number of participants with related adverse events, per category and Grade category. Toxicity assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Secondary	Overall Survival (OS)	Up to 2 years	Overall Survival using the Kaplan-Meier method with associated confidence intervals. OS analysis was intended to be mostly exploratory and descriptive in nature.

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 Response Rate (ORR)	Up to 2 years	All evaluable participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Median Progression-Free Survival (PFS)	Up to 2 years	All participants	weeks	MEDIAN
SECONDARY	Occurrence of Treatment Related Adverse Events	Up to 2 years	All participants	adverse events	NUMBER
SECONDARY	Overall Survival (OS)	Up to 2 years	All participants	months	MEDIAN

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate (ORR)	All Evaluable Participants		1		Participants
Median Progression-Free Survival (PFS)	All Evaluable Participants		32	95% Confidence Interval 8.4 to 56	weeks
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Rash	23		adverse events
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Diarrhea	17		adverse events
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Fatigue	16		adverse events
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Peripheral edema	12		adverse events
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Elevated liver enzymes	9		adverse events
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Electrolyte abnormalities	7		adverse events
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Nausea/vomiting	7		adverse events
Occurrence of Treatment Related Adverse Events	All Evaluable Participants	Grade 1-2 - Stomatitis	6		adverse events

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I	39
Overall Study	COMPLETED	Arm I	32
Overall Study	NOT COMPLETED	Arm I	7

Source ClinicalTrials.gov

Adverse events71

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	Anemia	Blood and lymphatic system disorders	All Participants	10	39	21
other	Blurred vision	Eye disorders	All Participants	3	39	4
other	Extraocular muscle paresis	Eye disorders	All Participants	3	39	3
other	Eye disorders - Other, specify	Eye disorders	All Participants	2	39	2
other	Abdominal pain	Gastrointestinal disorders	All Participants	3	39	3
other	Constipation	Gastrointestinal disorders	All Participants	5	39	5
other	Diarrhea	Gastrointestinal disorders	All Participants	21	39	34
other	Dry mouth	Gastrointestinal disorders	All Participants	6	39	6
other	Dysphagia	Gastrointestinal disorders	All Participants	3	39	4
other	Flatulence	Gastrointestinal disorders	All Participants	3	39	3

1 to 10 of 71Source ClinicalTrials.gov

See all 71 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	All Participants
Total, other adverse events	All Participants	39	39
Total, serious adverse events	All Participants	7	39

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22241789	BACKGROUND

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
P30CA076292	Moffitt Cancer Center Support Grant	CLEVELAND, JOHN L.	H. LEE MOFFITT CANCER CTR & RES INST	NATIONAL CANCER INSTITUTE	1998 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/NCT00559949

GET https://conductscience.org/api/trials/v1/NCT00559949/results?page=2

API reference For AI assistants