Condition category
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information



Primary contact

Mrs Sarah Flynn


Contact details

University of Leeds
Clinical Trials Research Unit (CTRU)
Woodhouse Lane
United Kingdom

Additional identifiers

EudraCT number

2015-002269-47 number

Protocol/serial number


Study information

Scientific title

SEL-I-METRY: Investigating the potential clinical benefit of Selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy



Study hypothesis

The aim of this study is to determine the proportion of patients for whom treatment with Selumetinib increases the amount of radioactive iodine taken up by the previously iodine-refractory thyroid cancers following a short course (4 weeks) of the drug.

Ethics approval

East Midlands – Leicester South Research Ethics Committee, 02/12/2015, ref: 15/EM/0455

Study design

Non-randomised study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Cancer; Subtopic: Head and Neck Cancer; Disease: Head and Neck


Participants will receive an initial I-123 SPECT/CT scan (under rhTSH stimulation) to determine baseline iodine uptake in thyroid cancer lesions. Participants will then receive Selumetinib in a tablet form, which they are to take home and administer according to the dosing schedule (150mg/day, therefore 6 x 25mg tablets, 3 twice per day).

Participants will then undergo another I-123 SPECT/CT after this 28-day period to determine if the iodine uptake in their thyroid cancer lesions has increased. If iodine uptake has increased sufficiently, participants will be referred for further I-131 therapy. Participants will be asked to continue taking Selumetinib from the time that they have the second I-123 scan to the time they receive their I-131. Participants who do not go on the receive I-131 therapy may stop Selumetinib treatment.

The total duration of the treatment will depend on the elapsed time between the second I-123 SPECT/ CT scan, the decision about I-131 therapy being made, and the I-131 therapy being received. The minimum duration of Selumetinib therapy is approximately 28 days. The maximum may be longer (up to 50 days).

Participants who do not go on to receive I-131 will have a single follow-up appointment 30 days after the final dose of Selumetinib. Participants who do go on to receive I-131 will be followed up three-monthly for one year, and then six-monthly until the end of the trial.

Intervention type



Not Applicable

Drug names


Primary outcome measures

Progression-free survival is determined at 12 months.

Secondary outcome measures

1. Safety is determined based on the occurrence of SAEs, SARs and SUSARs at 48 months
2. Toxicity is determined by the total number of adverse reactions, as graded by CTCAE V4.0, as identified in routine clinical assessments at each centre at 48 months
3. Radiological response rate for patients receiving radioiodine therapy is recorded at 48 months using ongoing CT scans (every 3 months for the first 6 months and then every 6 months thereafter)
4. Overall survival is determined from medical records at 48 months
5. Sufficient iodine uptake is assessed centrally using pre-defined criteria (an increase of 30% from baseline in participants who demonstrated baseline radioiodine uptake, or an increase of any level for participants who have no baseline radioiodine uptake) on an ongoing basis, with a report being collated at 48 months

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Diagnosed with locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, Hürthle cell, or poorly differentiated carcinoma) with at least one measurable lesion as measured by computed tomography (CT) or magnetic resonance imaging (MRI)
2. Participants must have iodine refractory disease, defined below:
2.1. One or more measurable lesions that do not demonstrate iodine uptake on a previous radioiodine scan (diagnostic uptake or post therapy)
2.2. One or more measurable lesions that have progressed by RECIST 1.1 criteria within 12 months of I131 therapy, despite demonstrable radioiodine avidity at the time of that treatment
3. Participants must have radiological progression by RECIST 1.1 criteria within the prior 12 months
4. Measurable disease by RECIST 1.1 criteria.
5. ECOG Performance Status = 1 and able to tolerate radioiodine therapy
6. Life expectancy of at least 12 weeks
7. Required laboratory values within 14 days of day 1 of treatment:
7.1. Adequate thyroidstimulating hormone (TSH) suppression < 0.5 mU/L
7.2. Creatinine clearance >50 ml/min,
7.3. Absolute Neutrophil Count =1.5x109/L (1500 per mm3)
7.4. Platelets =100x109/L (100,000 per mm3)
7.5. Haemoglobin >9.0 g/dL
7.6. Serum bilirubin =1.5 x upper limit of normal (ULN)
7.7. Patients with no liver metastasis must have AST or ALT = 2.5 x ULN
7.8. Patients with liver metastasis must have AST or ALT = 5 x ULN. If patients have AST or ALT > 3.5 x ULN and = 5 x ULN they must have an ALP= 6 x ULN
8. Patient’s with Gilbert’s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the
absence of evidence of haemolysis or hepatic pathology) will be eligible.
9. Able to give informed consent and willing to follow trial protocol.
10. Aged over 18
11. Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to starting therapy and agree to use dual methods of contraception for the duration of the trial and 6 months after completing treatment. Male participants must agree to use a barrier method of contraception for the duration of the trial and 4 months after completing treatment, if sexually active with a female of childbearing

Participant type


Age group




Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Foci of anaplastic thyroid cancer identified on histology
2. Able to receive curative surgery or radiation therapy
3. Major surgery with the exception of surgical placement for vascular access, open biopsy, or significant traumatic injury = 30 days prior to registration
4. Previous or concurrent cancer distinct in primary site or histology from thyroid cancer within previous 5 years, except for cervical cancer in situ, treated basal cell carcinoma, squamous cell carcinoma of the skin or superficial bladder tumour
5. Have received or are receiving an IMP or other systemic anticancer treatment within 4 weeks prior to the first dose of study treatment (6 weeks for nitrosoureas, mitomycin, and suramin), or within a period during which the IMP or anticancer treatment has not been cleared from the body (e.g. a period of 5 ‘halflives’), whichever is the most appropriate and as judged by the investigator
6. Any unresolved toxicity =CTCAE Grade 2 from previous anticancer therapy, except for alopecia
7. Prior exposure to Tyrosine Kinase, MEK, RAS or RAF inhibitors
8. Known or suspected allergy to Selumentinib or hypersensitivity to Selumetinib or any excipient agents or history of allergic reactions attributed to compounds of similar chemical or biologic composition to Selumetinib
9. Known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anticonvulsant medications for at least 4 weeks prior to the first dose of study medication
10. Requiring medication with high iodine content (e.g. amiodarone)
11. Participants who have had a iIodine contrast enhanced CT scan in previous 2 months

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Clinical Trials Research Unit (CTRU) Woodhouse Lane
United Kingdom

Sponsor information


Sheffield Teaching Hospitals NHS Trust

Sponsor details

Royal Hallamshire Hospital
Glossop Road
S10 2JF
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Cancer Research UK

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Funder name


Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype



United Kingdom

Results and Publications

Publication and dissemination plan

Intended publication of a study protocol and the study results upon completion of data analysis after the end of the trial.

Intention to publish date


Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

20/09/2016: Internal review. 01/08/2016: The recruitment start date has been updated from 01/06/2016 to 01/09/2016. 06/04/2016: The recruitment start date was changed from 18/01/2016 to 01/06/2016.