Thyroid CancerPhase 2I-FIRSTNCT05182931
A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)
A Phase 2 study testing Dabrafenib 75 MG and Trametinib 2 MG in people with Thyroid Cancer, run by Olivia Newton-John Cancer Research Institute at 9 sites in Australia.
Trial summary
This prospective, multi-centre, open label, non-randomised phase II trial aims restore radioiodine sensitivity in patients with NRAS or BRAFV600E mutant refractory thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Dabrafenib 75 MG and Trametinib 2 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 9 sitesAustralia
- Study dates
- 14 Jul 2022to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed differentiated (including poorly differentiated) thyroid cancer that is either locally advanced or metastatic.
- Age > 18 years.
- Life expectancy > 12 weeks.
- Documented radiological progression by RECIST 1.1 in last 12 months.
- Radioiodine refractory (at least one of):
- one measurable lesion without radioiodine uptake on 131I scan,
Show all 22Show fewer
- at least one measurable lesion that had progressed by RECIST criteria within 12 months of 131I therapy despite 131I avidity at time of treatment, or
- cumulative treatment with >24 GBq (600 mCi) of 131I.
- At least one evaluable lesion as per RECIST v1.1 that has not been treated with local radiation therapy within 3 months prior to the first dose of TKI. Irradiated lesions can only be included as an evaluable lesion if it has shown radiological progression as per RECIST v1.1 on subsequent imaging following irradiation.
- NRAS or BRAF V600E mutation tested by NGS in a NATA accredited laboratory or by recognised sequencing platform.
- ECOG 0-1.
- Informed consent.
- Adequate haematological and biochemical parameters:
- Haemoglobin ≥ 9g/dL
- Neutrophils ≥ 1.5 x 109/L
- Platelets ≥ 100 x 109/L
- INR ≤ 1.4
- Serum Creatinine ≤ 1.3 x ULN
- Estimated Creatinine Clearance ≥ 30 ml/min (by Cockcroft Gault Formula)
- Serum ALT and AST ≤ 2.5 x ULN
- Serum Total Bilirubin ≤ 1.5 x ULN.
- TSH suppression <0.1mU/L or otherwise consistent with 2015 ATA Guidelines on Thyroid Cancer
Who cannot join
- Anaplastic thyroid cancer.
- Suitable for curative surgery or radiotherapy.
- Other anti-cancer (including TKI) therapy in prior 6 weeks.
- Concurrent malignancy other than non-melanoma skin cancer. Prior malignancies treated with curative intent and no evidence of recurrence in past three years may be allowed upon discussion with the medical monitor.
- Unstable brain metastasis. Treated or non-treated brain metastasis are allowed if neurologically stable, asymptomatic, on a stable steroid dose for a period of 2 weeks, and not anticipated to require any intervention during the trial treatment period. If treated with radiation or surgery, any related AE's should have recovered to ≤ grade 1 prior to enrolment on trial.
- Pregnancy, breastfeeding or unwilling to use contraception in those of child-bearing age.
Show all 9Show fewer
- Significant medical condition that would prevent compliance with study procedures.
- History of retinal vein occlusion or retinopathy.
- Iodine-containing contrast scan within 8 weeks of planned 124I scan.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Australia9 sites, 9 recruiting
- Recruiting
Royal Adelaide Hsopital
Adelaide, South Australia
Anne Taylor, MBBS
- Not yet recruiting
Eastern Health
Box Hill, Victoria, 3128
Chris Gillfilan, MBBS
Chris Gillfilan, MBBS
- Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
David Pattison, MBBS, FRACP
David Pattison, MBBS, FRACP
- Recruiting
Monash Health
Clayton, Victoria, 3168
Michael Mond, MBBS
Michael Mond, MBBS, FRACP
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
Andrew M Scott, MD, FRACP
Andrew M Scott, MBBS, FRACP
- Recruiting
Peter MacCallum Cancer Centre
Melbourne
Annette Lim, MBBS, FRACP
Annette Lim, MBBS, FRACP
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia
Roslyn Francis, MBBS, FRACP
Roslyn Francis, MBBS, FRACP
- Not yet recruiting
Alfred Hospital
Prahran, Victoria
Duncan Topliss, MBBS, FRACP
Duncan Topliss, MBBS, FRACP
- Recruiting
Royal North Shore Hospital
Sydney, New South Wales
Roderick Clifton-Bligh, MBBS, FRACP
Roderick Clifton-Bligh, MBBS
About this study
This prospective, multi-centre, open label, non-randomised phase II trial aims restore radioiodine sensitivity in patients with NRAS or BRAFV600E mutant refractory thyroid cancer.
Participants will be treated with Trametinib +/- Dabrafenib tyrosine kinase inhibitors for a period of 30 days, restoration of sensitivity will be monitored using 18F-FDG-PET \& I-124 PET imaging.
Read the detailed description
This is a prospective, non-randomised, multi-centre study which will be conducted at 10 sites around Australia.
Adult patients (18+ years) with radioiodine refractory differentiated thyroid cancer with BRAF V600E or NRAS mutant RECIST 1.1 evaluable tumours will be eligible to participate. .
All eligible patients will undergo a 18F-FDG PET/CT scan during the registration period (day -28), followed by T4 withdrawal and low iodine diet. T3 will be administered after T4 withdrawal and for up to 10 days prior to the 124I dose to minimise symptoms of hypothyroidism.
The first 124I dose will be administered orally at a dose of 40 MBq (1.08 mCi) on day -5 with a 18FDG-PET performed on the same day. Patients will then have 124I-PET imaging and bloods at 24 hrs (+/- 6 hrs) post-dose, with a second imaging time-point up until 120 hours post- 124I dose. The initial 124I study (pre-TKI) will serve as a baseline for the second 124I-PET (day 24, after 23 days of TKI), and demonstrate changes in NIS expression and radioiodine uptake as a result of TKI treatment.
Patients will then commence a total of 30 days of treatment with the MEK TKI trametinib (for NRAS mutant tumours) or the MEK and BRAF V600E TKI combination of trametinib and dabrafenib (for BRAF V600E mutant tumours). Patients will then have a further 18F-FDG PET/CT scan and 124I dose on day 23, and scans for dosimetry (124I-PET) at 24 hrs (+/- 6 hrs) post-dose (day 24), with a second imaging time-point up until 120 hours post-124I administration. If at least one lesion shows uptake on 124I scans consistent with > 20Gy / 6GBq (3.3Gy/GBq) 131I administered (based on the 24-hour scan), then 131I treatment will be administered on day 29. The dose of 131I administered will be fixed at 6 GBq (150 mCi) to allow for evaluation of dose response. TKI treatment will continue until the day after 131I treatment is given (total 30 days).
Follow-up staging (CT) will occur every 3 months for the first 24 months, then every 6 months until progression, and 18F-FDG PET at 6 and 12 months. Non-stimulated thyroglobulin (Tg) will also be measured at 3, 6, 9 and 12 months, and evaluated as a percentage change from baseline. QoL and health economic data will be collected in all patients going on study. Overall survival will be obtained by long-term follow-up. Central review of tumour mutations, 124I PET dosimetry, staging (RECIST) and 18F-FDG PET (PERCIST) will be performed.
- Conditions
- Thyroid Cancer
- Being tested
- Dabrafenib 75 MG, Trametinib 2 MG
- Keywords
- Radioiodine refractory, BRAF600E mutant, RAS mutant
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabrafenib 75 MGDrug
Also called Tafinlar
Refer arm description
Trametinib 2 MGDrug
Also called Mekinist
Refer arm description
| Study group | Role | What they receive |
|---|---|---|
| BRAFv600E mutant radioiodine refractory thyroid cancer | Experimental | Prior to commencing interventional treatment, participants will commence a low iodine diet and undergo thyroxine withdrawal and commence T3 replacement from day -27. On day -5 they will receive an oral dose of 124I (40MBq/1.08 mCi) with imaging at 24 hours (+/-6) post dose and a second imaging assessment within 120 hours.
Participants will receive Dabrafenib (oral, 150mg BD) and Trametinib (oral, 2mg OD) from day 1-30.
A second oral dose of I124 will be administered at day 24 followed by imaging at the same interval as baseline.
Participants achieving >20Gy tumour uptake of I124 will be administered 6GBq (3.3Gy/GBq) 131I, I131 wb scan and SPECT/CT will be performed within 24 hours and at hospital discharge.
Participants who do not achieve >20Gy tumour update of I-124 will move into follow up.
Follow up will occur every 12 weeks for 12 months. Receives: Drug: Dabrafenib 75 MG; Drug: Trametinib 2 MG |
| RAS mutant radioiodine refractory thyroid cancer | Experimental | Prior to commencing interventional treatment, participants will commence a low iodine diet and undergo thyroxine withdrawal and commence T3 replacement from day -27. On day -5 they will receive an oral dose of 124I (40MBq/1.08 mCi) with imaging at 24 hours (+/-6) post dose and a second imaging assessment within 120 hours.
Participants will receive Trametinib (oral, 2mg OD) from day 1-30.
A second oral dose of I124 will be administered at day 24 followed by imaging at the same interval as baseline.
Participants achieving >20Gy tumour uptake of I124 will be administered 6GBq (3.3Gy/GBq) 131I, I131 wb scan and SPECT/CT will be performed within 24 hours and at hospital discharge.
Participants who do not achieve >20Gy tumour update of I-124 will move into follow up.
Follow up will occur every 12 weeks for 12 months. Receives: Drug: Trametinib 2 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival as assessed by RECIST 1.1 criteria at 6 months in participants who proceed to I131 treatment
Radioiodine refractory thyroid cancer patients able to proceed to 131I treatment will be assessed by RECIST 1.1 criteria.
Measured: At 6 months following day 1.
Progression free survival as assessed by RECIST 1.1 criteria at 12 months in participants who proceed to I131 treatment
Radioiodine refractory thyroid cancer patients able to proceed to 131I treatment will be assessed by RECIST 1.1 criteria.
Measured: At 12 months following day 1.
Secondary outcomes (10)
Progression free survival as assessed by RECIST 1.1 criteria at 6 months in all participants and a control population (SELECT study)
To assess PFS by RECIST v1.1 at 6 in radioiodine-refractory thyroid cancer patients able to proceed to 131I treatment following TKI redifferentiation therapy,
- compared to those who do not proceed to 131I treatment.
- compared to a control population (from the SELECT study).
Measured: At 6 months following day 1.
Progression free survival as assessed by RECIST 1.1 criteria at 12 months in all participants and a control population (SELECT study)
To assess PFS by RECIST v1.1 at 12 months in radioiodine-refractory thyroid cancer patients able to proceed to 131I treatment following TKI redifferentiation therapy,
- compared to those who do not proceed to 131I treatment.
- compared to a control population (from the SELECT study).
Measured: At 12 months following day 1.
Objective response rate by RECIST 1.1 criteria in all treated participants
To assess objective response (CR/PR/SD) in all treated participants from time of enrolment until 18 months or PD.
Measured: 0-18 months or at PD
Overall survival of treated participants
To confirm the overall survival of participants receiving treatment on study via Kaplan-Meier estimation.
Measured: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Quantification of treatment related toxicities according to CTCAE V5.0
Quantification of treatment related toxicities according to CTCAE V5.0
Measured: From day -27 until 30 days following last dose [up to max 60 days].
Quantification of radioiodine uptake in metastatic lesions before and after TKI treatment.
Quantification of radioiodine uptake in metastatic lesions before and after TKI treatment.
Measured: From day -5 until day 30 on study.
Evaluation of response to treatment by percent change from baseline of non-stimulated thyroglobulin.
Evaluation of response to treatment by percent change from baseline of non-stimulated thyroglobulin.
Measured: Day 0; 3, 6, 9, 12 months in participants without radiological progression.
Evaluation and comparison of quality of life as measured by response to EORTC-QLQ-C30 in participants on study.
Evaluation of QOL in participants who proceed to I131 treatment compared with participants who proceed to follow up only by EORTC-QLQ-C30. Scores are from 0-100 with participant reported quality of live improving with a higher score.
Measured: Day -29, 1, 29; 3, 6, 9, 12 months.
Evaluation and comparison of QOL as measured by response to EQ-5D-5L in participants on study.
In participants who proceed to I131 treatment compared with follow up only by EQ-5D-5L. Five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems to extreme problems.
Measured: Day -29, 1, 29; 3, 6, 9, 12 months.
Evaluation and comparison of QOL as measured by response to Kessler Psychological Distress Scale (K10) in participants on study.
In participants who proceed to I131 treatment compared with follow up only by responses to the Kessler Psychological Distress Scale (K10). This is a 10-item questionnaire yielding a global measure of distress based on questions about anxiety and depressive symptoms. 5 levels ranging from none of the time to all of the time, higher level responses correspond with greater reported distress.
Measured: Day -29, 1, 29; 3, 6, 9, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start14 Jul 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with BRAF V600E mutant thyroid cancer will receive Dabrafenib + Trametinib; Participants with RAS mutant thyroid cancer will receive Trametinib alone.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivia Newton-John Cancer Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Royal North Shore Hospital, Austin Health, Sir Charles Gairdner Hospital, Monash Health, Peter MacCallum Cancer Centre, Australia, Royal Brisbane and Women's Hospital, Eastern Health, The Alfred, Royal Adelaide Hospital
- Responsible party
- Sponsor
- Investigators
- Andrew M Scott, MD, FRACP, Study chair, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05182931
- Sponsor's protocol ID
- ONJ2021-006
- Acronym
- I-FIRST
- Status last verified
- Oct 2023
- First submitted
- 23 Nov 2021
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Centre Trial of TKI Redifferentiation Therapy in Patients With RAIR Thyroid Cancer (I-FIRST Study)
- ClinicalTrials.gov ID
- NCT05182931
- Acronym / sponsor ID
- I-FIRST / ONJ2021-006
- Conditions
- Thyroid Cancer
- Keywords
- Radioiodine refractory, BRAF600E mutant, RAS mutant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Olivia Newton-John Cancer Research InstituteUniversity, hospital or other
- Collaborators
- Royal North Shore Hospital, Austin Health, Sir Charles Gairdner Hospital, Monash Health, Peter MacCallum Cancer Centre, Australia, Royal Brisbane and Women's Hospital, Eastern Health, The Alfred, Royal Adelaide Hospital
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective, multi-centre, open label, non-randomised phase II trial aims restore radioiodine sensitivity in patients with NRAS or BRAFV600E mutant refractory thyroid cancer.
Participants will be treated with Trametinib +/- Dabrafenib tyrosine kinase inhibitors for a period of 30 days, restoration of sensitivity will be monitored using 18F-FDG-PET \& I-124 PET imaging.
Detailed description
This is a prospective, non-randomised, multi-centre study which will be conducted at 10 sites around Australia.
Adult patients (18+ years) with radioiodine refractory differentiated thyroid cancer with BRAF V600E or NRAS mutant RECIST 1.1 evaluable tumours will be eligible to participate. .
All eligible patients will undergo a 18F-FDG PET/CT scan during the registration period (day -28), followed by T4 withdrawal and low iodine diet. T3 will be administered after T4 withdrawal and for up to 10 days prior to the 124I dose to minimise symptoms of hypothyroidism.
The first 124I dose will be administered orally at a dose of 40 MBq (1.08 mCi) on day -5 with a 18FDG-PET performed on the same day. Patients will then have 124I-PET imaging and bloods at 24 hrs (+/- 6 hrs) post-dose, with a second imaging time-point up until 120 hours post- 124I dose. The initial 124I study (pre-TKI) will serve as a baseline for the second 124I-PET (day 24, after 23 days of TKI), and demonstrate changes in NIS expression and radioiodine uptake as a result of TKI treatment.
Patients will then commence a total of 30 days of treatment with the MEK TKI trametinib (for NRAS mutant tumours) or the MEK and BRAF V600E TKI combination of trametinib and dabrafenib (for BRAF V600E mutant tumours). Patients will then have a further 18F-FDG PET/CT scan and 124I dose on day 23, and scans for dosimetry (124I-PET) at 24 hrs (+/- 6 hrs) post-dose (day 24), with a second imaging time-point up until 120 hours post-124I administration. If at least one lesion shows uptake on 124I scans consistent with > 20Gy / 6GBq (3.3Gy/GBq) 131I administered (based on the 24-hour scan), then 131I treatment will be administered on day 29. The dose of 131I administered will be fixed at 6 GBq (150 mCi) to allow for evaluation of dose response. TKI treatment will continue until the day after 131I treatment is given (total 30 days).
Follow-up staging (CT) will occur every 3 months for the first 24 months, then every 6 months until progression, and 18F-FDG PET at 6 and 12 months. Non-stimulated thyroglobulin (Tg) will also be measured at 3, 6, 9 and 12 months, and evaluated as a percentage change from baseline. QoL and health economic data will be collected in all patients going on study. Overall survival will be obtained by long-term follow-up. Central review of tumour mutations, 124I PET dosimetry, staging (RECIST) and 18F-FDG PET (PERCIST) will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with BRAF V600E mutant thyroid cancer will receive Dabrafenib + Trametinib; Participants with RAS mutant thyroid cancer will receive Trametinib alone.
| Arm | Type | Receives |
|---|---|---|
| BRAFv600E mutant radioiodine refractory thyroid cancer | Experimental | Drug: Dabrafenib 75 MG, Drug: Trametinib 2 MGPrior to commencing interventional treatment, participants will commence a low iodine diet and undergo thyroxine withdrawal and commence T3 replacement from day -27. On day -5 they will receive an oral dose of 124I (40MBq/1.08 mCi) with imaging at 24 hours (+/-6) post dose and a second imaging assessment within 120 hours. Participants will receive Dabrafenib (oral, 150mg BD) and Trametinib (oral, 2mg OD) from day 1-30. A second oral dose of I124 will be administered at day 24 followed by imaging at the same interval as baseline. Participants achieving >20Gy tumour uptake of I124 will be administered 6GBq (3.3Gy/GBq) 131I, I131 wb scan and SPECT/CT will be performed within 24 hours and at hospital discharge. Participants who do not achieve >20Gy tumour update of I-124 will move into follow up. Follow up will occur every 12 weeks for 12 months. |
| RAS mutant radioiodine refractory thyroid cancer | Experimental | Drug: Trametinib 2 MGPrior to commencing interventional treatment, participants will commence a low iodine diet and undergo thyroxine withdrawal and commence T3 replacement from day -27. On day -5 they will receive an oral dose of 124I (40MBq/1.08 mCi) with imaging at 24 hours (+/-6) post dose and a second imaging assessment within 120 hours. Participants will receive Trametinib (oral, 2mg OD) from day 1-30. A second oral dose of I124 will be administered at day 24 followed by imaging at the same interval as baseline. Participants achieving >20Gy tumour uptake of I124 will be administered 6GBq (3.3Gy/GBq) 131I, I131 wb scan and SPECT/CT will be performed within 24 hours and at hospital discharge. Participants who do not achieve >20Gy tumour update of I-124 will move into follow up. Follow up will occur every 12 weeks for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Histologically-confirmed differentiated (including poorly differentiated) thyroid cancer that is either locally advanced or metastatic.
- Age > 18 years.
- Life expectancy > 12 weeks.
- Documented radiological progression by RECIST 1.1 in last 12 months.
- Radioiodine refractory (at least one of):
Key exclusion criteria (9 listed)
- Anaplastic thyroid cancer.
- Suitable for curative surgery or radiotherapy.
- Other anti-cancer (including TKI) therapy in prior 6 weeks.
- Concurrent malignancy other than non-melanoma skin cancer. Prior malignancies treated with curative intent and no evidence of recurrence in past three years may be allowed upon discussion with the medical monitor.
- Unstable brain metastasis. Treated or non-treated brain metastasis are allowed if neurologically stable, asymptomatic, on a stable steroid dose for a period of 2 weeks, and not anticipated to require any intervention during the trial treatment period. If treated with radiation or surgery, any related AE's should have recovered to ≤ grade 1 prior to enrolment on trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dabrafenib 75 MGAlso: TafinlarRefer arm description | Drug | BRAFv600E mutant radioiodine refractory thyroid cancer |
| Trametinib 2 MGAlso: MekinistRefer arm description | Drug | BRAFv600E mutant radioiodine refractory thyroid cancer, RAS mutant radioiodine refractory thyroid cancer |
Primary outcome
Progression free survival as assessed by RECIST 1.1 criteria at 6 months in participants who proceed to I131 treatment
Time frame: At 6 months following day 1.
Radioiodine refractory thyroid cancer patients able to proceed to 131I treatment will be assessed by RECIST 1.1 criteria.
Progression free survival as assessed by RECIST 1.1 criteria at 12 months in participants who proceed to I131 treatment
Time frame: At 12 months following day 1.
Radioiodine refractory thyroid cancer patients able to proceed to 131I treatment will be assessed by RECIST 1.1 criteria.
10 secondary outcomes
Progression free survival as assessed by RECIST 1.1 criteria at 6 months in all participants and a control population (SELECT study)
Time frame: At 6 months following day 1.
Progression free survival as assessed by RECIST 1.1 criteria at 12 months in all participants and a control population (SELECT study)
Time frame: At 12 months following day 1.
Objective response rate by RECIST 1.1 criteria in all treated participants
Time frame: 0-18 months or at PD
Overall survival of treated participants
Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Quantification of treatment related toxicities according to CTCAE V5.0
Time frame: From day -27 until 30 days following last dose [up to max 60 days].
Quantification of radioiodine uptake in metastatic lesions before and after TKI treatment.
Time frame: From day -5 until day 30 on study.
Evaluation of response to treatment by percent change from baseline of non-stimulated thyroglobulin.
Time frame: Day 0; 3, 6, 9, 12 months in participants without radiological progression.
Evaluation and comparison of quality of life as measured by response to EORTC-QLQ-C30 in participants on study.
Time frame: Day -29, 1, 29; 3, 6, 9, 12 months.
Evaluation and comparison of QOL as measured by response to EQ-5D-5L in participants on study.
Time frame: Day -29, 1, 29; 3, 6, 9, 12 months.
Evaluation and comparison of QOL as measured by response to Kessler Psychological Distress Scale (K10) in participants on study.
Time frame: Day -29, 1, 29; 3, 6, 9, 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Thyroid Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Scott, MD, FRACP study chair
Austin Health
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dabrafenib 75 MG and Trametinib 2 MG in people with Thyroid Cancer, run by Olivia Newton-John Cancer Research Institute at 9 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kylie Wilkie (+61394963573, trials@onjcri.org.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival as assessed by RECIST 1.1 criteria at 6 months in participants who proceed to I131 treatment (time frame: At 6 months following day 1.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.