Thyroid Cancer Stage IVPhase 1REPOTHYROID-IINCT07485569
Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial
A Phase 1 study testing Personalised treatment in people with Thyroid Cancer Stage IV and Anaplastic Thyroid Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
This is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer Stage IV, Anaplastic Thyroid Cancer, Differentiated Thyroid Cancer
- What is being tested?
- Personalised treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2026to 1 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Patients with locally advanced or metastatic TC (such as ATC, PDTC, and RAI refractory DTC progressive under treatment with multikinase inhibitors) for whom no approved conventional treatments are available.
- Prior anticancer treatment-related toxicities resolved to Grade ≤1 (CTCAE v5.0).
- Measurable disease per RECIST 1.1
- ECOG performance status ≤ 2
- Negative pregnancy test within 7 days prior to starting the study in women of childbearing potential and adequate use of contraception.
Who cannot join
- Inability to provide informed consent
- Inability to obtain a (new) biopsy for molecular profiling
- Pregnancy or breastfeeding.
- Other active malignancies requiring therapy.
- Neutropenia (ANC < 1.5 × 10⁹/L).
- Severe uncontrolled medical conditions (renal, cardiac, liver, respiratory).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Network Pharmacology-based Personalized Drug Repurposing in Thyroid Carcinoma: a Pilot Feasibility Trial
This is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.
Read the detailed description
Patients with advanced thyroid cancer often have very few treatment options, and standard therapies usually cannot cure the disease. Some types grow and spread quickly and do not respond to surgery and radioactive iodine. For patients with other types, existing drugs may slow the disease but can cause strong side effects, limiting their usefulness.
This study is testing a new personalized approach called network pharmacology-based drug repurposing. This concept uses genetic tumor information to identify combinations of existing approved drugs that may work better together. The idea is that targeting several connected networks in the tumor at the same time may be more effective than standard treatments that focus on a single target.
The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.
This is an exploratory, single-arm phase Ib trial. Each patient receives a personalized treatment based on the genetic profile of their tumor. The study focuses on understanding feasibility and safety. Each participant will be in the study for approximately 4 months. The first month is used to examine the tumor of the patient and select the best personalized treatment. Once the treatment is chosen and both the patient and their doctor agree, the patient will receive the treatment for three months. During treatment, patients will have regular check-ups, blood tests, scans, and questionnaires to monitor safety and see how well the treatment is controlling the tumor.
This study is funded by the EU horizon project Precision drug REPurpOsing For EUrope and the world (REPO4EU) under grant agreement No. 101057619
- Conditions
- Thyroid Cancer Stage IV, Anaplastic Thyroid Cancer, Differentiated Thyroid Cancer, Poorly Differentiated Thyroid Carcinoma
- Being tested
- Personalised treatment
- Keywords
- Drug repurposing, Thyroid cancer, Network pharmacology, Personalized therapy
- Medical subject headings
- Thyroid Neoplasms, Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised treatmentCombination product
The therapy will consist of (one or more) approved drugs.
| Study group | Role | What they receive |
|---|---|---|
| Personalized network-pharmacology-based combination therapy | Experimental | Patients with advanced thyroid cancer undergo tumor molecular profiling using to identify personalized drug repurposing treatments. All drugs are administered at authorized therapeutic doses according to the summary of product characteristics. Treatment regimens vary between patients depending on the identified molecular profile. Receives: Combination Product: Personalised treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Number and proportion of enrolled patients who initiate study treatment.
Measured: 12 weeks
Safety
Number and proportion of patients who experience treatment-related adverse events (CTCAE v5.0).
Measured: 12 weeks
Secondary outcomes (1)
Preliminary efficacy
Disease control rate (DCR) at 3 months, defined as the number and proportion of patients achieving stable disease (SD), partial response (PR), or complete response (CR), according to RECIST 1.1.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start1 Oct 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Thyroid Cancer Stage IVStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University, EU Horizon, Horizon Europe
- Responsible party
- Sponsor
- Investigators
- Romana Netea-Maier, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07485569
- Sponsor's protocol ID
- 2023-507214-28-00
- Other IDs
- 2023
- Acronym
- REPOTHYROID-II
- Status last verified
- Oct 2026
- First submitted
- 18 Jul 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nogales C, Mamdouh ZM, List M, Kiel C, Casas AI, Schmidt HHHW. Network pharmacology: curing causal mechanisms instead of treating symptoms. Trends Pharmacol Sci. 2022 Feb;43(2):136-150. doi: 10.1016/j.tips.2021.11.004. Epub 2021 Dec 9.
PubMed 34895945
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Pharmacology-based Personalized Drug Repurposing in Thyroid Carcinoma: a Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT07485569
- Acronym / sponsor ID
- REPOTHYROID-II / 2023-507214-28-00
- Conditions
- Thyroid Cancer Stage IV, Anaplastic Thyroid Cancer, Differentiated Thyroid Cancer, Poorly Differentiated Thyroid Carcinoma
- Keywords
- Drug repurposing, Thyroid cancer, Network pharmacology, Personalized therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University, EU Horizon, Horizon Europe
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 20 Mar 2026 (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 is a phase Ib trial that studies personalized network pharmacology-based drug repurposing in patients with advanced thyroid cancer who have no other treatment options. The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.
Detailed description
Patients with advanced thyroid cancer often have very few treatment options, and standard therapies usually cannot cure the disease. Some types grow and spread quickly and do not respond to surgery and radioactive iodine. For patients with other types, existing drugs may slow the disease but can cause strong side effects, limiting their usefulness.
This study is testing a new personalized approach called network pharmacology-based drug repurposing. This concept uses genetic tumor information to identify combinations of existing approved drugs that may work better together. The idea is that targeting several connected networks in the tumor at the same time may be more effective than standard treatments that focus on a single target.
The main objective is to study if it is feasible to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments are safe and can help control the growth of the patient tumors or stop them from getting worse.
This is an exploratory, single-arm phase Ib trial. Each patient receives a personalized treatment based on the genetic profile of their tumor. The study focuses on understanding feasibility and safety. Each participant will be in the study for approximately 4 months. The first month is used to examine the tumor of the patient and select the best personalized treatment. Once the treatment is chosen and both the patient and their doctor agree, the patient will receive the treatment for three months. During treatment, patients will have regular check-ups, blood tests, scans, and questionnaires to monitor safety and see how well the treatment is controlling the tumor.
This study is funded by the EU horizon project Precision drug REPurpOsing For EUrope and the world (REPO4EU) under grant agreement No. 101057619
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized network-pharmacology-based combination therapy | Experimental | Combination Product: Personalised treatmentPatients with advanced thyroid cancer undergo tumor molecular profiling using to identify personalized drug repurposing treatments. All drugs are administered at authorized therapeutic doses according to the summary of product characteristics. Treatment regimens vary between patients depending on the identified molecular profile. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with locally advanced or metastatic TC (such as ATC, PDTC, and RAI refractory DTC progressive under treatment with multikinase inhibitors) for whom no approved conventional treatments are available.
- Prior anticancer treatment-related toxicities resolved to Grade ≤1 (CTCAE v5.0).
- Measurable disease per RECIST 1.1
- ECOG performance status ≤ 2
- Negative pregnancy test within 7 days prior to starting the study in women of childbearing potential and adequate use of contraception.
Key exclusion criteria (6 listed)
- Inability to provide informed consent
- Inability to obtain a (new) biopsy for molecular profiling
- Pregnancy or breastfeeding.
- Other active malignancies requiring therapy.
- Neutropenia (ANC < 1.5 × 10⁹/L).
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 |
|---|---|---|
| Personalised treatmentThe therapy will consist of (one or more) approved drugs. | Combination product | Personalized network-pharmacology-based combination therapy |
Primary outcome
Feasibility
Time frame: 12 weeks
Number and proportion of enrolled patients who initiate study treatment.
Safety
Time frame: 12 weeks
Number and proportion of patients who experience treatment-related adverse events (CTCAE v5.0).
1 secondary outcome
Preliminary efficacy
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 34895945Nogales C, Mamdouh ZM, List M, Kiel C, Casas AI, Schmidt HHHW. Network pharmacology: curing causal mechanisms instead of treating symptoms. Trends Pharmacol Sci. 2022 Feb;43(2):136-150. doi: 10.1016/j.tips.2021.11.004. Epub 2021 Dec 9.
- REPO4EU consortium websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Thyroid Cancer Stage IV
Not yet recruitingPhase 2
Enfortumab Vedotin for the Treatment of Unresectable or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer, Medullary Thyroid Cancer, or NUT Carcinoma
Metastatic Differentiated Thyroid Gland Carcinoma, Metastatic NUT Carcinoma
Active, not recruitingPhase 2
Thermal Ablation and Spine Stereotactic Radiosurgery in Treating Patients With Spine Metastases at Risk for Compressing the Spinal Cord
Malignant Digestive System Neoplasm, Metastatic Head and Neck Carcinoma
RecruitingObservational study
Natural History of Medullary Thyroid Cancer to Inform Advanced Disease Management
Advanced Thyroid Gland Medullary Carcinoma, Stage III Thyroid Gland Medullary Carcinoma AJCC v8
Active, not recruiting
Cancer and Blood Pressure Management, CARISMA Study
Cardiovascular Disorder, Chronic Kidney Disease
Active, not recruitingPhase 2
Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer
Metastatic Thyroid Gland Carcinoma, Poorly Differentiated 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.
Romana Netea-Maier principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Personalised treatment in people with Thyroid Cancer Stage IV and Anaplastic Thyroid Cancer, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact R Netea-Maier, Prof. Dr. (+31243614599, romana.netea-maier@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 12 weeks). 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?
On the ClinicalTrials.gov record for NCT07485569, which also lists 1 linked publication.
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 28 Oct 2026.