Drug Repurposing in Thyroid Carcinoma: a Feasibility Trial (REPOTHYROID-II)

April 10, 2026 updated by: Radboud University Medical Center

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 and safe to give patients individualized drug combinations selected based on their tumor genetic profile. The secondary objective is to find out whether these treatments can help control the growth of the patient tumors or stop them from getting worse.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 and safe to give patients individualized drug combinations selected based on their tumor genetic profile.

The secondary objective is to find out whether these treatments can help control the growth of the patient tumors or stop them from getting worse.

This is an exploratory, single-arm phase Ib umbrella 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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Personalized network-pharmacology-based combination therapy
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.
Combination product: Personalised treatment
The therapy will consist of (one or more) approved drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 12 weeks
Number and proportion of enrolled patients who initiate study treatment.
12 weeks
Safety
Time Frame: 12 weeks
Number and proportion of patients who experience treatment-related adverse events (CTCAE v5.0).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preliminary efficacy
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Maastricht University
Horizon Europe
EU Horizon

Investigators

  • Principal Investigator: Romana Netea-Maier, Radboud University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

July 18, 2023

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-507214-28-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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