XL092 for Thyroid Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Northwestern University

Must not be taking: Anticoagulants, CYP inhibitors, CYP inducers, others

Disqualifiers: Hepatitis B, Hepatitis C, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 months

33 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are taking certain anti-retroviral drugs or oral anticoagulants, you may need to change or stop them before starting the trial. It's best to discuss your specific medications with the trial team.

What safety data exists for XL092 (also known as XL-184) in humans?

XL-184, which is similar to XL092, has been tested in humans for various cancers, including thyroid cancer. In clinical trials, the side effects were generally mild to moderate, indicating it is relatively safe for human use. ^{1 2 3 4 5}

How does the drug XL092 differ from other treatments for thyroid cancer?

XL092 is unique because it is a pan-tyrosine kinase inhibitor, targeting multiple proteins like MET, VEGFR-2, and RET, which are involved in cancer growth. This broad targeting approach may offer advantages over treatments that focus on a single pathway. ^{1 6 7 8 9}

What is the purpose of this trial?

This phase II trial tests how well XL092 works for the treatment of patients with differentiated thyroid cancer that has not responded to previous treatment with radioiodine (radioiodine refractory) and that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). XL092 is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply, which may help keep cancer cells from growing.

Research Team

Jochen H Lorch

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for patients with differentiated thyroid cancer that hasn't responded to radioiodine treatment and has spread locally or elsewhere in the body. Participants should have a history of disease progression despite prior therapies.

Inclusion Criteria

My thyroid cancer is advanced, doesn't respond to iodine treatment, and has worsened in the last year.

Patients must have measurable disease according to RECIST v 1.1

ALP (alkaline phosphatase) ≤ 3 x Institutional ULN; For subjects with documented bone metastasis, ≤ 5 x ULN

Exclusion Criteria

I have not had significant blood in my urine, vomit, or coughed up blood in the last 3 months.

I have symptoms from lung cavities or airway disease.

I have hepatitis B.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive XL092 orally daily on days 1-21 of each cycle, with cycles repeating every 21 days in the absence of disease progression or unacceptable toxicity

12 months

Regular visits for imaging and sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days then every 3 months for 12 months

12 months

Follow-up visits every 3 months

Treatment Details

Interventions

• XL092

Trial Overview The study tests XL092, a tyrosine kinase inhibitor designed to block proteins that signal cancer cells to grow. It's given to see if it can stop the growth of thyroid cancer cells in patients with advanced stages of the disease.

Participant Groups

Group I: Treatment (XL092) Experimental Treatment 6 Interventions

Patients receive XL092 PO QD on days 1-21 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan or MRI and x-ray imaging, and blood and urine sample collection throughout the study.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. England pubmed.ncbi.nlm.nih.gov

XL-184, a MET, VEGFR-2 and RET kinase inhibitor for the treatment of thyroid cancer, glioblastoma multiforme and NSCLC. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Integration of a radiation biomarker into modeling of thyroid carcinogenesis and post-Chernobyl risk assessment. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

Changing trends of incidence and prognosis of thyroid carcinoma. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Transcriptomic signatures associated with autoimmune thyroiditis in papillary thyroid carcinoma and cancer immunotherapy-induced thyroid dysfunction. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pilot Study on the Impact of Polymorphisms Linked to Multi-Kinase Inhibitor Metabolism on Lenvatinib Side Effects in Patients with Advanced Thyroid Cancer. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[Treatment and prognosis of anaplastic thyroid carcinoma]. [2010]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical management of recurrent thyroid cancer. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A novel HSP90 modulator with selective activity against thyroid cancers in vitro. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Further evidence of the validity of risk group definition in differentiated thyroid carcinoma. [2004]