XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer

Part of paid clinical trials in Torrance, California.

Sponsor
Northwestern University
Study ID
NCT06959641
Phase
PHASE2
Status
Recruiting

Conditions

  • Locally Advanced Differentiated Thyroid Gland Carcinoma
  • Locally Advanced Poorly Differentiated Thyroid Gland Carcinoma
  • Locally Advanced Thyroid Gland Follicular Carcinoma
  • Locally Advanced Thyroid Gland Oncocytic Carcinoma
  • Locally Advanced Thyroid Gland Papillary Carcinoma
  • Metastatic Differentiated Thyroid Gland Carcinoma
  • Metastatic Poorly Differentiated Thyroid Gland Carcinoma
  • Metastatic Thyroid Gland Follicular Carcinoma
  • Metastatic Thyroid Gland Oncocytic Carcinoma
  • Metastatic Thyroid Gland Papillary Carcinoma
  • Refractory Differentiated Thyroid Gland Carcinoma
  • Refractory Poorly Differentiated Thyroid Gland Carcinoma
  • Refractory Thyroid Gland Follicular Carcinoma
  • Refractory Thyroid Gland Oncocytic Carcinoma
  • Refractory Thyroid Gland Papillary Carcinoma
  • Stage III Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage III Thyroid Gland Follicular Carcinoma AJCC v8
  • Stage III Thyroid Gland Papillary Carcinoma AJCC v8
  • Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8
  • Stage IV Thyroid Gland Follicular Carcinoma AJCC v8
  • Stage IV Thyroid Gland Papillary Carcinoma AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Survey Administration — OTHER
    Ancillary studies
  • X-Ray Imaging — PROCEDURE
    Undergo x-ray imaging
  • Zanzalintinib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 6, 2025
Status verified
May 2026
Primary completion
Sep 11, 2028
Completion
Sep 11, 2030

Study Design

Enrollment
33 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (XL092)
    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.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: From the time of the first dose of XL092 to the first documentation of disease progression, initiation of subsequent anti-cancer therapy, completion of 12 months of participation, or death from any cause, whichever occurs first, assessed at 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Harbor-UCLA Medical CenterTorranceCalifornia90502
Andrew Gianoukakis, MD
424-306-4000
Andrew Gianoukakis, MD (PRINCIPAL_INVESTIGATOR)
Northwestern UniversityChicagoIllinois60611
Jochen H. Lorch, MD
312-694-6959
Jochen H. Lorch (PRINCIPAL_INVESTIGATOR)

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