Health Trials

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

ConditionsLocally Advanced Differentiated Thyroid Gland CarcinomaLocally Advanced Poorly Differentiated Thyroid Gland CarcinomaLocally Advanced Thyroid Gland Follicular CarcinomaLocally Advanced Thyroid Gland Oncocytic CarcinomaLocally Advanced Thyroid Gland Papillary CarcinomaMetastatic Differentiated Thyroid Gland CarcinomaMetastatic Poorly Differentiated Thyroid Gland CarcinomaMetastatic Thyroid Gland Follicular CarcinomaMetastatic Thyroid Gland Oncocytic CarcinomaMetastatic Thyroid Gland Papillary CarcinomaRefractory Differentiated Thyroid Gland CarcinomaRefractory Poorly Differentiated Thyroid Gland CarcinomaRefractory Thyroid Gland Follicular CarcinomaRefractory Thyroid Gland Oncocytic CarcinomaRefractory Thyroid Gland Papillary CarcinomaStage III Differentiated Thyroid Gland Carcinoma AJCC v8Stage III Thyroid Gland Follicular Carcinoma AJCC v8Stage III Thyroid Gland Papillary Carcinoma AJCC v8Stage IV Differentiated Thyroid Gland Carcinoma AJCC v8Stage IV Thyroid Gland Follicular Carcinoma AJCC v8Stage IV Thyroid Gland Papillary Carcinoma AJCC v8
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJochen Lorch

About 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.

Eligibility criteria

Qualifiers

3.1.1 Patients must have a histologically confirmed locally advanced or metastatic, radioactive iodine (RAI) refractory, differentiated thyroid cancer (including papillary, follicular, and oncocytic/Hurthle cell, and poorly differentiated thyroid cancer (PDTC)1 ), with progression within 12 months (per RECIST v1.1 response criteria) prior to study registration, and no prior therapy in the RAI-refractory setting and for which standard curative measures do not exist or are no longer effective. NOTE: availability of other standard TKI treatment options will not preclude patients from being eligible for this study. NOTE: RAI refractoriness is defined as absence of uptake of RAI on either a low-dose diagnostic test or a post-treatment RAI scan in measurable lesions or radiographic progression of disease within 12 months of the last course of RAI treatment despite the recorded uptake of RAI with that previous therapy or having a cumulative lifetime administered dose of ≥ 600mCi. Footnote 1: Poorly differentiated thyroid cancer (PDTC) is typically classified as a type of differentiated thyroid cancer (as opposed to undifferentiated thyroid cancer or anaplastic thyroid cancer)

3.1.2 Patients must have measurable disease according to RECIST v1.1 (see Appendix B and Section 2).

3.1.3 Patients must be age ≥ 18 years.

3.1.4 Patients must exhibit an ECOG Performance Score of ≤ 2 (see Appendix C for ECOG Performance Status Scale).

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Survey Administration
  • X-Ray Imaging
  • Zanzalintinib

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators

Jochen Lorch

Lead sponsor

Northwestern University

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov