Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and urine sample collection

  • Computed Tomography

    Procedure/Surgery

    Undergo CT scan

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Survey Administration

    Other intervention

    Ancillary studies

  • X-Ray Imaging

    Procedure/Surgery

    Undergo x-ray imaging

  • Zanzalintinib

    Drug

    Given PO

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Treatment (XL092)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

Progression is defined according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria. Median PFS at 12-months will be analyzed using the Kaplan-Meier method. The 12-month PFS estimate will be reported along with the confidence interval. Cox proportional hazards models will be applied to assess the impact of covariates such as age, sex, baseline disease severity, and genetic markers on PFS, when appropriate.

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

Secondary outcomes

1

Radiographic response rate

Defined as the proportion of patients who achieve a complete response or partial response as per RECIST v1.1. The point estimate of the objective response rate will be reported with its 2-sided 95% Clopper-Pearson exact confidence interval.

Time frame
Up to 12 month follow-up
2

Overall PFS

Will use the Kaplan-Meier method to estimate the overall PFS distribution. Subgroup comparisons will be made using log-rank tests, and a Cox proportional hazards model will be employed to assess covariate effects.

Time frame
From the first dose of XL092 to the date of the first progression event or death from any cause, assessed up to 12 month follow-up
3

Overall survival (OS)

OS will also be analyzed using the Kaplan-Meier estimator. Differences in survival distributions across patient subgroups will be evaluated using log-rank tests, and Cox models will be used to explore the effects of demographic and clinical variables on OS.

Time frame
From the start of treatment with XL092 to the date of death from any cause, assessed up to 12 month follow-up
4

Incidence of adverse events

Assessed by clinical review of all relevant parameters, including adverse events (AEs), concomitant medication queries, Eastern Cooperative Oncology Group performance status, weight and vital signs measurements, electrocardiogram measurements, and clinical laboratory testing values. The severity of AEs will be graded as mild, moderate, severe, or life-threatening according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All reported toxicities, regardless of attribution, by toxicity type and maximum grade will be summarized, and sorted by number of patients experiencing the toxicity. The maximum grade consolidates the reports of a given toxicity for a patient over time by taking the maximum across time. Categorical data analyses and summary statistics will be used to report AEs.

Time frame
Up to 30 days after the end of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jochen Lorch

Lead sponsor

Northwestern University

Sponsor institution

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now