Clinical trial for Locally Advanced Differentiated Thyroid Gland Carcinoma
Official title XL092 for the Treatment of Locally Advanced or Metastatic Radioiodine Refractory Differentiated Thyroid Cancer
ClinicalTrials.gov ID: NCT06959641
What this study is testing
What is Zanzalintinib?
Zanzalintinib is an investigational medicine, being studied as a potential treatment for locally advanced differentiated thyroid gland carcinoma.
Also referred to as Multi-kinase Inhibitor XL092, XL 092.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out whether XL092 can stop or slow the growth of these thyroid cancers.
- Who it's for
- Adults with differentiated thyroid cancer that is resistant to radioiodine and is locally advanced or metastatic.
- What's involved
- Participants will take XL092 tablets and attend regular clinic visits for safety checks, blood tests, and imaging scans to see how the tumor is responding.
- Time commitment
- The trial runs for several months, with clinic visits every few weeks for medication dispensing and monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 3.1.1 Patients must have a histologically confirmed locally advanced or metastatic, radioactive iodine (RAI) refractory, differentiated thyroid...
- 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).
- 3.1.5 Patients must have adequate organ and bone marrow function as defined: Leukocytes (WBC) ≥ 3,000/mcL, Absolute neutrophil count (ANC) ≥...
See the full eligibility criteria
- 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...
- 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).
- 3.1.5 Patients must have adequate organ and bone marrow function as defined: Leukocytes (WBC) ≥ 3,000/mcL, Absolute neutrophil count (ANC) ≥ 1,500/mcL (see footnote 2 regarding use of growth factors for neutropenia)...
- 3.1.6 For patients with a known history of Human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.
- 3.1.7 Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and patients are stable for at least 4 weeks...
- 3.1.8 Patients of child-bearing potential must have a negative pregnancy test prior to registration on study.
- 3.1.9 The effects of XL092 on the developing human fetus are unknown. For this reason and because tyrosine kinase inhibitors (TKIs) as well as other therapeutic agents used in this trial are known to be teratogenic...
- 3.1.10 Recovery to baseline or ≤ Grade 1 per NCI CTCAE v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Treating Investigator and/or stable on supportive therapy.
- 3.1.11 Patients must have the ability to understand and the willingness to sign a written informed consent document and comply with the protocol requirements.
- 3.2.1 Prior treatment with XL092 (zanzalintinib).
- 3.2.2 Patient has Hepatitis B.
- 3.2.3 Patient has Hepatitis C. NOTE: Patients with treated Hepatitis C and positive HCV antibody test are eligible only if followed by a negative HCV RNA test and no ongoing anti-HCV therapy.
- 3.2.4 Patient is pregnant or nursing (lactating) NOTE: Pregnant patients are excluded from this study because XL092 is a tyrosine kinase inhibitor with the potential for teratogenic or abortifacient effects.
- 3.2.5 Receipt of any type of small molecule kinase inhibitor treatment before the first dose of study treatment NOTE: See Section 4 for additional information on concomitant medications including restricted medications...
- 3.2.6 Receipt of any type of cytotoxic, biologic, or other systemic anticancer therapy (including investigational therapy or investigational device) before the first dose of study treatment.
- 3.2.7 Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks before the first dose of study treatment.
- 3.2.8 Previously identified allergy or hypersensitivity to components of the study treatment formulations, have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to...
- 3.2.9 Concomitant anticoagulation with oral anticoagulants (e.g., warfarin or other coumarinrelated agents, direct thrombin inhibitors, or anti-platelet agents such as clopidogrel, chronic use of aspirin above low dose...
- 3.2.10 Any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat cancer within 2 weeks before first dose of study treatment.
- 3.2.11 Patient has uncontrolled, significant intercurrent or recent illness
- 3.2.12 Other clinically significant disorders that would preclude safe study participation including having an uncontrolled intercurrent illness
- 3.2.13 Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 12 weeks before first dose of...
- 3.2.14 Symptomatic cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. NOTE: Asymptomatic or radiated endobronchial disease lesions allowed.
- 3.2.15 Lesions invading major blood vessel(s), including, but not limited to, inferior vena cava, pulmonary artery, or aorta.
- 3.2.16 Major surgery (see Appendix D) e.g., GI surgery, removal, or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment.
- 3.2.17 Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms within 14 days per electrocardiogram (ECG) before first dose of study treatment. NOTE: ECG evaluation is required at screening
- 3.2.18 History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent
- 3.2.19 Patients with: any other active malignancy within 2 years prior to start of study treatment a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or...
- 3.2.20 Administration of a live, attenuated vaccine (e.g., Intranasal influenza, measles, mumps, rubella, oral polio, Bacillus Calmette-Guérin, yellow fever, varicella, and TY21a typhoid vaccines) is prohibited: Within...
The study team makes the final eligibility decision.
Where it is enrolling
- Torrance, California, United States
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Torrance, California, United States; Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.