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New treatment option 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, given as an once-daily infusion into a vein, 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
- 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.
- 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
- Inclusion:
- 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).
See the full eligibility criteria
Who can join
- Inclusion:
- 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. Please note...
- 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. NOTE: Patients of child-bearing potential are considered to be of child-bearing potential unless one of the...
- 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.
- 3.1.12 Patients must have the ability to swallow, retain and absorb oral medications. NOTE: Patients must have the ability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy...
- 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. The HCV RNA test will be...
- 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. Because...
- 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. NOTE: See Section 4 for...
- 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. Systemic treatment with radionuclides within 6 weeks before the first dose...
- 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. NOTE: people with intravascular tumor extension (e.g., tumor thrombus in renal vein or...
- 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. Prior laparoscopic surgeries (i.e., nephrectomy) within 4 weeks...
- 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; QT...
- 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's taking place
- 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 - 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?
Study sites include Torrance, California, United States; Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.