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Compares treatment options for Thyroid Cancer
Official title Lenvatinib 24 mg/Day Versus 10 mg/Day to Treat Symptomatic or Progressive Radioactive Iodine Resistant (RAIR) Differentiated Thyroid Cancer (DTC)
ClinicalTrials.gov ID: NCT07092514
What this study is testing
What is Lenvatinib?
Lenvatinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for thyroid cancer.
Also referred to as Lenvima.
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 open-label, randomized phase II trial evaluates the dose delivery, tolerance, and efficacy of two dosing regimens of lenvatinib among patients with radioactive iodine resistant (RAIR) differentiated thyroid cancer (DTC).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- Histologically confirmed DTC, defined as papillary, follicular, or Hurthle Cell thyroid cancer. Papillary has several sub-types such as tall-cell and...
- Patient must have incurable RAIR DTC, defined as disease not amenable to cure by surgery AND meeting one or more of the following criteria:
- one or more sites of disease that do not take up RAI.
- disease progression on RAI (given within the last 12 months).
- receipt of cumulative dose of RAI of ≥ 600mCi.
You likely can't join if
- Anaplastic, poorly differentiated/high-grade, and medullary thyroid cancers.
- Prior treatment with lenvatinib.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or how well it works assessment of the...
- Currently receiving any other investigational agents.
- Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed...
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenvatinib or other agents used in the study.
See the full eligibility criteria
Who can join
- Histologically confirmed DTC, defined as papillary, follicular, or Hurthle Cell thyroid cancer. Papillary has several sub-types such as tall-cell and columnar cell, which are all allowed.
- Patient must have incurable RAIR DTC, defined as disease not amenable to cure by surgery AND meeting one or more of the following criteria:
- one or more sites of disease that do not take up RAI.
- disease progression on RAI (given within the last 12 months).
- receipt of cumulative dose of RAI of ≥ 600mCi.
- patient declines or is ineligible for surgery and/or RAI.
- Measurable or evaluable disease per RECIST 1.1.
- No more than 1 prior line of VEGF/VEGFR targeted therapy for DTC. Examples of VEGF/VEGFR therapies include sorafenib, pazopanib, vandetinib, axitinib, sunitinib, and cabozantinib, but others exist.
- Symptomatic (defined by usual standard of care clinical criteria) or progressive disease on most recent prior treatment (ex: surgery, RAI, or TKI/targeted therapy) by RECIST 1.1 over the last 16 months.
- At least 18 years of age.
- ECOG performance status ≤ 2.
- Screening blood pressure measurement \<140/90. Retesting is allowed.
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.0 K/cumm
- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (5.0 x IULN in the presence of hepatic metastases)
- Creatinine clearance \> 30 mL/min by Cockcroft-Gault
- UPC ≤ 1000 mg/G
- QTcF \< 481 msec
- The effects of lenvatinib on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study...
- Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.
What rules you out
- Anaplastic, poorly differentiated/high-grade, and medullary thyroid cancers.
- Prior treatment with lenvatinib.
- Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or how well it works assessment of the investigational regimen. Patients with prior or concurrent malignancy that does...
- Currently receiving any other investigational agents.
- Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
- A history of allergic reactions attributed to compounds of similar chemical or biologic composition to lenvatinib or other agents used in the study.
- Use of concurrent medications that have a high risk for QTc prolongation. A 7 day washout period of the high-risk medication is required prior to the first dose of Lenvatinib if a patient discontinues the high risk...
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or...
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative urine pregnancy test within 14 days of C1D1.
- HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at...
- Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing...
- History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are...
- Major surgery ≤ 14 days prior to C1D1; any surgical wound must be fully healed prior to C1D1. Inclusion Criteria for Crossover:
- Measurable or evaluable disease per RECIST 1.1.
- Symptomatic (defined by usual standard of care clinical criteria) or progressive disease by RECIST 1.1 while on lenvatinib.
- ECOG performance status ≤ 2.
- Re-screening blood pressure measurement \<140/90.
- Adequate bone marrow and organ function as defined below:
- Absolute neutrophil count ≥ 1.0 K/cumm
- Platelets ≥ 100 K/cumm
- Hemoglobin ≥ 9.0 g/dL
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN (5.0 x IULN in the presence of hepatic metastases)
- Creatinine clearance \> 30 mL/min by Cockcroft-Gault
- UPC ≤ 1000 mg/G
- QTcF \< 481 msec
- The most recent dose level of lenvatinib must be 10 mg/day. Exclusion Criteria for Crossover:
- Currently receiving any other investigational agents.
- Patients with untreated brain metastases. Patients with treated brain metastases (including those who had intracranial progression while on Lenvatinib) are allowed if post-treatment brain-imaging after CNS-directed...
- Use of concurrent medications that have a high risk for QTc prolongation.
- Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or...
- Experienced a grade three or higher treatment related adverse event requiring a dose delay on the 10 mg/day lenvatinib cohort
- Pregnant and/or breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- St Louis, Missouri, 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 St Louis, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.