Clinical trial · Interventional
Everolimus in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer
An Open Label Multi-Center Phase II Study of RAD001 in Advanced Thyroid Cancer
NCT01164176CI-TRIAL-00016203completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well everolimus works in treating patients with locally advanced or metastatic thyroid cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- RAD001 group
- interventionNames
- Drug: everolimus
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- every 3 month
Secondary outcomes (3)
- measure
- Overall survival
- timeFrame
- participants will be followed until death
- measure
- Progression-free survival
- timeFrame
- participants will be followed until disease progression or death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed thyroid cancer * Progressive or refractory disease within the past 6 months * Locally advanced or metastatic disease * Measurable disease, defined as ≥ 1 measurable lesion defined by RECIST criteria * Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy * No untreated brain metastasis PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 3 months * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Creatinine \< 1.5 mg/dL * Total bilirubin ≤ 1.0 times upper limit of normal (ULN) * ALT and AST ≤ 3.0 times ULN * No known hypersensitivity to the study drug * No serious uncontrolled systemic intercurrent illness (e.g., infection or poorly controlled diabetes) * No history of significant neurological or mental disorder, including seizures or dementia * No other malignancy within the past 5 years except for carcinoma in situ of the cervix or nonmelanomatous carcinoma of the skin * No active uncontrolled cardiac disease * No myocardial infarction within the past 12 months * Able to take oral medication * No active peptic ulcer disease * Must have patient compliance and geographic proximity for adequate follow-up PRIOR CONCURRENT THERAPY: * At least 30 days since prior mTor-inhibitor therapy (e.g., temsirolimus) or non-hormonal anticancer therapy * At least 2 weeks since prior and no concurrent P-glycoprotein, CYP3A4, and CYP3A5 inhibitors or inducers * No prior surgical procedure affecting absorption * No other concurrent systemic chemotherapy, investigational drug, or radiotherapy
References
Publications (1)
- DERIVEDLim SM, Chang H, Yoon MJ, Hong YK, Kim H, Chung WY, Park CS, Nam KH, Kang SW, Kim MK, Kim SB, Lee SH, Kim HG, Na II, Kim YS, Choi MY, Kim JG, Park KU, Yun HJ, Kim JH, Cho BC. A multicenter, phase II trial of everolimus in locally advanced or metastatic thyroid cancer of all histologic subtypes. Ann Oncol. 2013 Dec;24(12):3089-94. doi: 10.1093/annonc/mdt379. Epub 2013 Sep 19. PMID 24050953