Recurrent Thyroid Gland Carcinoma Clinical Trial
Official title:
Phase 2 Study of AZD6244 Hydrogen Sulfate in Iodine-131 Refractory Papillary Thyroid Carcinoma and Papillary Thyroid Carcinoma With Follicular Elements
This phase II trial is studying how well AZD6244 works in treating patients with papillary thyroid cancer that did not respond to radioactive iodine. AZD6244 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Ascertain the objective response rate (complete response and partial response) in
patients with iodine I 131-refractory papillary thyroid cancer treated with AZD6244.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this treatment in these patients. II. Determine the
pharmacokinetic profile of this treatment in these patients. III. Determine the
progression-free and overall survival of these patients. IV. Assess proxy measures of
treatment response (thyroglobulin and PET scan) in patients treated with AZD6244.
IV. Compare relevant laboratory correlates between responders and non-responders.
OUTLINE: This is a multicenter study.
Patients receive oral AZD6244 twice daily on days 1-28. Treatment repeats every 28 days in
the absence of unacceptable toxicity or disease progression.
Archived tissue is examined for gene mutations, including RET, BRAF, NTRK, and RAS, by
fluorescence in situ hybridization and/or polymerase chain reaction and fluorescence melting
curve analysis. Protein expression of ERK and phosphorylated ERK is assessed by
immunohistochemical staining.
Blood samples are collected periodically for pharmacokinetic analysis and biomarker
assessment (thyroglobulin and antithyroglobulin autoantibodies).
After completion of study therapy, patients are followed periodically for up to 2 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04284774 -
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
|
Phase 2 | |
| Completed |
NCT01709435 -
Cabozantinib S-Malate in Treating Younger Patients With Recurrent or Refractory Solid Tumors
|
Phase 1 | |
| Completed |
NCT01811212 -
Cabozantinib-S-Malate in Treating Patients With Refractory Thyroid Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT02393690 -
Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT01552434 -
Bevacizumab and Temsirolimus Alone or in Combination With Valproic Acid or Cetuximab in Treating Patients With Advanced or Metastatic Malignancy or Other Benign Disease
|
Phase 1 | |
| Active, not recruiting |
NCT01638533 -
Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction
|
Phase 1 | |
| Recruiting |
NCT04759911 -
Selpercatinib Before Surgery for the Treatment of RET-Altered Thyroid Cancer
|
Phase 2 | |
| Completed |
NCT00625846 -
Pazopanib Hydrochloride in Treating Patients With Advanced Thyroid Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT00381641 -
Sunitinib Malate in Treating Patients With Thyroid Cancer That Did Not Respond to Iodine I 131 and Cannot Be Removed by Surgery
|
Phase 2 | |
| Recruiting |
NCT05003856 -
Radiofrequency Ablation for the Treatment of Benign or Low Risk Thyroid Nodule
|
N/A | |
| Completed |
NCT00729157 -
Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
|
Phase 2 | |
| Active, not recruiting |
NCT02465060 -
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
|
Phase 2 | |
| Active, not recruiting |
NCT02152995 -
Trametinib in Increasing Tumoral Iodine Incorporation in Patients With Recurrent or Metastatic Thyroid Cancer
|
Phase 2 |