Select Ongoing Trials Currently Enrolling Patients with Thyroid Cancer

August 2016, Vol 6, No 8 - Clinical Trials Tracker


The following clinical trials represent a selection of key studies that are currently recruiting patients with thyroid cancer for inclusion in investigations of new therapies and new regimens of existing treatments for patients with thyroid cancer. Each clinical trial description includes the NLM Identifier to be used as a reference with ClinicalTrials.gov. The information below can help oncology practice managers and providers direct their eligible patients to one of these clinical trials.

1 Neoadjuvant Vemurafenib for Locally Advanced Thyroid Cancer

The purpose of this nonrandomized, open-label, parallel-assignment, phase 2 clinical trial is to assess how vemurafenib may affect certain biomarkers in patients with papillary thyroid cancer. Men and women aged ≥18 years with stage T3 or T4 papillary thyroid cancer with BRAF V600E mutation and an Eastern Cooperative Oncology Group (ECOG) status of ≤2 may be eligible for enrollment if other criteria are met. All eligible patients will receive vemurafenib before surgery. Patients will be divided into 3 treatment groups, in which group A will receive vemurafenib after surgery, group B will discontinue vemurafenib after surgery, and group C will undergo a computed tomography (CT) scan and core biopsy at day 56. The patients will take vemurafenib unless there is evidence of progressive disease on the day 56 CT scan. If scheduled for resection, patients will continue taking vemurafenib until surgery and will follow the same treatment schema as patients in groups A and B.

The primary outcome measure is the percentage change in extracellular-signal–regulated kinase phosphorylation and tumor size. The secondary outcome measure includes the objective response rate. This study plans to enroll 22 patients at the University of Texas M.D. Anderson Cancer Center in Houston. For more information, contact Madonna M. Pool, MSN, at 713-792-9851. The NLM Identifier is NCT01709292.

2 Dabrafenib plus Trametinib in Patients with BRAF V600E Mutation–Positive Thyroid Cancer

This phase 2, open-label, single-­group assignment assesses the efficacy and safety of dabrafenib in combination with trametinib in patients with BRAF V600E mutation–positive rare cancers, including thyroid cancer. Patients aged ≥18 years with an ECOG status of 0 to 2 and with a BRAF V600E mutation–positive tumor may be eligible for enrollment if other criteria are met. Eligible patients will receive dabrafenib plus trametinib.

The primary outcome measure is the overall response rate (ORR). The secondary outcome measures include the duration of response; investigator-assessed progression-free survival (PFS); overall survival (OS); the number of patients with adverse events; and the change from baseline in physical examination findings, vital signs, laboratory values, and cardiac assessments. This study expects to enroll 135 patients at multiple locations across the United States and abroad. For more information, contact US GlaxoSmithKline Clinical Trials Call Center at 877-379-3718 or GSKClinicalSupportHD@gsk.com. The NLM Identifier is NCT02034110.

3 Iodine I-131 with/without Selumetinib for Patients with Recurrent or Metastatic Thyroid Cancer

This phase 2, randomized, double-blind, parallel-assignment clinical trial assesses the efficacy of radioactive iodine (iodine I-131) with or without selumetinib in patients with thyroid cancer that has returned or has spread to other parts of the body. Men and women aged ≥18 years with recurrent and/or metastatic thyroid cancer and with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive selumetinib plus iodine I-131 or iodine I-131 plus placebo.

The primary outcome measure is the response rate at 6 months. The secondary outcome measures include the 6-month PFS, the best overall response, changes in serum thyroglobulin levels, and the incidence of adverse events. The other outcome measure is the genomic and transcriptomic landscape of radioactive iodine–avid tumors. This study expects to enroll 100 patients at multiple locations across the United States. For more information, contact Alan L. Ho at 507-266-0800 or hoa@mskcc.org. The NLM Identifier is NCT02393690.

4 Sorafenib with/without Everolimus for Advanced, Iodine I-131–Refractory Hürthle-Cell Thyroid Cancer

This phase 2, randomized, open-­label, crossover-assignment clinical trial will compare the efficacy and safety of sorafenib tosylate with or without everolimus in patients with advanced radioactive iodine (iodine I-131)-refractory thyroid cancer. Men and women aged ≥18 years with iodine I-131–refractory, histopathologically confirmed Hürthle-cell thyroid cancer, and with an ECOG performance status of ≤2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive sorafenib or sorafenib plus everolimus.

The primary outcome measure is PFS. The secondary outcome measures include confirmed response rate, OS, and the incidence of adverse events. This study plans to enroll 56 patients at multiple locations across the United States. For more information, contact Eric Sherman, MD, at 646-888-4234. The NLM Identifier is NCT02143726.

5 IMRT and Paclitaxel with/without Pazopanib for Anaplastic Thyroid Cancer

This randomized, double-blind, parallel-assignment, phase 2 clinical trial assesses the efficacy and safety of intensity-modulated radiation therapy (IMRT) and paclitaxel with or without pazopanib hydrochloride in patients with anaplastic thyroid cancer. Patients with a pathologically confirmed diagnosis of anaplastic thyroid cancer with a Zubrod performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive paclitaxel plus pazopanib hydrochloride and IMRT or paclitaxel plus placebo and IMRT.

The primary outcome measures include OS and the discontinuation of treatment because of toxicity. The secondary outcome measures include adverse events, local-regional control, and response of the primary site after chemoradiation. This study plans to enroll 121 patients at multiple locations across the United States. For more information, contact Eric J. Sherman at 212-639-7202 or shermane@mskcc.org. The NLM Identifier is NCT01236547.

6 Anlotinib Safety and Efficacy in Patients with Differentiated Thyroid Cancer

The purpose of this phase 2/3, randomized, double-blind, parallel-assignment clinical trial is to compare the efficacy and safety of anlotinib with that of placebo in patients with differentiated thyroid cancer. Patients aged 18 to 70 years may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive anlotinib or placebo.

The primary outcome measure is PFS, and the secondary outcome measure is ORR. This study plans to enroll 90 patients at multiple locations across China. For more information, contact Ming Gao at yunspider@126.com. The NLM Identifier is NCT02586350.

7 Pembrolizumab for Patients with Advanced Solid Tumors

This phase 2, open-label, single-group assignment clinical trial is evaluating the safety and efficacy of pembrolizumab in patients with multiple types of advanced solid tumors, including thyroid cancer, that have progressed during treatment with standard-of-care therapies. Women and men aged ≥18 years with histologically or cytologically confirmed tumor types, including thyroid cancer, and an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive pembrolizumab.

The primary outcome measure is objective response rate. This study plans to enroll 1100 patients at multiple locations across the United States and abroad. For more information, contact Merck at 888-577-8839. The NLM Identifier is NCT02628067.

8 GI-6207 for Advanced Medullary Thyroid Cancer

This randomized, open-label, parallel-assignment, phase 2 clinical trial evaluates the safety and efficacy of the heat-killed, recombinant, yeast-based vaccine GI-6207 for advanced medullary thyroid cancer. Men and women aged 18 to 100 years with histologically confirmed medullary thyroid cancer, with minimal or no disease-related symptoms, and with an ECOG performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will receive GI-6207 for 1 year or will undergo 6 months of surveillance followed by GI-6207 for 1 year.

The primary outcome measure is calcitonin growth rate kinetics after 6 months of therapy. The secondary outcome measures include time to progression and carcinoembryonic antigen–specific T-cells at 3 months compared with baseline. This study plans to enroll 37 patients at the National Institutes of Health Clinical Center in Bethesda, MD. For more information, contact Myrna Rauckhorst, RN, at 301-496-7224 or mr276f@nih.gov, or Ravi A. Madan, MD, at 301-496-3493 or rm480i@nih.gov. The NLM Identifier is NCT01856920.

9 Diagnosing Differentiated Thyroid Cancer Using a Blood Test

The purpose of this observational, case-control, prospective clinical trial is to investigate new ways of diagnosing thyroid cancer from blood samples using proteomic and genetic markers. Patients aged ≥18 years with thyroid cancer may be eligible for enrollment if other criteria are met. Eligible patients will have their blood samples assessed for thyroid cancer using proteomic and genetic markers.

The primary outcome measure is proteomic markers of differentiated thyroid cancer. The secondary outcome measure is genetic markers of differentiated thyroid cancer. This study expects to enroll 400 patients at the Sir Bobby Robson Cancer Research Unit in the United Kingdom. For more information, contact Petros Perros, BSc, MBBS, MD, at petros.perros@nuth.nhs.uk, or Lesley Naik at lesley.naik@nuth.nhs.uk. The NLM Identifier is NCT01586520.

10 MLN0128 for Young Patients with Metastatic Anaplastic Thyroid Cancer

This phase 2, open-label, single-group assignment clinical trial is assessing the efficacy of MLN0128 in patients with anaplastic thyroid cancer. Patients aged ≤18 years with histologically confirmed, newly diagnosed, or refractory/metastatic anaplastic thyroid cancer with an ECOG performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive MLN0128.

The primary outcome measure is PFS. The secondary outcome measures include ORR, OS, and the identification of biomarkers predictive of response to MLN0128 therapy. This study expects to enroll 25 patients at the Dana-Farber Cancer Institute in Boston. For more information, contact Jochen Lorch, MD, at 617-632-3090 or JLORCH@partners.org. The NLM Identifier is NCT02244463.

11 Nintedanib as Second-­Line Therapy for Thyroid Cancer

This phase 2, randomized, double-blind, parallel-assignment clinical trial is assessing the safety and efficacy of nintedanib as second-line therapy for patients with either differentiated or medullary thyroid cancer. Men and women aged ≥18 years with histologically confirmed differentiated or medullary thyroid cancer, with a life expectancy of more than 12 weeks, and with a World Health Organization (WHO) performance status of 0 or 1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive nintedanib or placebo.

The primary outcome measure is PFS. The secondary outcome measures include the occurrence of adverse events, the response rate, the duration of response, and exploration of the molecular mechanisms of action of nintedanib. This study plans to enroll 143 patients at multiple locations abroad. For more information, contact Aline Gheeraert, MSc, at aline.gheeraert@eortc.be. The NLM Identifier is NCT01788982.

12 Regorafenib as Second- or Third-Line Therapy for Metastatic Medullary Thyroid Cancer

This phase 2, open-label, single-­group assignment clinical trial is evaluating the efficacy of regorafenib as second- or third-line therapy in patients with metastatic medullary thyroid cancer. Patients aged ≥18 years with a histologically or cytologically confirmed diagnosis of metastatic medullary thyroid cancer, with a life expectancy of at least 12 weeks, and with an ECOG performance status of ≤1 may be eligible for enrollment if other criteria are met. Eligible patients will be randomized to receive regorafenib.

The primary outcome measures are response and PFS. The secondary outcome measures include safety variables, radiographic response, and biomarkers associated with response. This study expects to enroll 33 patients at the Dana-Farber Cancer Institute in Boston. For more information, contact Jochen Lorch, MD, at 617-632-3090 or JLORCH@partners.org. The NLM Identifier is NCT02657551.

13 Ceritinib for Mutation- and Oncogene-Directed Therapy in Patients with Thyroid Cancer

This phase 2, open-label, single-­group assignment clinical trial is designed to evaluate the activity of ceritinib in anaplastic or undifferentiated thyroid cancer. The protocol will evaluate anaplastic or undifferentiated thyroid cancer with mutations or rearrangements detected in the ALK gene. The primary focus of this portion of the protocol is identifying ceritinib’s activity in patients with anaplastic or undifferentiated thyroid cancer. Patients with mutations in ALK that are identified by sequencing their tumor samples or patients with established ALK abnormalities will receive the ALK inhibitor ceritinib. Patients aged ≥18 years with a histologically or cytologically confirmed diagnosis of anaplastic or undifferentiated thyroid cancer with mutations in the ALK gene and with a WHO performance status of 0 to 2 may be eligible for enrollment if other criteria are met. Eligible patients will receive ceritinib.

The primary outcome measure is disease progression. This study expects to enroll 10 patients at The University of Texas Southwestern Medical Center in Dallas. For more information, contact Pamela Kurian at 214-648-5874 or Pamela.Kurian@UTSouthwestern.edu. The NLM Identifier is NCT02289144.