NCT02084732

Safety and Efficacy of Sorafenib in Patients With Advanced Thyroid Cancer: a Phase II Clinical Study

Completed Phase 2 Last updated 13 November 2019

What this trial tests

Phase 2 trial testing Sorafenib in Thyroid Cancer in 35 participants. Completed in 1 November 2019.

Timeline

1 October 2013

Primary endpoint
1 November 2019

1 November 2019

Quick facts

Lead sponsor	Instituto Nacional de Cancerologia, Columbia
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 October 2013
Primary completion	1 November 2019
Estimated completion	1 November 2019
Sites	1 location across Colombia

Drugs / interventions tested

• Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

• Thyroid Cancer — all drugs for Thyroid Cancer →

Sponsor

Instituto Nacional de Cancerologia, Columbia

Who can join

18 and older, any sex, with Thyroid Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Differentiated thyroid cancer includes papillary, follicular, Hurthle cell, and C-cell/medullary carcinoma. Even though incidence is relatively low (1% of all neoplasms), a rise in this disease has been recorded in the country (The Atlas of Cancer Mortality in Colombia, 2010).

Although this disease has a low rate of attributable mortality, the costs arising from treatment, monitoring, and disabilities among affected patients and their families are high for the health system.

The therapeutic approach to differentiated thyroid cancer once it starts progressing is limited; there are no truly favorable treatment options for patients with advanced thyroid cancer: available options include surgery, radiotherapy, and radioactive iodine therapy.

Molecular biology now allows the identification of the effects of mutations and alterations in the proteins that participate in cell signaling which account for dedifferentiation, invasiveness, and the progression of neoplastic cells.

VEGFR (vascular endothelial growth factor receptor) is one of the main molecules to be addressed by targeted molecular therapy. Its increased expression in differentiated thyroid cancer has been demonstrated and has been associated with increased growth, invasiveness, and shorter recurrence-free survival.

Different agents are effective against this tyrosine kinase receptor; nevertheless, taking into account that it is not solely responsible for tumor progression, according to clinical study results, it is more reasonable to use non-selective tyrosine kinase inhibitors such as sorafenib and motesanib. These inhibitors have already been tested in phase II studies.

Results from recent phase II research studies using these emerging treatment options have shown important effects in the therapeutic approach to other solid neoplasms.

Information about the safety of this type of treatment is limited; a need for information regarding the use of new therapeutic approaches in Colombia is one of the contributions that the National Institute of Cancer can make to the country through this study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Small molecules in targeted cancer therapy: advances, challenges, and future perspectives.
   Zhong L, Li Y, Xiong L, Wang W, et al · · 2021 · cited 1003× · PMID 34054126 · DOI 10.1038/s41392-021-00572-w
2. The Adverse Effect of Hypertension in the Treatment of Thyroid Cancer with Multi-Kinase Inhibitors.
   Ancker OV, Wehland M, Bauer J, Infanger M, et al · · 2017 · cited 48× · PMID 28335429 · DOI 10.3390/ijms18030625
3. Interplay of Ferroptosis and Cuproptosis in Cancer: Dissecting Metal-Driven Mechanisms for Therapeutic Potentials.
   Wang J, Li J, Liu J, Chan KY, et al · · 2024 · cited 33× · PMID 38339263 · DOI 10.3390/cancers16030512
4. Efficacy and safety of FLT3 inhibitors in monotherapy of hematological and solid malignancies: a systemic analysis of clinical trials.
   Zhao Y, Zhang X, Ding X, Wang Y, et al · · 2024 · cited 7× · PMID 38828446 · DOI 10.3389/fphar.2024.1294668
5. Tyrosine Kinase Inhibitors for Radioactive Iodine Refractory Differentiated Thyroid Cancer.
   Cortas C, Charalambous H. · · 2023 · cited 7× · PMID 38255638 · DOI 10.3390/life14010022
6. Safety and efficacy of sorafenib in patients with advanced thyroid carcinoma: a phase II study (NCT02084732).
   Fierro-Maya LF, González GG, Rojas Melo LJ, Cuéllar Cuéllar AA, et al · · 2021 · cited 4× · PMID 39421700 · DOI 10.20945/2359-3997000000373
7. Kinase-Inhibitors in Iodine-Refractory Differentiated Thyroid Cancer-Focus on Occurrence, Mechanisms, and Management of Treatment-Related Hypertension.
   Kaae AC, Kreissl MC, Krüger M, Infanger M, et al · · 2021 · cited 4× · PMID 34830100 · DOI 10.3390/ijms222212217
8. Leveraging molecular targeted drugs and immune checkpoint inhibitors treat advanced thyroid carcinoma to achieve thyroid carcinoma redifferentiation.
   Su JY, Huang T, Zhang JL, Lu JH, et al · · 2024 · cited 1× · PMID 38455407 · DOI 10.62347/ejaa3388