Surufatinib in Chinese Patients with Locally Advanced or Metastatic Differentiated Thyroid Cancer and Medullary Thyroid Cancer: A Multicenter, Open-Label, Phase II Trial

Thyroid ◽  
2020 ◽  
Vol 30 (9) ◽  
pp. 1245-1253 ◽  
Author(s):  
Jiaying Chen ◽  
Qinghai Ji ◽  
Chunmei Bai ◽  
Xiangqian Zheng ◽  
Yuan Zhang ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Phase Ii ◽  
Differentiated Thyroid Cancer ◽  
Medullary Thyroid Cancer ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Chinese Patients ◽  
Open Label ◽  
Medullary Thyroid ◽  
Open Label Phase

Vandetanib in metastatic hereditary medullary thyroid cancer: Follow-up results of an open-label phase II trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6018-6018 ◽  
Author(s):  
S. A. Wells ◽  
J. E. Gosnell ◽  
R. F. Gagel ◽  
J. F. Moley ◽  
D. G. Pfister ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Disease Control ◽  
Phase Ii ◽  
Tyrosine Kinases ◽  
Medullary Thyroid Cancer ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Disease Control Rate ◽  
Clinical Activity ◽  
Medullary Thyroid

6018 Background: Medullary thyroid cancer (MTC) is the most common cause of death in patients with hereditary syndromes caused by activating mutations in the RET protooncogene. RET activation is the initial oncogenic event, with the activity of other receptor tyrosine kinases, including VEGFR and EGFR, likely to contribute to tumor growth and metastasis. Vandetanib (ZD6474) is a once- daily oral agent that selectively targets RET, VEGFR and EGFR tyrosine kinases. Methods: Eligible patients had unresectable, measurable, locally advanced or metastatic hereditary MTC and a RET germline mutation. Patients received vandetanib 300 mg/day until disease progression or any other withdrawal criteria. The primary objective was to assess the objective tumor response (RECIST every 3 months). Secondary assessments included disease control rate, biochemical response (determined by decrements in plasma levels of calcitonin, a tumor marker for MTC) and safety and tolerability. Results: Thirty patients (21 female; median age 50 years) received initial treatment with vandetanib 300 mg. At data cut-off (20 Nov 2006), the median duration of treatment was 172 days. Based on site investigator assessments, 20% (6/30) of patients experienced a partial response (duration of response 59–260 days) and another 30% (9/30) of patients experienced stable disease =24 weeks, yielding a disease control rate of 50% (15/30). Centralized independent confirmation of response is planned. In 19 patients, plasma calcitonin levels showed a =50% decrease from baseline that was maintained for at least 6 weeks. Adverse events (AEs) occurring in >50% of patients were rash (73%), diarrhea (67%), fatigue (57%) and nausea (53%). Most AEs were grade 1 or 2; grade 3 AEs included asymptomatic QTc prolongation (n=5), rash and diarrhea (both n=3), all of which were manageable. Conclusions: Vandetanib has demonstrated clinical activity in this phase II study in metastatic hereditary MTC, and the safety profile is generally consistent with previous vandetanib monotherapy studies. Accrual is now complete (30 patients), and an updated analysis will be performed in April 2007. An international, randomized, placebo-controlled phase II trial of vandetanib in MTC is now recruiting patients. # No significant financial relationships to disclose.

Perioperative atezolizumab in combination with FLOT versus FLOT alone in patients with resectable esophagogastric adenocarcinoma: DANTE, a randomized, open-label phase II trial of the German Gastric Group of the AIO and the SAKK.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS4142-TPS4142
Author(s):  
Salah-Eddin Al-Batran ◽  
Claudia Pauligk ◽  
Ralf Hofheinz ◽  
Sylvie Lorenzen ◽  
Andreas Wicki ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Rank Test ◽  
R0 Resection ◽  
Open Label ◽  
Significance Level ◽  
Esophagogastric Cancer ◽  
Open Label Phase

TPS4142 Background: Perioperative FLOT chemotherapy has become a standard of care for locally advanced, resectable gastric cancer and adenocarcinoma of the GEJ. However, patient outcomes are still unsatisfactory and 5-year survival in T3-4 or nodal positive disease is still around 50%. Targeting the PD-1/PD-L1 pathway has proven active in different cancers, including esophagogastric cancer, and was associated with response rates in the 10-15% range in unselected, heavily pre-treated gastric cancer patients. Atezolizumab is a PD-L1 inhibitor with established efficacy and tolerability profiles. This study evaluates atezolizumab in the perioperative treatment of locally advanced, potentially resectable gastric or GEJ adenocarcinoma in combination with FLOT. Methods: This is a large, multinational, prospective, multicenter, randomized, investigator-initiated, open label phase II trial. Patients with locally advanced, potentially resectable adenocarcinoma of the stomach and GEJ (≥cT2 and/or N-positive) without distant metastases are enrolled. Eligibility status is centrally evaluated. Patients are randomized 1:1 to 4 pre-operative 2-week cycles (8 weeks) of FLOT (Docetaxel 50 mg/m²; Oxaliplatin 85 mg/m²; Leucovorin 200 mg/m²; 5-FU 2600 mg/m²) followed by surgery and 4 additional cycles of FLOT plus atezolizumab at 840 mg every 2 weeks, followed by a total of 8 additional cycles of atezolizumab at 1200 mg every 3 weeks as monotherapy (arm A) or FLOT alone (arm B). Primary endpoint is time to disease progression or relapse after surgery (PFS/DFS) as assessed by the Kaplan-Meier-Method. The statistical design is based on a target HR of 0.68, a power of 0.8, and a significance level of p< 0.05 (1-sided log rank test). A total of 295 patients will be randomized. Main secondary endpoints are rates of centrally assessed pathological regression (rates of complete and nearly complete pathological regression), overall survival, R0 resection, and safety. Recruitment started in Sept 2018; by February 2019, a total of 27 patients have been randomized. Clinical trial information: NCT03421288.

A phase II trial of doxorubicin and interferon alpha 2b in advanced, non-medullary thyroid cancer

2007 ◽  
Vol 26 (2) ◽  
pp. 183-188 ◽  
Author(s):  
Athanassios Argiris ◽  
Sanjiv S. Agarwala ◽  
Michalis V. Karamouzis ◽  
Lynn A. Burmeister ◽  
Sally E. Carty
Keyword(s):  
Thyroid Cancer ◽  
Interferon Alpha ◽  
Phase Ii ◽  
Medullary Thyroid Cancer ◽  
Phase Ii Trial ◽  
Medullary Thyroid ◽  
Interferon Alpha 2B

scholarly journals Vandetanib (ZD6474) in the Treatment of Medullary Thyroid Cancer

2011 ◽  
Vol 5 ◽  
pp. CMO.S6197 ◽  
Author(s):  
Hari Deshpande ◽  
Sanziana Roman ◽  
Jaykumar Thumar ◽  
Julie Ann Sosa
Keyword(s):  
Thyroid Cancer ◽  
Growth Factor ◽  
Phase Ii ◽  
Medullary Thyroid Cancer ◽  
Kinase Inhibitor ◽  
Locally Advanced ◽  
Growth Factor Receptor ◽  
Good Choice ◽  
Phase Ii Trials ◽  
Medullary Thyroid

Vandetanib (ZD6474) is an orally bioavailable small molecule tyrosine kinase inhibitor of multiple growth factor receptors, including RET (Rearrange during transfection), vascular endothelial growth factor receptor-2 (VEGFR-2) and epidermal growth factor receptor (EGFR). The activity against RET and VEGF made it a good choice in the treatment of medullary thyroid cancer (MTC). As there is considerable cross talk between growth factor pathways, dual inhibition with such agents has become an attractive strategy, in the treatment of many malignancies with encouraging Phase II clinical trial data to date. Vandetanib was tested in two Phase II trials in the treatment of patients with medullary thyroid cancer at doses of 100 mg and 300 mg daily respectively. The encouraging results of these 2 trials led to a randomized phase II trial comparing this medication to placebo using a crossover design. More than 300 patients were included in this study, which ultimately showed a significant improvement in progression-free survival in patients taking vandetanib. Based on these results, the Oncology Drug Advisory Committee (ODAC) of the Food and Drug Administration (FDA) recommended that vandetanib be approved for the treatment of patients with unresectable locally advanced or metastatic medullary thyroid cancer.

Phase II trial of sunitinib in medullary thyroid cancer (MTC).

2010 ◽  
Vol 28 (15_suppl) ◽  
pp. 5504-5504 ◽  
Author(s):  
J. A. De Souza ◽  
N. Busaidy ◽  
A. Zimrin ◽  
T. Y. Seiwert ◽  
V. M. Villaflor ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Phase Ii ◽  
Medullary Thyroid Cancer ◽  
Phase Ii Trial ◽  
Medullary Thyroid
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