Study of Anlotinib in Patients With Differentiated Thyroid Cancer(ALTER01032)

Differentiated Thyroid Cancer Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With 131I-Refractory Differentiated Thyroid Cancer(ALTER01032)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02586337
• Other study ID #: ALTN-01-IIDTC
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2015
• Est. completion date: December 2019

Study information

• Verified date: May 2019
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Differentiated Thyroid Cancer.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Signed and dated informed consent

2. Histological documentation of Differentiated Thyroid Cancer ,With measurable disease (using RECIST1.1)

3. ECOG PS:0-1,Life expectancy of more than 6 months

4. Subjects must be 131I-refractory / resistant as defined by at least one of the following:

• Lesions that do not demonstrate iodine uptake on any radioiodine scan

• Cumulative activity of 131I of >600 mCi or 22 gigabequerels (GBq)

• Lesion that demonstrate iodine uptake on any radioiodine scan,but has progressed by RECIST 1.1 within 18 months of 131I therapy

5. main organs function is normal

Exclusion Criteria:

1. Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)

2. Subjects received radiotherapy external exposure or 131I within 3 months prior to the first dose of study drug or plan to be received any anti-cancer treatment during study

3. Patients suffering from other malignancies currently or within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [ Ta (non-invasive carcinoma), Tis (carcinoma in situ) and T1 (carcinoma invasion into lamina propria) ]

4. CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments,excluding alopecia and Grade 2 or lower neurotoxicity induced by oxaliplatin

5. Patients with factors that could affect oral medication (such as dysphagia etc.)

6. Patients with pleural effusion or ascites, causing respiratory syndrome (CTCAE Grade 2 or higher dyspnea [Grade 2 dyspnea refers to Shortness of breath with a small amount of activities, affecting Instrumental activities of daily life])

7. Patients underwent major surgical treatment,open biopsy or significant traumatic injury within 28 days prior to assignment

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Anlotinib
Anlotinib p.o. qd
• Placebo
Placebo p.o. qd

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Province Tumor Hospital	Changsha	Hunan
China	Chongqing Cancer Hospital	Chongqing	Chongqing
China	West China Hospital Of Sichuan University	Chongqing	Sichuan
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Sun Yat-Sen University Cancer Center	Guozhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin medical university affiliated tumor hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Gansu Province Tumor Hospital	Lanzhou	Gansu
China	Henan Province Tumor Hospital	Luoyan	Henan
China	Jiangsu province tumor hospital	Nanjing	Jiangsu
China	Cancer Hospital of Fudan University	Shanghai	Shanghai
China	Liaoning Province Tumor Hospital	Shenyang	Liaoning
China	20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .	Tianjin	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo.	Date of randomization to the date of disease progression (measured every 6 weeks) or death (whichever occurs first) as determined by blinded independent imaging review(assessed up to 24 months)
Secondary	Overall Response Rate (ORR)	To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo.	Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months)