Study of Anlotinib in Patients With Differentiated Thyroid Cancer(ALTER01032)
- Registration Number
- NCT02586337
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Differentiated Thyroid Cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 113
-
Signed and dated informed consent
-
Histological documentation of Differentiated Thyroid Cancer ,With measurable disease (using RECIST1.1)
-
ECOG PS:0-1,Life expectancy of more than 6 months
-
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
-
main organs function is normal
- Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
- 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
- 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) ]
- 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
- Patients with factors that could affect oral medication (such as dysphagia etc.)
- 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])
- Patients underwent major surgical treatment，open biopsy or significant traumatic injury within 28 days prior to assignment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. Anlotinib Anlotinib Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.Subjects with confirmation of disease progression by independent imaging review, while receiving blinded study drug may request to receive open label Anlotinib and enter the Optional Open Label Anlotinib Treatment Period of the Extension Phase. Subjects who request to receive open label Anlotinib(at the time of confirmed progression) will be informed whether they received placebo or Anlotinib during the period of blinded study drug administration. Subjects who received Anlotinib will not be eligible for the open-label phase.
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) 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) To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo.
- Secondary Outcome Measures
Name Time Method Overall Response Rate (ORR) Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months) To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo.
Trial Locations
- Locations (19)
Jiangsu province tumor hospital
🇨🇳Nanjing, Jiangsu, China
Beijing Tongren Hospital
🇨🇳Beijing, Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Gansu Province Tumor Hospital
🇨🇳Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
🇨🇳Guozhou, Guangdong, China
The First Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
Harbin medical university affiliated tumor hospital
🇨🇳Harbin, Heilongjiang, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Henan Province Tumor Hospital
🇨🇳Luoyan, Henan, China
Hunan Province Tumor Hospital
🇨🇳Changsha, Hunan, China
West China Hospital Of Sichuan University
🇨🇳Chongqing, Sichuan, China
Cancer Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Liaoning Province Tumor Hospital
🇨🇳Shenyang, Liaoning, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China