Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)

Phase 2

Completed

• Conditions: Medullary Thyroid Carcinoma
• Interventions: Drug: Placebo; Drug: Anlotinib

• Registration Number: NCT02586350
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-10-22
• Study First Submitted QC: 2015-10-22
• Study First Posted: 2015-10-26
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-19
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

1. Signed and dated informed consent
2. Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
3. ECOG PS:0-1,Life expectancy of more than 6 months
4. main organs function is normal

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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 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

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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 medullary thyroid carcinoma(MTC) 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)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Harbin medical university affiliated tumor hospital; 🇨🇳 Harbin, Heilongjiang, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Gansu Province Tumor Hospital; 🇨🇳 Lanzhou, Gansu, China

Sun Yat-Sen University Cancer Center; 🇨🇳 Guozhou, Guangdong, China

Henan Province Tumor Hospital; 🇨🇳 Zhengzhou, Henan, China

Hunan Province Tumor Hospital; 🇨🇳 Changsha, Hunan, China

Jiangsu province tumor hospital; 🇨🇳 Nanjing, Jiangsu, China

Cancer Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China

West China Hospital Of Sichuan University; 🇨🇳 Chongqing, Sichuan, China

20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .; 🇨🇳 Tianjin, Tianjin, China

The First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, Yunnan, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing, China

Jilin Cancer Hospital; 🇨🇳 Changchun, Jilin, China

Liaoning Province Tumor Hospital; 🇨🇳 Shenyang, Liaoning, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China