Study of Anlotinib in Patients With Medullary Thyroid Carcinoma(ALTER01031)
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib Versus Placebo in Patients With Medullary Thyroid Carcinoma(ALTER01031)
1 other identifier
interventional
91
1 country
19
Brief Summary
To compare the effects and safety of Anlotinib with placebo in patients with Medullary Thyroid Carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2015
Typical duration for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 22, 2015
CompletedFirst Posted
Study publicly available on registry
October 26, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedMay 21, 2019
May 1, 2019
3.3 years
October 22, 2015
May 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
To compare the Progression-free Survival (PFS) of subjects with medullary thyroid carcinoma(MTC) 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 Outcomes (1)
Overall Response Rate (ORR)
Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months)
Study Arms (2)
Anlotinib
EXPERIMENTALAnlotinib 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.
Placebo
PLACEBO COMPARATORPlacebo 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.
Interventions
Eligibility Criteria
You may qualify if:
- Signed and dated informed consent
- Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage IV) or metastasis ,With measurable disease (using RECIST1.1)
- ECOG PS:0-1,Life expectancy of more than 6 months
- main organs function is normal
You may not qualify if:
- Prior treatment with Anlotinib or VEGFR-targeted therapies(such as Vandetanib,Cabozantinib,Lenvatinib,Sunitinib,Sorafenib etc.)
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 404100, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
Gansu Province Tumor Hospital
Lanzhou, Gansu, China
Sun Yat-Sen University Cancer Center
Guozhou, Guangdong, China
Harbin medical university affiliated tumor hospital
Harbin, Heilongjiang, China
Henan Province Tumor Hospital
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Province Tumor Hospital
Changsha, Hunan, China
Jiangsu province tumor hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, 132000, China
Liaoning Province Tumor Hospital
Shenyang, Liaoning, China
Cancer Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Hospital Of Sichuan University
Chongqing, Sichuan, 400010, China
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
Tianjin, Tianjin Municipality, 300600, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2015
First Posted
October 26, 2015
Study Start
July 1, 2015
Primary Completion
September 30, 2018
Study Completion
September 30, 2018
Last Updated
May 21, 2019
Record last verified: 2019-05