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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02586350
Collaborator
(none)
91
Enrollment
19
Locations
2
Arms
39
Duration (Months)
4.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Jul 1, 2015
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Anlotinib
Other Names:
  • Anlotinib p.o. qd

    		•
    Placebo Comparator: 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.

    Drug: Placebo
    Placebo p.o. qd

    Outcome Measures

    Primary Outcome Measures

    1. 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

    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)]

      To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Signed and dated informed consent

    2. Histological documentation of medullary thyroid carcinoma(MTC),Unable to surgery(Stage

    1. or metastasis ,With measurable disease (using RECIST1.1)

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

    2. 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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cancer Institute and Hospital, Chinese Academy of Medical Sciences Beijing Beijing China 100021
    2 Beijing Tongren Hospital Beijing Beijing China
    3 Peking Union Medical College Hospital Beijing Beijing China
    4 Chongqing Cancer Hospital Chongqing Chongqing China 404100
    5 Fujian Cancer Hospital Fuzhou Fujian China
    6 Gansu Province Tumor Hospital Lanzhou Gansu China
    7 Sun Yat-Sen University Cancer Center Guozhou Guangdong China
    8 Harbin medical university affiliated tumor hospital Harbin Heilongjiang China
    9 Henan Province Tumor Hospital Zhengzhou Henan China
    10 Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei China 430022
    11 Hunan Province Tumor Hospital Changsha Hunan China
    12 Jiangsu province tumor hospital Nanjing Jiangsu China
    13 Jilin Cancer Hospital Changchun Jilin China 132000
    14 Liaoning Province Tumor Hospital Shenyang Liaoning China
    15 Cancer Hospital of Fudan University Shanghai Shanghai China
    16 West China Hospital Of Sichuan University Chongqing Sichuan China 400010
    17 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital . Tianjin Tianjin China 300600
    18 The First Affiliated Hospital of Kunming Medical University Kunming Yunnan China
    19 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022

    Sponsors and Collaborators

    • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT02586350
    Other Study ID Numbers:
    • ALTN-01-IIMTC
    First Posted:
    Oct 26, 2015
    Last Update Posted:
    May 21, 2019
    Last Verified:
    May 1, 2019
    Additional relevant MeSH terms:
    Carcinoma
    Thyroid Neoplasms
    Carcinoma, Neuroendocrine
    Thyroid Diseases

    Study Results

    No Results Posted as of May 21, 2019