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

Primary Purpose

Differentiated Thyroid Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Anlotinib
Placebo
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Beijing Tongren Hospital
  • Peking Union Medical College Hospital
  • Chongqing Cancer Hospital
  • Fujian Cancer Hospital
  • Gansu Province Tumor Hospital
  • Sun Yat-Sen University Cancer Center
  • Harbin medical university affiliated tumor hospital
  • Henan Province Tumor Hospital
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan Province Tumor Hospital
  • Jiangsu province tumor hospital
  • Jilin Cancer Hospital
  • Liaoning Province Tumor Hospital
  • Cancer Hospital of Fudan University
  • West China Hospital Of Sichuan University
  • 20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
  • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Anlotinib

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo.

Secondary Outcome Measures

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

Full Information

First Posted
October 22, 2015
Last Updated
May 20, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02586337
Brief Title
Study of Anlotinib in Patients With Differentiated Thyroid Cancer(ALTER01032)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anlotinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Anlotinib
Intervention Description
Anlotinib p.o. qd
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo p.o. qd
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo.
Time Frame
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 Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
To compare Overall Response Rate (ORR) (Complete and Partial Responses, CR and PR) of subjects treated with Anlotinib versus Placebo.
Time Frame
Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Chongqing Cancer Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
404100
Country
China
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
Country
China
Facility Name
Gansu Province Tumor Hospital
City
Lanzhou
State/Province
Gansu
Country
China
Facility Name
Sun Yat-Sen University Cancer Center
City
Guozhou
State/Province
Guangdong
Country
China
Facility Name
Harbin medical university affiliated tumor hospital
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Province Tumor Hospital
City
Luoyan
State/Province
Henan
Country
China
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Hunan Province Tumor Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu province tumor hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
Liaoning Province Tumor Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Cancer Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
West China Hospital Of Sichuan University
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400010
Country
China
Facility Name
20th Floor, Block C, Lake Road, Hexi District, Tianjin Medical University Cancer Institute and Hospital .
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300600
Country
China
Facility Name
The First Affiliated Hospital of Kunming Medical University
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China

12. IPD Sharing Statement

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

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