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

NCT02586337 | Unknown Phase 2

• 1 other identifier: ALTN-01-IIDTC
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

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

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Anlotinib DRUG

Anlotinib p.o. qd

Anlotinib

Placebo DRUG

Placebo p.o. qd

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (19)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 404100, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, China

Location

Gansu Province Tumor Hospital

Lanzhou, Gansu, China

Location

Sun Yat-Sen University Cancer Center

Guozhou, Guangdong, China

Location

Harbin medical university affiliated tumor hospital

Harbin, Heilongjiang, China

Location

Henan Province Tumor Hospital

Luoyan, Henan, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hunan Province Tumor Hospital

Changsha, Hunan, China

Location

Jiangsu province tumor hospital

Nanjing, Jiangsu, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

Liaoning Province Tumor Hospital

Shenyang, Liaoning, China

Location

Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

West China Hospital Of Sichuan University

Chongqing, Sichuan, 400010, China

Location

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

Tianjin, Tianjin Municipality, 300600, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

anlotinib

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: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

CN (19)