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)
Overview
- Phase
- Phase 2
- Intervention
- Anlotinib
- Conditions
- Differentiated Thyroid Cancer
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 113
- Locations
- 19
- Primary Endpoint
- Progression-free Survival (PFS)
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with Differentiated Thyroid Cancer.
Investigators
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
Arms & Interventions
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.
Intervention: Anlotinib
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
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)
To compare the Progression-free Survival (PFS) of subjects with Differentiated Thyroid Cancer(DTC) with Anlotinib versus Placebo.
Secondary Outcomes
- Overall Response Rate (ORR)(Date of randomization to the date of disease progression (measured every 6 weeks) or death (assessed up to 24 months))