A Study of AL2846 Capsule Versus Placebo in the Treatment of Advanced Radioiodine-Refractory Differentiated Thyroid Carcinoma

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT06860971
Phase
PHASE3
Status
Recruiting
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Conditions

  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AL2846 Capsules — DRUG
    AL2846 Capsule is a multi - target tyrosine kinase inhibitor, which has significant inhibitory effects on c-Mesenchymal-epithelial transition factor (c - MET), stem cell factor receptor (c - KIT), VEGFR1 and Ret Proto-Oncogene (RET).
  • AL2846 Placebo — DRUG
    AL2846 Placebo without drug substance.

Study Details

This study aims to demonstrate that, in subjects with locally advanced or metastatic iodine - refractory differentiated thyroid cancer who have failed previous VEGFR - targeted therapy, AL2846 can significantly prolong progression - free survival (PFS) compared with placebo.

Key Dates

First listed
Mar 6, 2025
Start date
Apr 18, 2025
Status verified
Dec 2024
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AL2846 Capsules
    The treatment cycle of AL2846 Capsules is 28 days.
  • Placebo Comparator: AL2846 Placebo
    The treatment cycle of AL2846 Placebo is 28 days.

Primary Outcome Measure

Progression - Free Survival (PFS) evaluated by the Independent Review Committee (IRC) [ Time Frame: 34 months ]

Central Contacts

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