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A Phase 3 Study of Donafenib in Patients With Radioiodine-refractory Differentiated Thyroid Cancer

NCT03602495 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2021-12-13

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 study to compare the progression free survival, overall response rate (ORR) and safety of participants treated with Donafenib 0.3g Bid by continuous oral dosing versus placebo.

Conditions

  • Differentiated Thyroid Cancer

Interventions

DRUG

Donafenib

Donafenib 0.3g Bid orally, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.

DRUG

Placebo

Matching placebo Bid orally, continuously.

Sponsors & Collaborators

  • Suzhou Zelgen Biopharmaceuticals Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Lin Yan Song, MD · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-29
Primary Completion
2021-02-28
Completion
2021-07-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602495 on ClinicalTrials.gov