A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients

NCT02622932 Phase 1 COMPLETED

The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of \[14C\] Anlotinib in Patients With Advanced Cancer patients.

Details

Lead sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	6
Start date	2015-12-02
Completion	2017-08

Conditions

• Advanced Solid Tumors

Interventions

• Anlotinib and 14C-labeled Anlotinib

Primary outcomes

• Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine) — up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
• Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces) — up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
• Excretion rate of 14C-labeled Anlotinib (radioactivity in urine) — up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
• Excretion rate of 14C-labeled Anlotinib (radioactivity in feces) — up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%)
• Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak Plasma Concentration(Cmax) — up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
  Peak Plasma Concentration(Cmax),Cmax in ng/mL,
• Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Peak time（Tmax） — up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
  Peak time（Tmax）,Tmax in h.

Countries

China