Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02622932
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Actual Duration (Months): 20
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors	Drug: Anlotinib and 14C-labeled Anlotinib	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
• Actual Study Start Date: Dec 2, 2015
• Actual Primary Completion Date: Dec 30, 2016
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anlotinib and 14C-labeled Anlotinib each participant will be given a single dose of 14C-labeled gilteritinib.	Drug: Anlotinib and 14C-labeled Anlotinib; oral

Outcome Measures

Primary Outcome Measures

1. Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine) [up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)]

2. Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces) [up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)]

3. Excretion rate of 14C-labeled Anlotinib (radioactivity in urine) [up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)]

4. Excretion rate of 14C-labeled Anlotinib (radioactivity in feces) [up to 10 Days (endpoint when the two consecutive time points of cumulative excretion <1%)]

5. 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,

6. 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.

7. Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood):Half life（t1/2） [up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)]

   Half life（t1/2）,t1/2 in h.

8. Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Area under the plasma concentration versus time curve (AUC) [up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)]

   Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.

9. Pharmacokinetics of 14C-labeled Anlotinib (Radioactivity in whole blood): Clearance（CL） [up to 10 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)]

   Clearance（CL）,CL in L/h.

Secondary Outcome Measures

1. Metabolite identification of Anlotinib in plasma, urine and feces [up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• signed and dated informed consent

• histologically or cytologically confirmed diagnosis of advanced solid tumor (including RCC、NSCLC、STS and CRC)

• failed to the treatment of line 1 or 2

• ECOG PS:0-1,Life expectancy of more than 3 months

• main organs function is normal

Exclusion Criteria:

• prior treatment with Anlotinib or Allergic to drug or its formulation ingredients

• subjects with the gastrointestinal tract, liver and kidney disease of affect drug absorption and metabolism

• CTCAE(4.0) Grade 1 or higher non-remission toxicity induced by any other previous treatments

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029

Sponsors and Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

• Study Director: Lihua Bao, Doctor, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02622932
• Other Study ID Numbers: ALTN-I-R
• First Posted: Dec 7, 2015
• Last Update Posted: Apr 30, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

No Results Posted as of Apr 30, 2019