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

CTTQ

Status and phase: Completed; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Anlotinib and 14C-labeled Anlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02622932

ALTN-I-R

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Anlotinib and 14C-labeled Anlotinib

Experimental group

Description:

each participant will be given a single dose of 14C-labeled gilteritinib.

Treatment:

Drug: Anlotinib and 14C-labeled Anlotinib