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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-02

Study Completion Date

2017-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anlotinib and 14C-labeled Anlotinib

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

Group Type EXPERIMENTAL

Anlotinib and 14C-labeled Anlotinib

Intervention Type DRUG

oral

Interventions

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Anlotinib and 14C-labeled Anlotinib

oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No