Clinical trial · Interventional
Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
A Phase 1, Open-label Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients
NCT02622932CI-TRIAL-00038380completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to Investigate the Absorption, Metabolism and Excretion of \[14C\] Anlotinib in Patients With Advanced Cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anlotinib and 14C-labeled Anlotinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anlotinib and 14C-labeled Anlotinib
- description
- each participant will be given a single dose of 14C-labeled gilteritinib.
- interventionNames
- Drug: Anlotinib and 14C-labeled Anlotinib
Primary outcomes (9)
- measure
- Cumulative excretion of 14C-labeled Anlotinib (radioactivity in urine)
- timeFrame
- up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
- measure
- Cumulative excretion of 14C-labeled Anlotinib (radioactivity in feces)
- timeFrame
- up to 10 Days(endpoint when the two consecutive time points of cumulative excretion <1%)
- measure
- Excretion rate of 14C-labeled Anlotinib (radioactivity in urine)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.