Clinical trial · Interventional
A Study To Test The Effect Of Apatinib On P450 Enzymes
A Single-center, Open-Label, Drug Interaction Study to Determine the Effects of Apatinib on the Metabolism of CYP3A4/5 and CYP2C9 Probe Drugs in Patients With Solid Tumors
- 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)
Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2（VEGFR-2）, inhibits multiple cytochrome P450 (CYP450) enzymes in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on CYP450 function by comparing the pharmacokinetics of CYP-specific probe drugs in the presence and absence of Apatinib. The probes used included Nifedipine (CYP3A specific), warfarin (CYP2C9 specific).
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 |
|---|---|---|---|
| Cytochrome P450 Interaction | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Nifedipine GTIS | Drug | — | UNRESOLVED |
| Warfarin Potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treament
- description
- In phase A, subjects receiving a single 30 mg oral dose of Nifedipine controlled-release tablets and wash-out for 2 days,a single 3 mg oral dose of warfarin tablets and wash-out for 12 days, then apatinib 750 mg once daily with a single 30 mg oral dose of Nifedipine controlled-release tablets co-administered on day 6 ,a a single 3 mg oral dose of warfarin tablets co-administered on day 9.
- interventionNames
- Drug: Apatinib
- Drug: Nifedipine GTIS
- Drug: Warfarin Potassium
Primary outcomes (1)
- measure
- Area under the plasma concentration versus time curve (AUC) of warfarin or nifedipine
- timeFrame
- 1 year
- description
- AUC0\~t of warfarin and nifedipine in the absence or in presence of apatinib will be defined
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced solid tumors. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow, renal, lung, and liver function. * A female subject must not be pregnant and will agree not to become pregnant during the trial Exclusion Criteria: * Primary carcinoma of liver * Any major surgery, chemotherapy, hormone therapy, investigational drugs, or radiotherapy within the last 28 days. * Poorly controlled hypertension. * A prior history of cardiovascular disease, arrhythmias, or significant ECG abnormalities, and corrected QT (QTc) prolongation defined as a QTc interval greater than or equal to 450 msec(male) or 470 msec(female). * Arterial or venous thrombi (including cerebrovascular accident). * Current use of therapeutic anticoagulation (low molecular weight heparin, oral anticoagulant agents). * Active brain metastases. * A history of bleeding problems.
References
Publications (0)
Data not yet available