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A Study To Test The Effect Of Apatinib On P450 Enzymes

Hengrui Medicine logo

Hengrui Medicine

Status and phase

Unknown
Phase 1

Conditions

Cytochrome P450 Interaction

Treatments

Drug: Warfarin Potassium
Drug: Apatinib
Drug: Nifedipine GTIS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03245307
HR-APTN-DDI-01

Details and patient eligibility

About

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).

Full description

This open-label study consists of a drug interaction phase that (part A) and a drug-continuation phase (part B). Patients will receive CYP450-probe drugs, and PK assessments will be performed before apatinib-administration and aſter once-daily administration of apatinib for 5 days (the predicted time point when steady-state plasma apatinib concentrations will have been achieved).

Enrollment

20 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Treament
Experimental group
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.
Treatment:
Drug: Nifedipine GTIS
Drug: Apatinib
Drug: Warfarin Potassium

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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