A Study To Test The Effect Of Apatinib On P450 Enzymes

• Status: Unknown status
• Trial end date: 2018-09-30
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Apatinib; Nifedipine; Warfarin

Criteria

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.