Status:
UNKNOWN
A Study To Test The Effect Of Apatinib On P450 Enzymes
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Cytochrome P450 Interaction
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 evaluate...
Detailed 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 a...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2018
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03245307
Start Date
August 22 2017
End Date
September 30 2018
Last Update
February 7 2018
Active Locations (1)
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1
Chinese Medical University First Hospital
Shenyang, Liaoning, China