A Study To Test The Effect Of Apatinib On P450 Enzymes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-22

Study Completion Date

2018-09-30

Brief Summary

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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).

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Detailed Description

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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).

Conditions

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Cytochrome P450 Interaction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treament

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.

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

Apatinib at a dosage of 750mg will be administered daily from day 9 of phase A

Nifedipine GTIS

Intervention Type DRUG

Nifedipine at a dosage of 30mg will be administered at day 1 and day 14 of phase A

Warfarin Potassium

Intervention Type DRUG

Nifedipine at a dosage of 3mg will be administered at day 3 and day 16 of phase A

Interventions

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Apatinib

Apatinib at a dosage of 750mg will be administered daily from day 9 of phase A

Intervention Type DRUG

Nifedipine GTIS

Nifedipine at a dosage of 30mg will be administered at day 1 and day 14 of phase A

Intervention Type DRUG

Warfarin Potassium

Nifedipine at a dosage of 3mg will be administered at day 3 and day 16 of phase A

Intervention Type DRUG

Other Intervention Names

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Nifedipine warfarin

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No