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Trial record 46 of 143 for:    NIFEDIPINE

A Study To Test The Effect Of Apatinib On P450 Enzymes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03245307
Recruitment Status : Unknown
Verified July 2017 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : August 10, 2017
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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 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).

Condition or disease Intervention/treatment Phase
Cytochrome P450 Interaction Drug: Apatinib Drug: Nifedipine GTIS Drug: Warfarin Potassium Phase 1

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 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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : April 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Drug: Apatinib
Apatinib at a dosage of 750mg will be administered daily from day 9 of phase A

Drug: Nifedipine GTIS
Nifedipine at a dosage of 30mg will be administered at day 1 and day 14 of phase A
Other Name: Nifedipine

Drug: Warfarin Potassium
Nifedipine at a dosage of 3mg will be administered at day 3 and day 16 of phase A
Other Name: warfarin

Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of warfarin or nifedipine [ Time Frame: 1 year ]
    AUC0~t of warfarin and nifedipine in the absence or in presence of apatinib will be defined

Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Day 1 to 21 ( Phase A) ]
    to assess safety and tolerability of apatinib combined with warfarin or nifedipine in patients with advanced solid tumors. The vital signs, ECG, laboratory values and adverse events (AE and SAE) were judged according to NCI-CTCAE V4.0 criteria

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03245307

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China, Liaoning
Chinese Medical University First Hospital Recruiting
Shenyang, Liaoning, China
Contact: Yunpeng Liu    86024-83282802   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd. Identifier: NCT03245307     History of Changes
Other Study ID Numbers: HR-APTN-DDI-01
First Posted: August 10, 2017    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents