Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Malignant Mesothelioma

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Antitussive Agents

Respiratory System Agents

Antineoplastic Agents

Levomethorphan

Dextromethorphan

Panobinostat

Histone Deacetylase Inhibitors

Enzyme Inhibitors

LBH589

Novartis Pharmaceuticals

This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients

Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma

A Phase IB, Open-Label, Multicenter Study to Investigate the Effect of Oral LBH589 on Dextromethorphan, a CYP2D6 Substrate, and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Tamoxifen

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Eun Sook Lee, MD, PhD

The purpose of this study is to investigate the impact of CYP2D6 Genotype on the clinical effects of tamoxifen using with samples from prospective randomized multicenter study(ASTRRA).

CYP2D6 Genotype on the Clinical Effect of Tamoxifen

Impact of CYP2D6 Genotype on the Clinical Effects of Tamoxifen Using With Samples From Prospective Randomized Multicenter Study

National Cancer Center, Korea

Korean Breast Cancer Study Group

Korea University Anam Hospital

Eun Sook, Lee

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Stimulants

Anti-Obesity Agents

Vasoconstrictor Agents

Other Dietary Supplements

Caffeine

Phosphodiesterase Inhibitors

Neurotransmitter Agents

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

Excitatory Amino Acid Antagonists

Analgesics, Opioid

Narcotics

Enzalutamide

Enzalutamide Placebo to Match (PTM)

Medical Director

This study evaluates how once daily enzalutamide affects the metabolism of caffeine and dextromethorphan in men with prostate cancer by measuring concentrations of these drugs and their metabolites in plasma.

This is an open-label, fixed-sequence, crossover drug-drug interaction study in subjects with prostate cancer.

Screening takes place between Day -28 and Day -7, and subjects are admitted to the clinic on Day -1 where they remain until Day 4.

On Day 1, they receive a single oral cocktail containing caffeine and dextromethorphan plus a dose of enzalutamide placebo in order to assess possible effects of excipients of the enzalutamide formulation. On Days 1 to 3 blood samples for pharmacokinetic (PK) assessment are collected. From Days 4 to 54, (or Day 55 if the subject rolls over into the extension study) the subjects take a daily oral dose of enzalutamide. On Day 28, the subjects return to the clinic where a plasma sample is taken to determine enzalutamide PK exposure. From Days 52 to 55 they are re-admitted to the clinic where a plasma sample is collected on Day 52 for enzalutamide PK exposure.On Day 53, subjects receive a single oral cocktail of caffeine and dextromethorphan concomitantly with enzalutamide. PK samples are collected from Days 53 to 55.

From Day 55 onwards, subjects experiencing clinical benefit may roll over into an extension study. Only subjects who enroll into the extension study continue to receive enzalutamide otherwise daily dosing with enzalutamide is discontinued on Day 54.

An End of Study Visit (ESV) takes place approximately 30 days (±7 days) after the last dose of enzalutamide.

A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer

A Phase 1 Open-label Study to Evaluate the Effect of Multiple Doses of Enzalutamide on the Pharmacokinetics of Substrates for CYP1A2 and CYP2D6 in Male Subjects With Prostate Cancer

For the probe substrates (caffeine and dextromethorphan) in combination with enzalutamide PTM and in combination with enzalutamide.

Tmax is time to maximum concentration. These PK parameters will be measured for the probe substrates (caffeine and dextromethorphan) in combination with enzalutamide PTM and in combination with enzalutamide.

For 1,7-dimethylxanthine (metabolite caffeine), dextrorphan (metabolite dextromethorphan).

For Enzalutamide, N-desmethyl enzalutamide (M2) and sum of enzalutamide + M2.

Medivation, Inc.

Astellas Pharma Europe B.V.

Increase tamoxifen dose into 40 mg/day for patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype.

Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.

Tamoxifen dose adjustment

Baitha P. Maggadani

The objectives of this study is to perform CYP2D6 genotyping and metabolite concentrations analysis on ER+ breast cancer patients who are taking tamoxifen and give dose recommendations based on the CYP2D6 genotypes and endoxifen levels.

Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels

Tamoxifen Dose Adjustment on ER+ Breast Cancer Patients Based on Genomic and Metabolite Concentrations Analysis

Nalagenetics Pte Ltd

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma	NCT00535951	Carcinoma, Non-... Mesothelioma	LBH589	18 Years -	Novartis
CYP2D6 Genotype on the Clinical Effect of Tamoxifen	NCT00973037	Breast Neoplasm... Tamoxifen Genotype CYP2D6	Tamoxifen	18 Years - 45 Years	Korea University Anam Hospital
A Study to Evaluate How Daily Dosing With Enzalutamide Affects the Metabolism of Caffeine and Dextromethorphan in Men With Prostate Cancer	NCT02225093	Pharmacokinetic... Pharmacokinetic... Prostate Cancer	Caffeine Dextromethorpha... Enzalutamide Enzalutamide Pl...	18 Years -	Astellas Pharma Inc
Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels	NCT04312347	ER+ Breast Canc...	Tamoxifen dose ...	18 Years -	Nalagenetics Pte Ltd
Tamoxifen Dose Adjustment on Indonesian Female ER+ Breast Cancer Patients Based on CYP2D6 Genotype and Endoxifen Levels	NCT04312347	ER+ Breast Canc...	Tamoxifen dose ...	18 Years -	Nalagenetics Pte Ltd

Spots Global Cancer Trial Database for cyp2d6

Every month we try and update this database with for cyp2d6 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cyp2d6

Every month we try and update this database with for cyp2d6 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cyp2d6 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.