Skin and Connective Tissue Diseases

Symptoms and General Pathology

All Conditions

Pruritus

Skin Diseases

Skin Manifestations

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antineoplastic Agents

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Fosaprepitant

Aprepitant

Prednisone

Histamine Antagonists

Histamine H1 Antagonists

Diphenhydramine

Promethazine

Fexofenadine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Neurokinin-1 Receptor Antagonists

Substance P

Neurokinin A

Neurotransmitter Agents

Histamine

Histamine phosphate

Histamine H1 Antagonists, Non-Sedating

Aprepitant is administered in patients ,affected by solid tumors treated with biological therapy, who did not receive any treatment for severe pruritus

Aprepitant will be administered in patient affected by severe itch resistant to standard treatment (steroids and/or antihistamines) administered for at least one week

125 mg on day 1; 80 mg on day 3; 80 mg on day 5

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)

Daniele Santini, MD, PhD

Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

Investigators enroll patients affected by solid tumors which present itch refractory to standard treatment ("refractory group") and patients who did not receive any treatment for pruritus ("naïve group"). The intensity of itch will be evaluated with Visual Analogue Scale (VAS) score. In the refractory group Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) will be administered after at least 1 week of standard systemic treatment. In the naïve group, Aprepitant will be administered after the first onset of severe pruritus. The primary end point is to evaluate the effect of aprepitant in managing pruritus both in naive and refractory group.

Aprepitant in the Management of Biological Therapies-related Severe Pruritus

Aprepitant in the Management of Biological Therapies-related Severe Pruritus: a Pilot Study in 45 Cancer Patients

Patients is asked to grade the intensity of their itch on the VAS, with the strongest possible itch marked at the right end of the line (10) and no itch marked at the left end (0). The VAS score is registered in a diary supplied 7 days before starting the study and every week throughout the study period.

Pruritus intensity is evaluated by VAS score once before Aprepitant administration, once 7 days after the first dose of Aprepitant and once a week until the end of biological therapy or the pruritus recurrence. Response (evaluated one week after the first Aprepitant dose) is defined as \> 50% reduction of pruritus intensity compared to the baseline value.

Campus Bio-Medico University

MD, PhD

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Obesity Agents

Vasoconstrictor Agents

Respiratory System Agents

Anti-Infective Agents

Osimertinib

Phenylpropanolamine

Guaifenesin

Chlorpheniramine, phenylpropanolamine drug combination

polysaccharide-K

Sequential treatments of fexofenadine alone followed by osimertinib + fexofenadine, followed by osimertinib alone, followed by osimertinib + fexofenadine

Fexofenadine (P-gp substrate) 120mg taken once daily on Days 1 in Treatment Period 1 and Day 1 and Day 39 in Treatment Period 2

Fexofenadine tablet dosing

Osimertininb 80 mg taken once daily on Day 1 and Days 4 to 41 in Treatment Period 2

Osimertininb tablet dosing

Emiliano C Aller, M.D., Ph.D.

This is a Phase I, open-label, 2-part study in patients with a confirmed diagnosis of epidermal growth factor receptor (EGFR) mutation positive (EGFRm+) non-small cell lung cancer (NSCLC), who have progressed following prior therapy with an approved EGFR tyrosine kinase inhibitor (TKI) agent.

Part A will assess the effect of osimertinib on the pharmacokinetic (PK) parameters of fexofenadine, following single and multiple oral dosing of osimertinib in a fasted state.

Continuous Access will allow patients further access to osimertinib after the PK phase (Part A). All patients from Part A who completed treatment may continue to receive osimertinib 80 mg once daily until: they are no longer deriving clinical benefit; or any other reason

This is a Phase I, open-label, non-randomised, two-part study in patients with EGFRm+ NSCLC who have progressed on an EGFR-TKI.

The PK phase will assess the effect of osimertinib on the PK parameters of fexofenadine following both single and multiple oral dosing of osimertinib. Continued access will provide patients with further access to osimertinib after the PK phase.

The study will be conducted at approximately 10 sites across Asia and Western Europe, with approximately 24 patients enrolled in order to achieve at least 18 evaluable patients. Additional patients may be dosed to ensure the minimum number of evaluable patients.

PK phase The PK phase is a non-randomised, open-label, 2-period design. Treatment Period 1 and Treatment Period 2 are separated by a 3 to 7 day washout period between doses. A study flow chart for the PK phase is presented in Figure 1. Patients will receive osimertinib 80 mg as a single dose on Day 1 of Treatment Period 2, then 80 mg once daily for 38 days (from Day 4 to Day 41 in Treatment Period 2). Patients will also receive a single oral dose of fexofenadine on Day 1 in Treatment Period 1, and on Days 1 and 39 in Treatment Period 2.

Continued access On completion of the PK phase (ie, following collection of the 72-hour fexofenadine sample on Day 42), patients may continue to take osimertinib tablets (80 mg once daily) as a single agent in continued access if they and the Investigator agree that this is appropriate. This will continue until the Investigator believes they are no longer deriving clinical benefit, or they stop taking osimertinib for any other reason. No clinical data will be collected during this phase other than sudden death of unknown reason, serious adverse events (SAEs) that may be related to osimertinib, outcomes of pregnancy and drug dispensing/accountability.

If a patient discontinues treatment during the PK phase, they will return to the clinic for follow-up assessments 30 days (±7 days) after their last dose of treatment in the PK phase. If the patient's last dose of osimertinib is in continued access, the patient should be contacted 30 days after their last dose of osimertinib to follow-up any existing SAEs, monitor for new SAEs that may be related to the IP, and record any sudden deaths of unknown cause.

Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC

An Open-label, Non-randomised, Phase I Study to Assess the Effect of Single and Multiple Oral Doses of Osimertinib (TAGRISSO™) on the Pharmacokinetics of a P-glycoprotein Probe Drug (Fexofenadine) in Patients With Advanced EGFRm NSCLC That Have Progressed on a Prior EGFR-TKI Regimen

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

To characterize the pharmacokinetics of fexofenadine by assessment of maximum plasma fexofenadine concentration.

To characterize the pharmacokinetics of fexofenadine by assessment of area under the plasma concentration time curve from zero to infinity

To characterize the pharmacokinetics of fexofenadine by assessment of time to reach maximum plasma concentration

To characterize the pharmacokinetics of fexofenadine by assessment of area under plasma concentration-time curve from time zero to the last quantifiable time point

To characterize the pharmacokinetics of fexofenadine by assessment of apparent plasma clearance following oral administration

To characterize the pharmacokinetics of fexofenadine by assessment of apparent volume of distribution

To characterize the pharmacokinetics of fexofenadine by assessment of terminal rate constant

To characterize the pharmacokinetics of fexofenadine by assessment of terminal half-life

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of trough concentrations

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of area under plasma concentration-time curve from time zero to 72 hours post-dose

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of maximum plasma drug concentration

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of Time to reach maximum plasma concentration

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of metabolite to parent ratio (AZ5104:osimertinib, AZ7550:osimertinib) maximum plasma drug concentration

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of area under plasma concentration time curve during the dosing interval

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of maximum plasma concentration at steady state

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of minimum plasma concentration at steady state

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of apparent plasma clearance following oral administration at steady state

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of metabolite to parent ratio (AZ5104:osimertinib, AZ7550:osimertinib) area under plasma concentration time curve during the dosing interval

To characterize the pharmacokinetics of osimertinib and metabolites (AZ5104 and AZ7550) by assessment of metabolite to parent ratio (AZ5104:osimertinib, AZ7550:osimertinib) maximum plasma concentration at steady state

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aprepitant in the Management of Biological Therapies-related Severe Pruritus	NCT01683552	ITCH	Aprepitant Prednisone Fexofenadine	18 Years - 85 Years	Campus Bio-Medico University
Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC	NCT02908750	Non Small Cell ...	Fexofenadine ta... Osimertininb ta...	18 Years - 130 Years	AstraZeneca
Study to Assess the Effect of Osimertinib (TAGRISSO™ ) on Blood Levels of Fexofenadine in Patients With EGFRm+ NSCLC	NCT02908750	Non Small Cell ...	Fexofenadine ta... Osimertininb ta...	18 Years - 130 Years	AstraZeneca

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