Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment

NCT02646020 | Completed Phase 2 DMC

• 1 other identifier: TAPE001
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

Study hypothesis is that aprepitant is more effective than desloratadine in relieving pruritus caused by EGFR TKIs. Primary endpoint is the effective rate of pruritus, effective treatment defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score. 130 NSCLC patients undertaken EGFR-TKI and suffer from moderate or severe pruritus (VAS score ≥ 4) will be enrolled in this study, and stratified (gender, VAS 4-6 or 7-10, and 2nd generation TKI or non 2nd generation) randomized (1:1) into aprepitant or desloratadine treatment. VAS investigation will be taken once a week to treatment end (4 weeks).

Conditions

Non-small Cell Lung Cancer

Keywords

pruritus; Non-small Cell Lung Cancer; Receptor, Epidermal Growth Factor; tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• effective rate of pruritus relieving

  effective treatment of pruritus relieving defined as visual analogue scale (VAS) decrease ≥ 50% after treatment compared to baseline score

  day 28 at the treatment ends

Secondary Outcomes (2)

• duration of pruritus relieving

  12 weeks at the follow-up end

• Change from baseline quality of life assessment at treatment ends

  baseline, 28 days at the treatment ends

Study Arms (2)

Aprepitant and placebo

EXPERIMENTAL

aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;

Drug: Aprepitant; Drug: Placebo of desloratadine

desloratadine and placebo

ACTIVE COMPARATOR

placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28

Drug: Desloratadine; Drug: Placebo of aprepitant

Interventions

Aprepitant DRUG

aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Also known as: Treatment arm: Aprepitant administration

Aprepitant and placebo

Desloratadine DRUG

Desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Also known as: Treatment arm: Desloratadine administration

desloratadine and placebo

Placebo of aprepitant DRUG

Placebo of aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Also known as: Comparative arm: Placebo of aprepitant administration

desloratadine and placebo

Placebo of desloratadine DRUG

Placebo of desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)

Also known as: Comparative arm: Placebo of Desloratadine administration

Aprepitant and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced or metastatic non small cell lung cancer
• Undertaken EGFR TKIs treatment (gefitinib, erlotinib, icotinib, afatinib, etc)
• years old
• Eastern Cooperative Oncology Group (ECOG) performance score 0-2
• Moderate or severe pruritus (VAS score ≥ 4) first occur after EGFR TKIs treatment
• Life expectancy ≥ 3 months
• Orally drug administration with no difficulty
• pregnancy test negative in 7 days for women of child-bearing age; willing to take contraception measures.
• Signed informed consent form (ICF)

You may not qualify if:

• Systemically treatment with Neurokinin-1 (NK-1) receptor inhibitors, antihistamines drugs, antibiotics, cortical hormone therapy, antiepileptic drugs, immunosuppressive agents or other drugs might affect treatment in 4 weeks; or locally used of these drug in 2 weeks.
• Existing skin lesions not EGFR TKIs related, such as skin infection, chronic dermatitis, Systemic Lupus Erythematosus (SLE), lymphoma or other diseases.
• Total bilirubin ≥ 1.5 Upper Limit Of Normal (ULN)
• Serum creatinine ≥mg/dl
• AST or ALT ≥ 2.5 ULN without liver metastasis; or ≥ 5 ULN with liver metastasis.
• Residual toxicity event ≥ CTC-AE grade 2, except peripheral neurotoxicities.
• Central nervous system (CNS) metastasis or spinal compression; except no symptoms and with no cortical hormonotherapy in 4 weeks.
• Clinical evidence of interstitial lung disease
• Any severe or uncontrolled systemic diseases judged by investigators.
• Any contraindication of Neurokinin-1 receptor inhibitors and desloratadine.
• Discontinuation Criteria
• Invalid subject after randomization
• Major protocol violations judged by investigators.
• Poor compliance
• Intolerable adverse events

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun-Yat Sen University (CCSYSU)

Guangzhou, Guangdong, 510060, China

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Pruritus

Interventions

Aprepitant; desloratadine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Li Zhang, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Professor

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: January 5, 2016
• Study Start: December 1, 2015
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)