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Non-small Cell Lung CancerPhase 2EGFR-TKIsNCT02646020

Aprepitant vs. Desloratadine in EGFR-TKIs Related Pruritus Treatment

A Phase 2 study testing Aprepitant and Desloratadine in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Aprepitant and Desloratadine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteChina
Study dates
Dec 2015to 1 Dec 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Advanced or metastatic non small cell lung cancer
  • Undertaken EGFR TKIs treatment (gefitinib, erlotinib, icotinib, afatinib, etc)
  • 18 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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.
Show all 19Show fewer
  • 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
  • Subject withdraw ICF
  • Any pregnancy events
  • No clinical benefits due to clinical adverse events, laboratory abnormalities or other medical conditions
  • Other reasons of treatment discontinuation judged by investigators.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center of Sun-Yat Sen University (CCSYSU)

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Aprepitant vs. Desloratadine in Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Related Pruritus: A Prospective, Randomized Control, Double-blinded, Phase II Clinical Trial

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).

Read the detailed description

This is a prospective, randomized control, double-blinded, phase II clinical trial. 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 (1 week) compared to baseline score. The VAS inquiry will be taken once a week for 4 weeks. Quality of life investigation will be performed at baseline, 1 week and 4 weeks after treatment using SKINDEX-16 questionnaire. 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,and VAS 4-6 or 7-10, and 2nd generation TKI or non 2nd generation) randomized (1:1) into aprepitant or desloratadine treatment. Aprepitant arm will be administrated aprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28; desloratadine arm will be administrated placebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28. Tolerance evaluation will be taken according to National Cancer Institute (NCI)-Common Terminology Criteria (CTC) For Adverse Events (AE) V4.03.

Being tested
Aprepitant, Desloratadine, Placebo of aprepitant, Placebo of desloratadine
Keywords
pruritus, Non-small Cell Lung Cancer, Receptor, Epidermal Growth Factor, tyrosine kinase inhibitor
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pruritus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AprepitantDrug

    Also called Treatment arm: Aprepitant administration

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

  • DesloratadineDrug

    Also called Treatment arm: Desloratadine administration

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

  • Placebo of aprepitantDrug

    Also called Comparative arm: Placebo of aprepitant administration

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

  • Placebo of desloratadineDrug

    Also called Comparative arm: Placebo of Desloratadine administration

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

Study groups in NCT02646020
Study groupRoleWhat they receive
Aprepitant and placeboExperimentalaprepitant 125mg d1, 80mg d3 and d5, along with placebo 5mg d1-d28;
Receives: Drug: Aprepitant; Drug: Placebo of desloratadine
desloratadine and placeboActive comparatorplacebo 125mg d1, 80mg d3 and d5, along with desloratadine 5mg d1-d28
Receives: Drug: Desloratadine; Drug: Placebo of aprepitant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: day 28 at the treatment ends

Secondary outcomes (2)

  1. duration of pruritus relieving

    the time from pruritus effective relief to VAS score increase ≥ baseline level, the VAS inquiry will be taken once a week.

    Measured: 12 weeks at the follow-up end

  2. Change from baseline quality of life assessment at treatment ends

    using SKINDEX-16 questionnaire to assess patients quality of life

    Measured: baseline, 28 days at the treatment ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2016 (estimated)
  2. Study startDec 2015
  3. Primary completion1 Oct 2020
  4. Study completion1 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02646020
Sponsor's protocol ID
TAPE001
Acronym
EGFR-TKIs
Status last verified
May 2021
First submitted
10 Dec 2015
Last updated
18 May 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Mok TS, Wu YL, Thongprasert S, Yang CH, Chu DT, Saijo N, Sunpaweravong P, Han B, Margono B, Ichinose Y, Nishiwaki Y, Ohe Y, Yang JJ, Chewaskulyong B, Jiang H, Duffield EL, Watkins CL, Armour AA, Fukuoka M. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009 Sep 3;361(10):947-57. doi: 10.1056/NEJMoa0810699. Epub 2009 Aug 19.

    PubMed 19692680

  • Zhou C, Wu YL, Chen G, Feng J, Liu XQ, Wang C, Zhang S, Wang J, Zhou S, Ren S, Lu S, Zhang L, Hu C, Hu C, Luo Y, Chen L, Ye M, Huang J, Zhi X, Zhang Y, Xiu Q, Ma J, Zhang L, You C. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2011 Aug;12(8):735-42. doi: 10.1016/S1470-2045(11)70184-X. Epub 2011 Jul 23.

    PubMed 21783417

  • Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.

    PubMed 16014882

  • Cappuzzo F, Ciuleanu T, Stelmakh L, Cicenas S, Szczesna A, Juhasz E, Esteban E, Molinier O, Brugger W, Melezinek I, Klingelschmitt G, Klughammer B, Giaccone G; SATURN investigators. Erlotinib as maintenance treatment in advanced non-small-cell lung cancer: a multicentre, randomised, placebo-controlled phase 3 study. Lancet Oncol. 2010 Jun;11(6):521-9. doi: 10.1016/S1470-2045(10)70112-1. Epub 2010 May 20.

    PubMed 20493771

  • Zhang L, Ma S, Song X, Han B, Cheng Y, Huang C, Yang S, Liu X, Liu Y, Lu S, Wang J, Zhang S, Zhou C, Zhang X, Hayashi N, Wang M; INFORM investigators. Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial. Lancet Oncol. 2012 May;13(5):466-75. doi: 10.1016/S1470-2045(12)70117-1. Epub 2012 Apr 17.

    PubMed 22512843

  • Lynch TJ Jr, Kim ES, Eaby B, Garey J, West DP, Lacouture ME. Epidermal growth factor receptor inhibitor-associated cutaneous toxicities: an evolving paradigm in clinical management. Oncologist. 2007 May;12(5):610-21. doi: 10.1634/theoncologist.12-5-610.

    PubMed 17522250

  • Lacouture ME, Anadkat MJ, Bensadoun RJ, Bryce J, Chan A, Epstein JB, Eaby-Sandy B, Murphy BA; MASCC Skin Toxicity Study Group. Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Support Care Cancer. 2011 Aug;19(8):1079-95. doi: 10.1007/s00520-011-1197-6. Epub 2011 Jun 1.

    PubMed 21630130

  • Chan A, Tan EH. How well does the MESTT correlate with CTCAE scale for the grading of dermatological toxicities associated with oral tyrosine kinase inhibitors? Support Care Cancer. 2011 Oct;19(10):1667-74. doi: 10.1007/s00520-010-0999-2. Epub 2010 Sep 5.

    PubMed 20820812

  • Ocvirk J, Cencelj S. Management of cutaneous side-effects of cetuximab therapy in patients with metastatic colorectal cancer. J Eur Acad Dermatol Venereol. 2010 Apr;24(4):453-9. doi: 10.1111/j.1468-3083.2009.03446.x. Epub 2009 Sep 27.

    PubMed 19793151

  • Scope A, Agero AL, Dusza SW, Myskowski PL, Lieb JA, Saltz L, Kemeny NE, Halpern AC. Randomized double-blind trial of prophylactic oral minocycline and topical tazarotene for cetuximab-associated acne-like eruption. J Clin Oncol. 2007 Dec 1;25(34):5390-6. doi: 10.1200/JCO.2007.12.6987.

    PubMed 18048820

  • Porzio G, Aielli F, Verna L, Porto C, Tudini M, Cannita K, Ficorella C. Efficacy of pregabalin in the management of cetuximab-related itch. J Pain Symptom Manage. 2006 Nov;32(5):397-8. doi: 10.1016/j.jpainsymman.2006.07.006. No abstract available.

    PubMed 17085262

  • Stander S, Siepmann D, Herrgott I, Sunderkotter C, Luger TA. Targeting the neurokinin receptor 1 with aprepitant: a novel antipruritic strategy. PLoS One. 2010 Jun 4;5(6):e10968. doi: 10.1371/journal.pone.0010968.

    PubMed 20532044

  • Stander S, Weisshaar E. Medical treatment of pruritus. Expert Opin Emerg Drugs. 2012 Sep;17(3):335-45. doi: 10.1517/14728214.2012.711316. Epub 2012 Aug 7.

    PubMed 22870909

  • Chang SE, Han SS, Jung HJ, Choi JH. Neuropeptides and their receptors in psoriatic skin in relation to pruritus. Br J Dermatol. 2007 Jun;156(6):1272-7. doi: 10.1111/j.1365-2133.2007.07935.x.

    PubMed 17535226

  • Quartara L, Altamura M. Tachykinin receptors antagonists: from research to clinic. Curr Drug Targets. 2006 Aug;7(8):975-92. doi: 10.2174/138945006778019381.

    PubMed 16918326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aprepitant and Desloratadine in people with Non-small Cell Lung Cancer, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effective rate of pruritus relieving (time frame: day 28 at the treatment ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02646020, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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