A Biomarker-implemented Clinical Study Evaluating Mutations in MET and TP53 in a Population of Treatment-refractory Squamous Cell Carcinoma
NCT ID: NCT04533321
Last Updated: 2020-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2020-09-30
2023-09-30
Brief Summary
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Detailed Description
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1. To determine the efficacy of afatinib in patients with germline MET-N375S polymorphism.
2. To determine the tolerability of afatinib in chemo-relapsed patients with germline MET-N375S polymorphism.
Research objectives:
1. To determine the prevalence of MET and TP53 mutations, as well as HER2 and MET amplification, in various cancers, particularly head and neck cancers and lung cancers.
2. To establish tumour cell lines, spheroids of xenografts for drug screening.
Endpoints of study:
1. To determine the response rate of SCC HN/lung with Met-N375S to afatinib.
2. The secondary endpoints include progression-free survival and toxicity.
3. Frequency of MET mutations and TP53 mutations in patients with cancer.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients genotyped positive for MET-N375S polymorphism
will be treated with orally administered daily dose of afatinib (Gilotrif®) in a fasting state (1 hour before or 2 hours after meals).
Afatinib
Afatinib is approved therapy for SCC of the lung after progression with standard of care chemotherapy.
Interventions
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Afatinib
Afatinib is approved therapy for SCC of the lung after progression with standard of care chemotherapy.
Eligibility Criteria
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Inclusion Criteria
1. Age 18 years or older
2. Histologic or cytologic confirmation of metastatic squamous cell carcinoma of the lung or head and neck region, and has failed standard treatment.
3. No other active malignancy within the past 24 months
4. All subjects must have at least one tumour lesion (primary or metastatic) that is suitable for free-hand or image-guided biopsy at baseline.
5. Clinical study will enroll patients genotyped positive for MET-N375S polymorphism.
6. Eastern Cooperative Oncology Group (ECOG) performance status \< 2
7. Adequate organ function as defined by:
a. Bone marrow function i. Haemoglobin ≥ 9g/dl ii. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L iii. Platelet count ≥ 75 x 109/L. b. Liver function i. Bilirubin \< 2.5x upper limit of normal (ULN) ii. Alanine transaminase (ALT) and aspartate transaminase (AST) \< 2.5x ULN or \< 5x ULN if liver metastases are present iii. Prothrombin time (PT) within the normal range for the institution. c. Renal function i. Plasma creatinine \<1.5x institutional ULN
8. Capable of swallowing tablets
9. Recovery from any previous drug- or procedure-related toxicity to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0 Grade 0 or 1 (except alopecia), or to baseline preceding the prior treatment.
10. Signed informed consent obtained before any study specific procedure. Subjects must be able to understand and be willing to sign the written informed consent.
Exclusion Criteria
2\. Pregnancy or breastfeeding. 3. Women of childbearing potential not employing adequate contraception. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of study medication, and a negative result must be documented before start of study medication. Women of childbearing potential and men, must agree to use adequate contraception (barrier method of birth control) upon signing the informed consent form until at least 3 months after the last study drug administration 4. Known or suspected allergy to the investigational agent or any agent given in association with this study.
5\. Concurrent cancer which is distinct in primary site or histology from the cancer being evaluated in this study 6. Patients with CTCAE Grade 2 or higher peripheral neuropathy. 7. History of significant cardiac disease: congestive cardiac failure \> NYHA class II, ongoing unstable angina, new-onset angina or myocardial infarction within the past 3 months
21 Years
99 Years
ALL
No
Sponsors
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National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Boon Cher Goh
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Boon Cher Goh
Role: primary
References
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Cancer Genome Atlas Research Network. Comprehensive genomic characterization of squamous cell lung cancers. Nature. 2012 Sep 27;489(7417):519-25. doi: 10.1038/nature11404. Epub 2012 Sep 9.
Liu Y, Zhang Q, Ren C, Ding Y, Jin G, Hu Z, Xu Y, Shen H. A germline variant N375S in MET and gastric cancer susceptibility in a Chinese population. J Biomed Res. 2012 Sep;26(5):315-8. doi: 10.7555/JBR.26.20110087. Epub 2012 Mar 29.
Other Identifiers
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MC01/02/20
Identifier Type: -
Identifier Source: org_study_id