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Trial Title:
Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms
NCT ID:
NCT05987956
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Alectinib
Conditions: Keywords:
ALK
EGFR
NSCLC
SNP
Pharmacogenomics
Gene
Genetics
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
- The usual approach group (NDC...01)
- The study approach group (NDC...86)
Primary purpose:
Health Services Research
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
No-placebo and random and double blind
Intervention:
Intervention type:
Drug
Intervention name:
Alectinib - Usual
Description:
Usual Alectinib Chemotherapy (NDC...01)
- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Arm group label:
Alectinib - Usual
Other name:
Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily
Intervention type:
Drug
Intervention name:
Alectinib - Study
Description:
Study Alectinib Chemotherapy (NDC...86)
- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Arm group label:
Alectinib - Study
Other name:
Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily
Summary:
Explore the relationship between drug target ALK gene single nucleotide polymorphisms and
ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer,
based on Oxford precisely sequencing drug targets' genes.
Explore the relationship between drug target CYP4503A4 gene single nucleotide
polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung
cancer, based on Oxford precisely sequencing drug targets' genes.
Detailed description:
The usual approach group, after biopsy diagnosis, 300 double blind random group separated
NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride
capsule 600 mg orally twice daily, it will try to look for the relationship between the
Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between
the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford
precisely sequencing drug targets' genes.
The study approach group, after biopsy diagnosis, 300 double blind random group separated
NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride
capsule 600 mg orally twice daily, it will try to look for the relationship between the
Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between
the Alectinib therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford
precisely sequencing drug targets' genes.
1. Detect drug target whole gene precision sequence of everyone patient for all 600
recruited double blind NSCLC patients.
2. Mutually compare everyone patient drug target whole gene precision sequence for a
total of 600 recruited double blind NSCLC patients.
3. Calculate drug target gene SNPs in all 600 recruited double blind NSCLC patients.
4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.
6. Mutually compare the usual approach group SNPs (300 double blind random group
separated NSCLC patients) with the study approach group SNPs (300 double blind
random group separated NSCLC patients).
7. Confirm the relationship between drug target gene SNPs and drug efficacy.
8. Confirm the relationship between drug target gene SNPs and drug safety.
Criteria for eligibility:
Criteria:
- Select 600 Non-Small Cell Lung Cancer Patients who are suitable for blood-drawing.
- Dosage Duration at least 90 days
- The usual approach group - Recruit 300 double blind random group separated NSCLC
patients currently used the Chemotherapy NDC...01 on ALECENSA - alectinib
hydrochloride capsule 600 mg orally twice daily, film coated after biopsy diagnosis,
like as the usual approach group.
- The study approach group - Recruit 300 double blind random group separated NSCLC
patients currently used the Chemotherapy NDC...86 on ALECENSA - alectinib
hydrochloride capsule 600 mg orally twice daily, film coated after biopsy diagnosis,
like as the study approach group.
Inclusion Criteria:
-
1. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)
-
2. Clinical biopsy diagnosis of NSCLC
-
3. Suitable for enough blood-drawing
-
4. Random and double blind
-
5. Measurable disease
-
6. Adequate organ functions
-
7. Adequate performance status
-
8. Age 22 years old and over
-
9. Sign an informed consent form
-
10. Receive blood-drawing
Exclusion Criteria:
-
1. Pneumonectomy
-
2. Treatment with other anti-cancer therapies and cannot be stopped currently
-
3. Pregnancy
-
4. Breast-feeding
-
5. The patients with other serious intercurrent illness or infectious diseases
-
6. Have more than one different kind of cancer at the same time
-
7. Serious Allergy to Drugs
-
8. Serious Bleed Tendency
-
9. Serious Risks or Serious Adverse Events of the drug product
-
10. The prohibition of drug products
-
11. Have no therapeutic effects
-
12. Follow up to the most current label
Gender:
All
Minimum age:
22 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Medicine Invention Design, Inc. - IORG0007849
Address:
City:
Rockville
Zip:
20853
Country:
United States
Contact:
Last name:
Han Xu, MD/PhD/FAPCR
Phone:
301-222-7143
Email:
hanxumd@gmail.com
Contact backup:
Last name:
HAN XU, MD/PhD/FAPCR
Phone:
301-326-8978
Email:
midinc@hotmail.com
Investigator:
Last name:
Han Xu, MD/PhD/FAPCR
Email:
Principal Investigator
Start date:
November 8, 2024
Completion date:
December 28, 2025
Lead sponsor:
Agency:
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
Agency class:
Industry
Collaborator:
Agency:
UnitedHealthcare
Agency class:
Other
Source:
Medicine Invention Design, Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05987956
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