Crizotinib for Lung Cancer

(Drugs-SNPs Trial)

Recruiting at 1 trial location

Overseen By Han Xu, MD/PhD/FAPCR

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Must be taking: Raloxifene

Must not be taking: Other anti-cancer therapies

Disqualifiers: Mastectomy, Pregnancy, Breast-feeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Explore the relationship between drug target ER gene single nucleotide polymorphisms and Raloxifene therapeutic effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target UGT gene single nucleotide polymorphisms and Raloxifene side-effects in patients with Breast Cancer LCIS, based on Oxford precisely sequencing drug targets' genes.

Who Is on the Research Team?

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Han Xu, MD/PhD/FAPCR

Principal Investigator

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Are You a Good Fit for This Trial?

This trial is for adults over 22 with non-small cell lung cancer (NSCLC) confirmed by a lung tissue biopsy. Participants must have measurable disease, good performance status, and proper organ function. They cannot be pregnant or breastfeeding, have serious bleeding tendencies or allergies to drugs, be undergoing other cancer treatments that can't stop, or have multiple cancers.

Inclusion Criteria

I am generally healthy and active.

My lung cancer was confirmed through a tissue biopsy.

Random and double blind

Exclusion Criteria

I have had a surgery to remove one of my lungs.

I have a condition that causes serious bleeding.

The prohibition of drug products

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Raloxifene 60 mg daily to assess therapeutic efficacy and safety related to SNP genotyping

12 weeks

Regular visits for monitoring and blood draws

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Crizotinib

Trial Overview The study investigates how genetic differences in the ALK gene and CYP4503A gene affect the effectiveness and side effects of Crizotinib in NSCLC patients. It involves precise gene sequencing and compares standard Crizotinib treatment against a study variant under double-blind conditions.

How Is the Trial Designed?

Group I: Raloxifene - Usual Experimental Treatment 1 Intervention

* Generic-1 - Raloxifene * Chemotherapy * Generic-1 - raloxifene hydrochloride tablet * Raloxifene 60 mg taken orally daily * Usual Approach Group (Generic-1)

Group II: Raloxifene - Study Experimental Treatment 1 Intervention

* Generic-2 - Raloxifene * Chemotherapy * Generic-2 - Raloxifene tablet * Raloxifene 60 mg taken orally daily * Usual Approach Group (Generic-2)

Crizotinib is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Approved in European Union as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Approved in Japan as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Approved in Canada as Xalkori for:

• Non-small cell lung cancer (NSCLC) with ALK rearrangements

Who Is Running the Clinical Trial?

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Lead Sponsor

Trials

6

Recruited

2,400+