Clinical Pharmacogenetic Study of Sorafenib in Egyptian P... | NCT06527495

Studies
Clinical Pharmacogenetic Study of Sorafenib in Egyptian Patients With Hepatocellular Carcinoma

NCT06527495

Sponsor

Assiut University

Status

Recruiting

Last Update Posted

Jul 30, 2024Actual

Enrollment

150Estimated

Phase

Phase 1Phase 2

Conditions

HCC
Hepatocellular Carcinoma

Interventions

Sorafenib

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Jul 13, 2024

First Submission Date that Met QC Criteria

Jul 26, 2024

First Posted Date

Jul 30, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 26, 2024

Last Update Posted Date

Jul 30, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The current study will aim to maximize the therapeutic effect and to minimize the adverse effects of sorafenib in HCC through pharmacogenomic analysis of VEGFA and KDR genetic polymorphisms.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sorafenib	Experimental	Sorafenib 200 - 400 mg twice daily	Drug: Sorafenib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib	Drug	Sorafenib Tablets (200 -400 mg) twice daily	Sorafenib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vascular Endothelial Growth Factor A (VEGFA) genotyping	Genetic polymorphism of VEGFA	At Baseline, 3 month, and 6 month after treatment.
Kinase insert domain receptor (KDR) genotyping	Genetic polymorphism of KDR	At Baseline, 3 month, and 6 months after treatment.

Secondary Outcomes

Measure	Description	Time Frame
Tumor markers	Determination of serum Alpha-Fetoprotein, AFP-L3	At Baseline, 3 month, and 6 month after treatment.
Complete blood culture	Determination of hemoglobin concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age of all studied subjects ≥ 18 years old
All patients with hepatocellular carcinoma will be included in group I.
Patients not treated with systemic TKIs

Exclusion Criteria:

Patients presented with liver tumors other than HCC.
Patients with Child-Pugh grade C for liver function.
Patients with other malignancies.
Patients with chronic inflammatory disorders.
Patients with severe organ dysfunction such as heart, lung, and kidney.
Patients who cannot tolerate or are allergic to sorafenib.
Patients with severe coagulation dysfunction were uncorrectable.
Age less than 18 years old.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud Nazih	Contact	00201093859868		Mahmoud.Nazih5698@pharm.aun.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NLI	Recruiting	Shibīn al Kawm	Menoufia	32511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077157	Sorafenib

Ancestor Terms

ID	Term
D010671	Phenylurea Compounds
D014508	Urea
D000577	Amides
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided