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Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer

Primary Purpose

Gastric Cancer.

Status

Available

Phase

Locations

Study Type

Expanded Access

Intervention

Phase I Dose-finding Study of Sorafenib Study

About this trial

This is an expanded access trial for Gastric Cancer. focused on measuring sorafenib, gastric cancer, FOLFOX4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

age >18 years.
documented gastric adenocarcinoma via histological or cytological examinations;
newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer;
no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; -
an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
an expected survival time of at least 3 months;
and provision of informed consent by patients prior to commencement of the study.

Exclusion Criteria:

a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix;
surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction;
severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy
a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation;
women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 New York Heart Association (NYHA) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection
epileptic patients requiring medical treatment (such as corticosteroids or antiepileptic drugs);
patients who had received immunotherapy within 4 weeks prior to or throughout the study or had received mitomycin C or nitrourea drugs within 4 weeks previously;
allergies or possible allergies to the study medications or other drugs administered during the study;
any patient safety or compliance issues that might jeopardize their participation in the study;
an inability to swallow oral drugs.

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT02209441

First Posted

August 4, 2014

Last Updated

August 4, 2014

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02209441

Brief Title

Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer

Study Type

Expanded Access

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Available

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

5. Study Description

Brief Summary

To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of sorafenib in combination with FOLFOX4 (oxaliplatin/leucovorin/5-fluorouracil) as first-line treatment for advanced gastric cancer The design of the study incorporated a standard 3 + 3 dose escalation procedure to guide elevation of the sorafenib dosage to the next level

Detailed Description

-Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 proved effective and safe for the treatment of advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer.

Keywords

sorafenib, gastric cancer, FOLFOX4

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Phase I Dose-finding Study of Sorafenib Study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Eligibility Criteria

Inclusion Criteria: age >18 years. documented gastric adenocarcinoma via histological or cytological examinations; newly diagnosed or recurrent unresectable advanced and metastatic gastric cancer; no history of chemotherapy or radiation therapy; at least one lesion with a measurable diameter; - an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; an expected survival time of at least 3 months; and provision of informed consent by patients prior to commencement of the study. Exclusion Criteria: a present or past medical history of other tumors, except for cured skin cancer (non-melanoma) or carcinoma in situ of the cervix; surgery, open biopsy, or obvious trauma within 28 days prior to enrolment; peritoneal seeding or intestinal obstruction; severe gastrointestinal bleeding; grade 1 or greater peripheral neuropathy a past medical history of serious neurological or psychiatric diseases; pregnancy or lactation; women of childbearing potential unwilling to use adequate contraception; a past medical history of heart disease such as greater than grade 2 New York Heart Association (NYHA) congestive heart failure, unstable coronary heart disease (patients having episodes of myocardial infarction earlier than 12 months prior to the study were allowed to enrol), arrhythmia requiring antiarrhythmic therapy (patients on β-blockers or digoxin were allowed to enrol), or uncontrolled hypertension; severe active infection epileptic patients requiring medical treatment (such as corticosteroids or antiepileptic drugs); patients who had received immunotherapy within 4 weeks prior to or throughout the study or had received mitomycin C or nitrourea drugs within 4 weeks previously; allergies or possible allergies to the study medications or other drugs administered during the study; any patient safety or compliance issues that might jeopardize their participation in the study; an inability to swallow oral drugs.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yihebali Chi, Doctor

Phone

+86 13911075626

yihebalichi@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Phase I Study of Sorafinib With Folfox4 as First-line Treatment in Advanced/Metastatic Gastric Cancer

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