Sorafenib Plus S-1 in Advanced Solid Tumors | NCT01128998

Studies
Sorafenib Plus S-1 in Advanced Solid Tumors

NCT01128998

Sponsor

National Health Research Institutes, Taiwan

Status

Completed

Last Update Posted

Oct 19, 2015Estimated

Enrollment

30Actual

Phase

Phase 1

Conditions

Advanced Solid Tumors

Interventions

Sorafenib
S-1

Countries

Taiwan

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

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Oct 2015Actual

First Submitted Date

May 20, 2010

First Submission Date that Met QC Criteria

May 20, 2010

First Posted Date

May 24, 2010Estimated

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

Oct 16, 2015

Last Update Posted Date

Oct 19, 2015Estimated

Name	Class
National Cheng-Kung University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Primary Objective:

To define the recommended dose for phase II study of S-1 combined with sorafenib
To evaluate the dose-limiting toxicities of the combination therapy

Secondary Objectives:

To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy
To investigate the impact of genetic polymorphisms of metabolic genes on the PK of sorafenib and S-1, respectively, as well as on the toxicity profile of the combination.
To determine the changes of biomarkers between pre- and post-treatments.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Label	Type	Description	Intervention Names
S-1 and Sorafenib	Experimental		Drug: Sorafenib Drug: S-1

Name	Type	Description	Arm Group Labels	Other Names
Sorafenib	Drug	Name: Sorafenib Dosage form: 200 mg / Tablet Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1	S-1 and Sorafenib

Measure	Description	Time Frame
Determination of MTD/RD		First two cycles

Measure	Description	Time Frame
Dose-limiting Toxicity		First two cycles

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically proven metastatic or locally advanced malignant solid tumors, which are refractory to current standard systemic treatment.
Have measurable lesion.
20-75 y/o.
ECOG performance score no more than 2.
Life expectancy > 12 weeks.
Adequate hematopoietic, hepatic and renal functions.
1. Hemoglobin > 9.0 g/dl
2. Absolute neutrophil count > 1,500/mm3
3. Platelet count 100,000/ mm3
4. Total bilirubin < 1.5 times the upper limit of normal (ULN)
5. ALT and AST < 2.5 x ULN
6. Serum creatinine < 1.0 x ULN
Recovery from prior therapy that given > 4 weeks before enrolment.
No pregnancy and breast-feeding.
Signed informed consent.

Exclusion Criteria:

Severe cardiovascular disorders.
Pulmonary fibrosis or interstitial pneumonia.
HIV infection.
Active infection.
Major anti-cancer treatment within 4 weeks of study entry.
Exposure to the current investigational agent before.
Known or suspected allergy to the current investigational agent.
Unable to swallow oral medications.
Substance abuse, medical, psychological or social conditions interfering with the patient's participation or evaluation of the study results.
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Symptoms of bowel obstruction, malnutrition, splenomegaly.
Receiving active anti-coagulant therapy.
Patients with concurrent CYP 2A6 and/or CYP 3A4 or 3A5 inducers or inhibitors; a minimal of 2 weeks wash-out period required.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000077157	Sorafenib
C079198	S 1 (combination)
C103828	titanium silicide

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