Sorafenib Plus S-1 in Advanced Solid Tumors

NCT ID: NCT01128998

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2015-10-31

Brief Summary

Primary Objective:

1. To define the recommended dose for phase II study of S-1 combined with sorafenib

2. To evaluate the dose-limiting toxicities of the combination therapy

Secondary Objectives:

1. To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy

2. 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.

3. To determine the changes of biomarkers between pre- and post-treatments.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1 and Sorafenib

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

1. Name: Sorafenib

2. Dosage form: 200 mg / Tablet

3. Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1

S-1

Intervention Type: DRUG

1. Name:S-1

2. Dosage form: 20 mg or 25 mg / Capsule

3. Dosing schedule: 20-40 mg/m2 bid,po, 14 days on & 7 days off

Interventions

Sorafenib

1. Name: Sorafenib

2. Dosage form: 200 mg / Tablet

3. Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1

Intervention Type: DRUG

S-1

1. Name:S-1

2. Dosage form: 20 mg or 25 mg / Capsule

3. Dosing schedule: 20-40 mg/m2 bid,po, 14 days on & 7 days off

Intervention Type: DRUG

Other Intervention Names

Nexavar; TS-1

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li-Tzong Chen, M.D., Ph.D.

Role: STUDY_CHAIR

National Institute of Cancer Research, National Health Research Institution, Taiwan

Locations

National Cheng-Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

NICR-CT2008-01

Identifier Type: -

Identifier Source: org_study_id