Sorafenib Plus S-1 in Advanced Solid Tumors

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborator: National Cheng-Kung University Hospital
• Treatments: Niacinamide; Sorafenib

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.