Sorafenib Plus S-1 in Advanced Solid Tumors

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: Sorafenib; Drug: S-1

• Registration Number: NCT01128998
• Lead Sponsor: National Health Research Institutes, Taiwan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2009-11
• Study First Submitted: 2010-05-20
• Study First Submitted QC: 2010-05-20
• Study First Posted: 2010-05-24
• Status Verified: 2012-08
• Study Completion: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
S-1 and Sorafenib	Sorafenib	-
S-1 and Sorafenib	S-1	-

Primary Outcome Measures

Name	Time	Method
Determination of MTD/RD	First two cycles

Secondary Outcome Measures

Name	Time	Method
Dose-limiting Toxicity	First two cycles

Trial Locations

Locations (1)

National Cheng-Kung University Hospital; 🇨🇳 Tainan City, Taiwan