Sorafenib Plus S-1 in Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01128998
• Other study ID #: NICR-CT2008-01
• Status: Completed
• Phase: Phase 1
• First received: May 20, 2010
• Last updated: October 16, 2015
• Start date: November 2009
• Est. completion date: October 2015

Study information

• Verified date: August 2012
• Source: National Health Research Institutes, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• Sorafenib
Name: Sorafenib Dosage form: 200 mg / Tablet Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1
• S-1
Name:S-1 Dosage form: 20 mg or 25 mg / Capsule Dosing schedule: 20-40 mg/m2 bid,po, 14 days on & 7 days off

Locations

Country	Name	City	State
Taiwan	National Cheng-Kung University Hospital	Tainan City

Sponsors (2)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan	National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determination of MTD/RD		First two cycles	Yes
Secondary	Dose-limiting Toxicity		First two cycles	Yes