Sorafenib Plus S-1 in Advanced Solid Tumors

This study has been completed.
National Cheng-Kung University Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan Identifier:
First received: May 20, 2010
Last updated: October 16, 2015
Last verified: August 2012

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.

Condition Intervention Phase
Advanced Solid Tumors
Drug: Sorafenib
Drug: S-1
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors

Resource links provided by NLM:

Further study details as provided by National Health Research Institutes, Taiwan:

Primary Outcome Measures:
  • Determination of MTD/RD [ Time Frame: First two cycles ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose-limiting Toxicity [ Time Frame: First two cycles ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: October 2015
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: S-1 and Sorafenib Drug: Sorafenib
  1. Name: Sorafenib
  2. Dosage form: 200 mg / Tablet
  3. Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1
Other Name: Nexavar
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
Other Name: TS-1


Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01128998

National Cheng-Kung University Hospital
Tainan City, Taiwan, 704
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Cheng-Kung University Hospital
Study Chair: Li-Tzong Chen, M.D., Ph.D. National Institute of Cancer Research, National Health Research Institution, Taiwan
  More Information

No publications provided

Responsible Party: National Health Research Institutes, Taiwan Identifier: NCT01128998     History of Changes
Other Study ID Numbers: NICR-CT2008-01
Study First Received: May 20, 2010
Last Updated: October 16, 2015
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Advanced Solid Tumors

Additional relevant MeSH terms:
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 27, 2015