Sorafenib Plus S-1 in Advanced Solid Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Cheng-Kung University Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT01128998
First received: May 20, 2010
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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: Allocation: Non-Randomized
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 ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2012 (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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01128998

Locations
Taiwan
National Cheng-Kung University Hospital
Tainan City, Taiwan, 704
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Cheng-Kung University Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT01128998     History of Changes
Other Study ID Numbers: NICR-CT2008-01
Study First Received: May 20, 2010
Last Updated: August 14, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Health Research Institutes, Taiwan:
Sorafenib
S1
Advanced Solid Tumors
RD
MTD
DLT
PK
PG
Biomarker

Additional relevant MeSH terms:
Neoplasms
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2014