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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
History of Changes
  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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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 May 21, 2013