Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Sorafenib Plus S-1 in Advanced Solid Tumors

This study has been completed.
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: October 16, 2015
Last verified: August 2012

May 20, 2010
October 16, 2015
November 2009
November 2009   (final data collection date for primary outcome measure)
Determination of MTD/RD [ Time Frame: First two cycles ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01128998 on ClinicalTrials.gov Archive Site
Dose-limiting Toxicity [ Time Frame: First two cycles ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Sorafenib Plus S-1 in Advanced Solid Tumors
An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors

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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
  • 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
Experimental: S-1 and Sorafenib
Interventions:
  • Drug: Sorafenib
  • Drug: S-1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
October 2015
November 2009   (final data collection date for primary outcome measure)

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.
Both
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01128998
NICR-CT2008-01
No
Not Provided
Not Provided
National Health Research Institutes, Taiwan
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
National Health Research Institutes, Taiwan
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP