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

Phase 1
20 Years
75 Years
Open (Enrolling)
Advanced Solid Tumors

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Trial Information

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

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.

Type of Study:


Study Design:

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

Outcome Measure:

Determination of MTD/RD

Outcome Time Frame:

First two cycles

Safety Issue:


Principal Investigator

Li-Tzong Chen, M.D., Ph.D.

Investigator Role:

Study Chair

Investigator Affiliation:

National Institute of Cancer Research, National Health Research Institution, Taiwan


Taiwan: Department of Health

Study ID:




Start Date:

November 2009

Completion Date:

December 2012

Related Keywords:

  • Advanced Solid Tumors
  • Sorafenib
  • S1
  • Advanced Solid Tumors
  • RD
  • MTD
  • DLT
  • PK
  • PG
  • Biomarker
  • Neoplasms