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Completed

NCT Number: NCT01128998

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count > 1,500/mm3
  • Platelet count 100,000/ mm3
  • Total bilirubin < 1.5 times the upper limit of normal (ULN)
  • ALT and AST < 2.5 x ULN
  • 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.

Treatment and study plan

Sorafenib

Drug
  • Name: Sorafenib
  • Dosage form: 200 mg / Tablet
  • Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1

Other names: Nexavar

S-1

Drug
  • Name:S-1
  • Dosage form: 20 mg or 25 mg / Capsule
  • Dosing schedule: 20-40 mg/m2 bid,po, 14 days on & 7 days off

Other names: TS-1

Primary outcomes

  1. Determination of MTD/RD

    Time frame: First two cycles

Secondary outcomes

  1. Dose-limiting Toxicity

    Time frame: First two cycles

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Collaborators

  • National Cheng-Kung University Hospital

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2015
First posted
May 24, 2010
Registry last updated
Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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