Sorafenib Plus S-1 in Advanced Solid Tumors

NCT01128998 | Completed Phase 1

• 1 other identifier: NICR-CT2008-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

1. 1.To define the recommended dose for phase II study of S-1 combined with sorafenib
2. 2.To evaluate the dose-limiting toxicities of the combination therapy
3. 3.To characterize the pharmacokinetics (PK) of sorafenib and S-1 in the combination therapy
4. 4.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.
5. 5.To determine the changes of biomarkers between pre- and post-treatments.

Conditions

Advanced Solid Tumors

Keywords

Sorafenib; S1; Advanced Solid Tumors; RD; MTD; DLT; PK; PG; Biomarker

Outcome Measures

Primary Outcomes (1)

• Determination of MTD/RD

  First two cycles

Secondary Outcomes (1)

• Dose-limiting Toxicity

  First two cycles

Study Arms (1)

S-1 and Sorafenib

EXPERIMENTAL

Drug: Sorafenib; Drug: S-1

Interventions

Sorafenib DRUG

1. Name: Sorafenib 2. Dosage form: 200 mg / Tablet 3. Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1

Also known as: Nexavar

S-1 and Sorafenib

S-1 DRUG

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

Also known as: TS-1

S-1 and Sorafenib

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically proven metastatic or locally advanced malignant solid tumors, which are refractory to current standard systemic treatment.
• Have measurable lesion.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead
• National Cheng-Kung University Hospital: collaborator

Study Sites (1)

National Cheng-Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Interventions

Sorafenib; S 1 (combination); titanium silicide

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Li-Tzong Chen, M.D., Ph.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 24, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: October 1, 2015
• Last Updated: October 19, 2015

Record last verified: 2012-08

Locations

TW (1)