Sorafenib Gastric Cancer Asian Phase I Study
Phase I Study to Investigate Safety, Pharmacokinetics and Preliminary Efficacy Profile of Sorafenib (BAY 43-9006) in Combination With S-1 Plus CDDP in Asian Patients With Unresectable / Recurrent Gastric Cancer
1 other identifier
interventional
13
1 country
3
Brief Summary
This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 gastric-cancer
Started May 2008
Shorter than P25 for phase_1 gastric-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2008
CompletedFirst Posted
Study publicly available on registry
April 22, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJune 11, 2013
June 1, 2013
1.8 years
April 17, 2008
June 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and pharmacokinetics
20 weeks after start of treatment
Secondary Outcomes (5)
1 year survival rate
1 year after start of treatment
Overall survival
1 year after start of treatment
Progression free survival
1 year after start of treatment
Response rate
1 year after start of treatment
Duration of response
Time from initial Response to documented Tumor Progression
Study Arms (3)
Arm 1
EXPERIMENTALArm 2
EXPERIMENTALArm 3
EXPERIMENTALInterventions
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 2 weeks off) + CDDP (60 mg/m2 on Day 8) / 35 days / cycle
Eligibility Criteria
You may qualify if:
- Histological or cytological confirmation of the primary unresectable or recurrent gastric cancer (both with and without measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) are allowed). Peritoneal dissemination without ascites is allowed.
- No prior systemic anticancer therapy including chemotherapy, immunotherapy, targeted agents or experimental therapies for advanced disease
- Prior adjuvant therapy/neo adjuvant therapy is allowed if recurrence occurred 6 months after completion of these therapies
- Age \>/= 18 years and \< 75 years
You may not qualify if:
- Known brain metastasis, spinal cord compression or meningeal carcinomatosis.
- Clinically relevant ascites
- Concurrent cancer that is distinct in primary site or histology from gastric cancer
- Any condition that impairs patient's ability to swallow whole pills
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (3)
Unknown Facility
Kashiwa, Chiba, 277-8577, Japan
Unknown Facility
Kobe, Hyōgo, 650-0017, Japan
Unknown Facility
Chuo-ku, Tokyo, 104-0045, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 17, 2008
First Posted
April 22, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
June 11, 2013
Record last verified: 2013-06