Sorafenib Gastric Cancer Asian Phase I Study

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663741
• Other study ID #: 12931
• Status: Completed
• Phase: Phase 1
• First received: April 17, 2008
• Last updated: June 9, 2013
• Start date: May 2008
• Est. completion date: April 2010

Study information

• Verified date: June 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareKorea: Food and Drug AdministrationChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
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
• Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (25 mg/m2 bid, 3weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days / cycle
• Sorafenib (Nexavar, BAY43-9006)
Sorafenib (400 mg bid) + S-1 (40 mg/m2 bid, 3 weeks on / 1 week off) + CDDP (75 mg/m2 on Day 1) / 28 days cycle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and pharmacokinetics		20 weeks after start of treatment	Yes
Secondary	1 year survival rate		1 year after start of treatment	No
Secondary	Overall survival		1 year after start of treatment	No
Secondary	Progression free survival		1 year after start of treatment	No
Secondary	Response rate		1 year after start of treatment	No
Secondary	Duration of response		Time from initial Response to documented Tumor Progression	No

External Links

•   Click here and search for drug information provided by the FDA.
•   Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.