Ignite Creation Date:
2024-05-05 @ 11:27 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01336062
Status:
COMPLETED
Last Update Posted:
2015-05-19
First Post:
2011-04-04
Brief Title:
Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Phase IbIIa Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric cancer have poor prognosis and majority of patients resistant to 5-FUDDP based first-line chemotherapy in China There was no recommended second-line chemotherapy for advanced gastric cancer Taxane is promising in gastric cancer Nanoparticle Albumin-Bound Paclitaxel AbraxaneABI-007 has good convenience to use and been approved in breast cancer in many countries The investigator then initiated a prospective phase IbIIa clinical trial with nab-paclitaxel plus TS-1 as the second-line treatment in advanced gastric cancer to observe the safety and efficacy
Detailed Description:
This study is a two-stage design Stage 1
The investigator should evaluate two recommend dose and tolerability of nab-paclitaxel plus S-1 after one course of treatment as 31 design
nab-paclitaxel should be given intravenously on days 1 and 8 at a dose as follows Treatment should be repeated every 3 weeks Treatment arm A125 mg m2 Treatment arm B100 mg m2 Treatment arm C 80 mg m2 S-1 should be given orally twice a day as follows for 14 consecutive days followed by a 1-week rest Treatment should be repeated every 3 weeks BSA 15 m240mgbidBSA 15 m250mgbid
The investigator should determine whether to continue the original regimen compare the safety and pharmacokinetic results with original profile of combination therapy to select the best therapy programs RD recommended dose
Stage 2 According to two-stage design Simon1989 re-entry subjects to the recommended dose group to a total of 25 valid cases If 11 patients achieve response then enter the second phase of total 66 patients
The investigator should evaluate two recommend dose and tolerability of nab-paclitaxel plus S-1 after one course of treatment as 31 design
nab-paclitaxel should be given intravenously on days 1 and 8 at a dose as follows Treatment should be repeated every 3 weeks Treatment arm A125 mg m2 Treatment arm B100 mg m2 Treatment arm C 80 mg m2 S-1 should be given orally twice a day as follows for 14 consecutive days followed by a 1-week rest Treatment should be repeated every 3 weeks BSA 15 m240mgbidBSA 15 m250mgbid
The investigator should determine whether to continue the original regimen compare the safety and pharmacokinetic results with original profile of combination therapy to select the best therapy programs RD recommended dose
Stage 2 According to two-stage design Simon1989 re-entry subjects to the recommended dose group to a total of 25 valid cases If 11 patients achieve response then enter the second phase of total 66 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None