Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01336062|
Recruitment Status : Completed
First Posted : April 15, 2011
Last Update Posted : May 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: Nanoparticle Albumin-Bound Paclitaxel||Phase 1 Phase 2|
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 3+1 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 A：125 mg /m2; Treatment arm B：100 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 < 1.5 m2，40mg，bid;BSA ≥ 1.5 m2，50mg，bid.
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 (Simon,1989), 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib/IIa, Two-stage Trial of ABI-007 Plus S-1 as Second-line Chemotherapy in Advanced Gastric Cancer Patients|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
Experimental: Nanoparticle Albumin-Bound Paclitaxel
The study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;
Drug: Nanoparticle Albumin-Bound Paclitaxel
this study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;
- adverse events [ Time Frame: during the treatment in the hosptital,an expected average of 3 weeks ]participants will be followed for the duration of hospital stay, an expected average of 3 weeks
- Objective response rate [ Time Frame: 6 weeks ]CT/MRI will be performed every 2 cycles of treatment for efficacy evaluation
- progression free survival [ Time Frame: 1 year ]the follow-up visit of PFS will be performed every 6 weeks
- overall survival of participants [ Time Frame: 2 years ]OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost
- biomarkers [ Time Frame: 6 weeks ]If the tumour samples available, to identify the molecular characteristics(such as SPARK,ABCG2,β-Tubulin III,PDGFRA,etc) of responding tumours by immunohistochemical, FISH, genomic and proteomic analysis; To study biomarkers expression before and during therapy and establish correlations with clinical outcome and toxicity;
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336062
|Beijing, Beijing, China, 100142|