Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06326346
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-03-17
Brief Title:
GIST Oral PaclitaxelLiporaxel
Sponsor:
Asan Medical Center
Organization:
Asan Medical Center
Study Overview
Official Title:
A Phase II Study of Oral Paclitaxel Liporaxel in GIST Patients With a Low P-glycoprotein Expression After Failure With Imatinib Sunitinib and Regorafenib
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments including imatinib sunitinib and regorafenib and with low P-glycoprotein expression
Detailed Description:
The survival outcomes of patients with advanced andor metastatic gastrointestinal stromal tumors GIST have markedly improved with application of imatinib the KIT tyrosine kinase inhibitor GlivecTM Novartis for the treatment Recently sunitinib SuteneTM Pfizer and regorafenib StivargaTM Bayer have shown efficacy in patients with disease progression on imatinib as second- and third-line treatment respectively However most patients develop acquired resistance to KIT tyrosine kinase inhibitors and show disease progression
While cytotoxic chemotherapeutic agents were expected to have minimal antitumor effect on GIST recent preclinical studies have shown that 37 out of 89 different chemotherapeutic agents have shown antitumor effects on at least one or more GIST cell lines Especially topoisomerase II inhibitors paclitaxel bortezomib have shown promising results Based on the results the investigators conducted a single center single arm phase II study to evaluate efficacy and safety of paclitaxel for patients with GIST who failed to prior imatinib and sunitinib Overall efficacy was modest although patients with low P-glycoprotein expression showed better efficacy compared to those with high P-glycoprotein expression Subsequently the investigators performed another phase 2 trial to evaluate efficacy of paclitaxel for previously treated GIST patients with low P-glycoprotein expression and have met the primary endpoint
Liporaxel is an oral formulation of paclitaxel and showed high bioavailability safety and antitumor effect from non-clinical studies From a phase 1 clinical trial for metastatic solid tumor patients Liporaxel showed adequate PKPD profiles Compared to intravenous paclitaxel administration is relatively easier and has better safety in terms of hypersensitivity reaction which is caused by the admixture of intravenous formulation of paclitaxel From a multicenter phase 3 trial conducted in South Korea for patients with advanced gastric adenocarcinoma who failed on first-line palliative chemotherapy DREAM trial Liporaxel showed non-inferiority compared to intravenous paclitaxel in terms of both safety and efficacy and it is currently approved for the second-line treatment in advanced gastric cancer Also Liporaxel proved safety and potential efficacy in patients with HER2 negative metastatic breast cancer as first-line chemotherapy and currently multicenter phase 3 trial in ongoing OPTIMAL3 trial
The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments including imatinib sunitinib and regorafenib and with low P-glycoprotein expression
While cytotoxic chemotherapeutic agents were expected to have minimal antitumor effect on GIST recent preclinical studies have shown that 37 out of 89 different chemotherapeutic agents have shown antitumor effects on at least one or more GIST cell lines Especially topoisomerase II inhibitors paclitaxel bortezomib have shown promising results Based on the results the investigators conducted a single center single arm phase II study to evaluate efficacy and safety of paclitaxel for patients with GIST who failed to prior imatinib and sunitinib Overall efficacy was modest although patients with low P-glycoprotein expression showed better efficacy compared to those with high P-glycoprotein expression Subsequently the investigators performed another phase 2 trial to evaluate efficacy of paclitaxel for previously treated GIST patients with low P-glycoprotein expression and have met the primary endpoint
Liporaxel is an oral formulation of paclitaxel and showed high bioavailability safety and antitumor effect from non-clinical studies From a phase 1 clinical trial for metastatic solid tumor patients Liporaxel showed adequate PKPD profiles Compared to intravenous paclitaxel administration is relatively easier and has better safety in terms of hypersensitivity reaction which is caused by the admixture of intravenous formulation of paclitaxel From a multicenter phase 3 trial conducted in South Korea for patients with advanced gastric adenocarcinoma who failed on first-line palliative chemotherapy DREAM trial Liporaxel showed non-inferiority compared to intravenous paclitaxel in terms of both safety and efficacy and it is currently approved for the second-line treatment in advanced gastric cancer Also Liporaxel proved safety and potential efficacy in patients with HER2 negative metastatic breast cancer as first-line chemotherapy and currently multicenter phase 3 trial in ongoing OPTIMAL3 trial
The purpose of this study is to evaluate safety and efficacy of Liporaxel for patients with GIST who failed on prior standard treatments including imatinib sunitinib and regorafenib and with low P-glycoprotein expression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None