Ignite Creation Date:
2024-05-06 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03698825
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2018-09-27
Brief Title:
TEW-7197 With Paclitaxel for the Treatment of Metastatic Gastric Cancer
Sponsor:
MedPacto Inc
Organization:
MedPacto Inc
Study Overview
Official Title:
An Open-label Multicenter Phase Ib2a Study of TEW-7197 Vactosertib Plus Weekly Paclitaxel as Second-line Treatment for Metastatic Gastric Adenocarcinoma
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This is an open-label single arm study evaluating the safety and tolerability of TEW-7197 in combination with paclitaxel in metastatic gastric cancer patients
Detailed Description:
In the dose escalation step phase 1b 3 subjects are registered for each dose step and the DLT is evaluated by administering the investigational product for 1 cycle 28 days However for reasons other than toxicity related to the test drug the patient was given a combination of Paclitaxel and TEW-7197 Vactosertib during the DLT evaluation period during the first cycle of the planned TEW-7197
If more than 80 of the administered dose of Vactosertib is not administered the patient will be considered unevaluable for DLT and another patient will be enrolled At the end of one cycle of each cohort the SMC decides whether to proceed to the next cohort After completing the DLT evaluation of the final phase 1 cohort the recommended dose to proceed in the dose expansion phase Phase 2a is determined For subjects who have completed one cycle DLT evaluation period administer the investigational drug at the same dose until disease progression or unacceptable toxicity occurs Tumor imaging CT or MRI for tumor evaluation is performed after screening and C1D1 Assessment every 6 weeks 2 weeks and at the end of treatment EOTDC As efficacy evaluation items PFS OS ORR and DCR are evaluated according to RECIST 11 and the amount of change in the biomarker is confirmed
In the dose expansion phase phase 2a 50 patients will be enrolled at the dose determined in the dose escalation phase Tumor imaging CT or MRI for tumor evaluation is evaluated every 6 weeks 2 weeks after screening and C1D1 and at the end of treatment EOTDC As validity evaluation items PFS OS ORR and DCR according to RECIST 11 are evaluated and the amount of change in the biomarker is confirmed
If more than 80 of the administered dose of Vactosertib is not administered the patient will be considered unevaluable for DLT and another patient will be enrolled At the end of one cycle of each cohort the SMC decides whether to proceed to the next cohort After completing the DLT evaluation of the final phase 1 cohort the recommended dose to proceed in the dose expansion phase Phase 2a is determined For subjects who have completed one cycle DLT evaluation period administer the investigational drug at the same dose until disease progression or unacceptable toxicity occurs Tumor imaging CT or MRI for tumor evaluation is performed after screening and C1D1 Assessment every 6 weeks 2 weeks and at the end of treatment EOTDC As efficacy evaluation items PFS OS ORR and DCR are evaluated according to RECIST 11 and the amount of change in the biomarker is confirmed
In the dose expansion phase phase 2a 50 patients will be enrolled at the dose determined in the dose escalation phase Tumor imaging CT or MRI for tumor evaluation is evaluated every 6 weeks 2 weeks after screening and C1D1 and at the end of treatment EOTDC As validity evaluation items PFS OS ORR and DCR according to RECIST 11 are evaluated and the amount of change in the biomarker is confirmed
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