Ignite Creation Date:
2024-05-06 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03666832
Status:
UNKNOWN
Last Update Posted:
2022-06-15
First Post:
2018-09-10
Brief Title:
Multi-center Open-label Phase 1b Clinical Trial to Evaluate the Safety Tolerability and Exploratory Efficacy of TEW-7197 in Combination With FOLFOX in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed First-Line Gemcitabine and Nab-Paclitaxel
Sponsor:
Joon Oh Park
Organization:
Samsung Medical Center
Study Overview
Official Title:
Multi-center Open-label Phase 1b Clinical Trial to Evaluate the Safety Tolerability and Exploratory Efficacy of TEW-7197 in Combination With FOLFOX in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed First-Line Gemcitabine and Nab-Paclitaxel
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
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:
MP-PDAC-01
Brief Summary:
Inclusion
1 Subjects who are males or females 19 years of age
2 Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma
3 Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial
4 Subjects who have the following laboratory test values
bilirubin 15 x ULN upper limit of normal
aspartate aminotransferase AST and alanine aminotransferase ALT 5 x ULN
serum creatinine 15 x ULNor estimated creatinine clearance 40 mLmin Cockcroft-Gault
partial thromboplastin time aPTT 15 x ULN
absolute neutrophil count ANC 1500 cellsµL
platelet count 100000µL
hemoglobin 90 gdL
5 Subjects who have at least a 12-week life expectancy at the Investigators discretion
6 Subjects who have Eastern Cooperative Oncology Group ECOGPerformance Status 0-1
Exclusion
1 Subjects who were treated with surgery radiotherapy chemotherapy or investigational therapy within 2 weeks note placement of biliary stent is allowed
2 Subjects who have uncontrolled CNS metastases patients who require steroids should be on a stable or decreasing dose for at least 2 weeks
3 Subjects who have any contraindications for 5-FU leucovorin or oxaliplatin
4 Subjects who have moderate or severe cardiovascular disease
Subjects who have myocardial infarction unstable angina pectoris New York Heart Association NYHA Class IIIIV congestive heart failure or uncontrolled hypertension within 6 months before screening
Subjects who have major abnormalities at the Investigators discretion based on electrocardiogram ECGand Doppler ECHO results at screening or within 14 days before screening
Subjects who have increase in brain natriuretic peptideBNP or increase in troponin over 99th percentile upper reference limit at Screening based on the normal range of relevant study center
Subjects who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis
Subjects who have a history of heart or aorta surgery
5 Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening
6 Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drugs
7 Subjects who have received prior treatment targeting the signaling pathway of TGF-β
8 Subjects who have a disease or condition that affects the mechanism of the investigational product or are currently using or planning to use
Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme CYP including CYP1A2 CYP2B6 or CYP3A4
Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase UGT 1A1 UGT1A1
Drugs that are substrates for the drug transporter multidrug resistance protein 1 MDR1 have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1
Drugs that are strong inhibitors or inducers of CYP2D6 or CYP3A4
9 Subjects who are unable to swallow tablets
10 Subjects who have a history of or are suspected of drug abuse
11 Female subjects of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period eg sterilization intrauterine contraceptive device combination of oral contraception and barrier contraception combination of other hormone delivery systems and barrier contraception contraceptive cream combination of cream jelly or form and diaphragm or condom
12 Subjects in the opinion of the Investigator who are unsuitable to participate in the study
13 Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-timesthe half-life of the investigational product
1 Subjects who are males or females 19 years of age
2 Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma
3 Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial
4 Subjects who have the following laboratory test values
bilirubin 15 x ULN upper limit of normal
aspartate aminotransferase AST and alanine aminotransferase ALT 5 x ULN
serum creatinine 15 x ULNor estimated creatinine clearance 40 mLmin Cockcroft-Gault
partial thromboplastin time aPTT 15 x ULN
absolute neutrophil count ANC 1500 cellsµL
platelet count 100000µL
hemoglobin 90 gdL
5 Subjects who have at least a 12-week life expectancy at the Investigators discretion
6 Subjects who have Eastern Cooperative Oncology Group ECOGPerformance Status 0-1
Exclusion
1 Subjects who were treated with surgery radiotherapy chemotherapy or investigational therapy within 2 weeks note placement of biliary stent is allowed
2 Subjects who have uncontrolled CNS metastases patients who require steroids should be on a stable or decreasing dose for at least 2 weeks
3 Subjects who have any contraindications for 5-FU leucovorin or oxaliplatin
4 Subjects who have moderate or severe cardiovascular disease
Subjects who have myocardial infarction unstable angina pectoris New York Heart Association NYHA Class IIIIV congestive heart failure or uncontrolled hypertension within 6 months before screening
Subjects who have major abnormalities at the Investigators discretion based on electrocardiogram ECGand Doppler ECHO results at screening or within 14 days before screening
Subjects who have increase in brain natriuretic peptideBNP or increase in troponin over 99th percentile upper reference limit at Screening based on the normal range of relevant study center
Subjects who have risk factors for ascending aortic aneurysm such as genetic disorder and trauma and risk factors for aortic stenosis
Subjects who have a history of heart or aorta surgery
5 Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening
6 Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drugs
7 Subjects who have received prior treatment targeting the signaling pathway of TGF-β
8 Subjects who have a disease or condition that affects the mechanism of the investigational product or are currently using or planning to use
Drugs that are exclusively or primarily eliminated by cytochrome P-450 isozyme CYP including CYP1A2 CYP2B6 or CYP3A4
Drugs that are exclusively or primarily eliminated by UDP glucuronyltransferase UGT 1A1 UGT1A1
Drugs that are substrates for the drug transporter multidrug resistance protein 1 MDR1 have a narrow therapeutic window or are strong inhibitors of drug transporter MDR1
Drugs that are strong inhibitors or inducers of CYP2D6 or CYP3A4
9 Subjects who are unable to swallow tablets
10 Subjects who have a history of or are suspected of drug abuse
11 Female subjects of child-bearing potential who have a positive result on a pregnancy test at screening or are unable to agree to use an effective barrier method of birth control to avoid pregnancy during the study period eg sterilization intrauterine contraceptive device combination of oral contraception and barrier contraception combination of other hormone delivery systems and barrier contraception contraceptive cream combination of cream jelly or form and diaphragm or condom
12 Subjects in the opinion of the Investigator who are unsuitable to participate in the study
13 Subjects who were treated with other investigational products within 28 days before screening or within a period shorter than 5-timesthe half-life of the investigational product
Detailed Description:
None
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