Metastatic Pancreatic CancerPhase 1/2MP-PDAC-01NCT03666832
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
A Phase 1/2 study testing TEW-7197 in people with Metastatic Pancreatic Cancer, run by Joon Oh Park at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- TEW-7197
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jun 2019to 30 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 ≤ 1.5 x ULN (upper limit of normal)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
- serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault)
- partial thromboplastin time (aPTT) ≤ 1.5 x ULN
- absolute neutrophil count (ANC) ≥ 1,500 cells/µL
- platelet count ≥ 100,000/µL
- hemoglobin ≥ 9.0 g/dL 5) Subjects who have at least a 12-week life expectancy at the Investigator's discretion 6) Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1
Who cannot join
- 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 III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening
- Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening
- Subjects who have increase in brain natriuretic peptide(BNP) 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 drug(s) 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:
Show all 10Show fewer
- 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 (e.g., 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Joon Oh Park, M.D., Ph.D, 82 2 3410 3459, oncopark@skku.edu
yoon Jeong Ahn, 221487395 ext. 82
About this study
- Inclusion
- Subjects who are males or females ≥ 19 years of age
- Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma
- Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial
- Subjects who have the following laboratory test values:
Read more
- bilirubin ≤ 1.5 x ULN (upper limit of normal)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
- serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault)
- partial thromboplastin time (aPTT) ≤ 1.5 x ULN
- absolute neutrophil count (ANC) ≥ 1,500 cells/µL
- platelet count ≥ 100,000/µL
- hemoglobin ≥ 9.0 g/dL
- Subjects who have at least a 12-week life expectancy at the Investigator's discretion
- Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1
- Exclusion
- Subjects who were treated with surgery, radiotherapy, chemotherapy or investigational therapy within 2 weeks (note: placement of biliary stent is allowed)
- Subjects who have uncontrolled CNS metastases (patients who require steroids should be on a stable or decreasing dose for at least 2 weeks)
- Subjects who have any contraindications for 5-FU, leucovorin, or oxaliplatin
- Subjects who have moderate or severe cardiovascular disease
- Subjects who have myocardial infarction, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening
- Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening
- Subjects who have increase in brain natriuretic peptide(BNP) 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
- Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening
- Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drug(s)
- Subjects who have received prior treatment targeting the signaling pathway of TGF-β
- 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
- Subjects who are unable to swallow tablets
- Subjects who have a history of or are suspected of drug abuse
- 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 (e.g., 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)
- Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study
- 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
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- TEW-7197
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEW-7197Drug
Also called TEW-7197, FOLFOX
TEW-7197 1cycle 14days
-intake 5days, rest 2days
| Study group | Role | What they receive |
|---|---|---|
| Arm1 | Experimental | TEW-7197 100mg will be administered orally once a day 5days and rest 2days. Study treatment will be continued until objective disease progression. Receives: Drug: TEW-7197 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregression free survival
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
17 Jun 201930 Dec 2023
- First posted12 Sep 2018
- Study start17 Jun 2019
- Primary completionDec 2022 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joon Oh Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joon Oh Park, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666832
- Sponsor's protocol ID
- 2017-10-150
- Acronym
- MP-PDAC-01
- Status last verified
- Jun 2022
- First submitted
- 10 Sep 2018
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03666832
- Acronym / sponsor ID
- MP-PDAC-01 / 2017-10-150
- Conditions
- Metastatic Pancreatic Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Joon Oh ParkUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Inclusion
- Subjects who are males or females ≥ 19 years of age
- Subjects who have the following history of first-line gemcitabine and nab-paclitaxel among patients with cytologically or histologically proven metastatic pancreatic ductal adenocarcinoma
- Subjects who can give written informed consent for participation in this trial after receiving explanations of this trial
- Subjects who have the following laboratory test values:
- bilirubin ≤ 1.5 x ULN (upper limit of normal)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
- serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault)
- partial thromboplastin time (aPTT) ≤ 1.5 x ULN
- absolute neutrophil count (ANC) ≥ 1,500 cells/µL
- platelet count ≥ 100,000/µL
- hemoglobin ≥ 9.0 g/dL
- Subjects who have at least a 12-week life expectancy at the Investigator's discretion
- Subjects who have Eastern Cooperative Oncology Group (ECOG)Performance Status 0-1
- Exclusion
- Subjects who were treated with surgery, radiotherapy, chemotherapy or investigational therapy within 2 weeks (note: placement of biliary stent is allowed)
- Subjects who have uncontrolled CNS metastases (patients who require steroids should be on a stable or decreasing dose for at least 2 weeks)
- Subjects who have any contraindications for 5-FU, leucovorin, or oxaliplatin
- Subjects who have moderate or severe cardiovascular disease
- Subjects who have myocardial infarction, unstable angina pectoris, New York Heart Association (NYHA) Class III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening
- Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening
- Subjects who have increase in brain natriuretic peptide(BNP) 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
- Subjects who have clinically significant gastrointestinal bleeding within 4 weeks before screening
- Subjects who have a known history or suspected hypersensitivity to any excipients of the investigational product or combination drug(s)
- Subjects who have received prior treatment targeting the signaling pathway of TGF-β
- 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
- Subjects who are unable to swallow tablets
- Subjects who have a history of or are suspected of drug abuse
- 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 (e.g., 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)
- Subjects, in the opinion of the Investigator, who are unsuitable to participate in the study
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm1 | Experimental | Drug: TEW-7197TEW-7197 100mg will be administered orally once a day 5days and rest 2days. Study treatment will be continued until objective disease progression. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ≤ 1.5 x ULN (upper limit of normal)
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5 x ULN
- serum creatinine ≤ 1.5 x ULNor estimated creatinine clearance ≥ 40 mL/min (Cockcroft-Gault)
- partial thromboplastin time (aPTT) ≤ 1.5 x ULN
Key exclusion criteria (10 listed)
- 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 III/IV congestive heart failure, or uncontrolled hypertension within 6 months before screening
- Subjects who have major abnormalities at the Investigator's discretion based on electrocardiogram (ECG)and Doppler ECHO results at screening or within 14 days before screening
- Subjects who have increase in brain natriuretic peptide(BNP) 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEW-7197Also: TEW-7197, FOLFOXTEW-7197 1cycle 14days -intake 5days, rest 2days | Drug | Arm1 |
Primary outcome
pregression free survival
Time frame: up to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
Related trials for Metastatic Pancreatic Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Active, not recruitingPhase 2
Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer
Pancreatic Cancer
Not yet recruitingPhase 1
A Phase 1 Study of MC001 in Patients With Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Other Folate Receptor Alpha (FRα)-Expressing Solid Tumors
Pancreatic Ductal Adenocarcinoma (PDAC), Advanced Solid Tumor Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TEW-7197 in people with Metastatic Pancreatic Cancer, run by Joon Oh Park at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact joonoh park, Ph MD (82-2-2148-7394, oncopark66@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregression free survival (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.