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Pancreas CancerPhase 1NCT04258072

Vactosertib With Nal-IRI/FL in Metastatic Pancreatic Ductal Adenocarcinoma.

A Phase 1 study testing Vactosertib in people with Pancreas Cancer, run by Samsung Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine recommended phase 2 dose and to evaluate the safety of vactosertib in combination with nal-IRI/FL in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first-line gemcitabine and nab-paclitaxel Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Pancreas Cancer
What is being tested?
Vactosertib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteSouth Korea
Study dates
19 Apr 2021to Mar 2023
Phase
Phase 1
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

  • Subjects who are males or females ≥ 19 years of age
  • Subjects who have the following history of first-line gemcitabine-based chemotherapy 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
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  • serum creatinine ≤ 1.5 x ULN or 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

Who cannot join

  • 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 nal-IRI
  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 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

    Recruiting

Other trials in South Korea

About this study

Official title: Phase 1b Study of Vactosertib (TEW-7197) in Combination With Nal-IRI／FL in Patients With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed First-Line Gemcitabine／Nab-Paclitaxel

To determine recommended phase 2 dose and to evaluate the safety of vactosertib in combination with nal-IRI/FL in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first-line gemcitabine and nab-paclitaxel

Read the detailed description
  • Number of patients : Total 24 patients (6-12 patients in phase 1 part and 12 patients in expansion cohort )
  • Treatment :
  • Vactosertib* 100-300 mg bid for 5 days
  • Liposomal Irinotecan (Onivyde) 70mg/m2 on D1
  • LV 200mg/m2 IV bolus on D1
  • 5-FU 2400mg/m2 CIV over 46 hours on D1
  • Vactosertib will be kindly provided by MedPacto.
  • Disease evaluation: Tumor assessment will be conducted at screening and before Day 1 of every third cycle starting with Cycle 4
  • Period : Approximately 24 months from the date of Institutional Review Board (IRB) approval
  • Primary endpoint : To determine recommended phase 2 dose and to evaluate the safety of vactosertib in combination with nal-IRI/FL in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have failed first-line gemcitabine and nab-paclitaxel
  • Secondary endpoint :
  • Progression-Free Survival (PFS) (RECIST 1.1 criteria)
  • Overall Survival (OS)
  • Objective Response Rate (ORR) (RECIST 1.1 criteria)
  • Disease Control Rate (DCR) (RECIST 1.1 criteria)
  • Exploratory endpoint
  • Pharmacokinetic assessment: before treatment, post treatment 1.5h, 4.5h, and 8hPharmacodynamic assessment: to evaluate changes in the amount of p-SMAD in PBMC.
  • Biomarker analysis in pre-treated and post-treated tumor samples
Conditions
Pancreas Cancer
Being tested
Vactosertib
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VactosertibDrug

    Also called TEW-7197

    Vactosertib: 50-mg white round film-coated tablets containing excipients (lactose monohydrate Fastflo 316, microcrystalline cellulose Avicel PH 102, crospovidone Kollidon CL-F, povidone Kollidon 30, magnesium stearate, opadry white) and active pharmaceutical ingredient (N-((4-([1,2,4]triazolo[1,5-a]pyridin-6-yl)-5-(6-methylpyridin-2-yl)-1H-imidazol-2-yl)methyl)-2-fluoroaniline), 10% (w/w) of total weight

Study groups in NCT04258072
Study groupRoleWhat they receive
open label,single armExperimentalVactosertib* 100-300 mg bid for 5 days + Liposomal Irinotecan (Onivyde) 70mg/m2 + LV 200mg/m2 IV bolus + 5-FU 2400mg/m2 CIV over 46 hours
Receives: Drug: Vactosertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (PFS)

    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.

  1. First posted6 Feb 2020
  2. Study start19 Apr 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
* Vactosertib\* 100-300 mg bid for 5 days * Liposomal Irinotecan (Onivyde) 70mg/m2 on D1 * LV 200mg/m2 IV bolus on D1 * 5-FU 2400mg/m2 CIV over 46 hours on D1
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04258072
Sponsor's protocol ID
2019-10-054
Status last verified
Jun 2022
First submitted
21 Jan 2020
Last updated
15 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vactosertib in people with Pancreas Cancer, run by Samsung Medical Center 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 13 inclusion and 22 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 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) (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?

On the ClinicalTrials.gov record for NCT04258072.

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.

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