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

NCT04258072 | Unknown Phase 1

• 1 other identifier: 2019-10-054
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Pancreas Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  up to 6 weeks

Study Arms (1)

open label,single arm

EXPERIMENTAL

Vactosertib\* 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

Drug: Vactosertib

Interventions

Vactosertib DRUG

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

Also known as: TEW-7197

open label,single arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

vactosertib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD,Principal Investigator

Model Details: * 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

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 6, 2020
• Study Start: April 19, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)