NCT03986294

Brief Summary

To determine the optimal second line treatment strategy in patients with metastatic pancreatic cancer who underwent a therapy with gemcitabine.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 14, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 15, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

February 11, 2019

Last Update Submit

January 14, 2021

Conditions

Metastatic Pancreatic Cancer

Keywords

Liposomal irinotecanS1Pancreatic cancerSecond line

Outcome Measures

Primary Outcomes (3)

  • DLT of Nal-IRI with S1

    Dose limiting toxicity (DLT) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer

    36 months

  • MTD of Nal-IRI with S1

    Maximum tolerated dose (MTD) of nal-IRI when co-administered with fixed dose S1 in patients with metastatic pancreatic cancer

    36 months

  • Progression free survival of NaI-IRI with S1

    Determination of the efficacy between the treatment arms in terms of progression free survival.

    36 months

Secondary Outcomes (4)

  • Overall survival

    36 months

  • Response rate according to RECIST 1.1

    36 months

  • Adverse events according NCI CTC version 4.0

    36 months

  • Quality of life QoL (QLQ-C30)

    36 months

Other Outcomes (3)

  • stromal markers

    36 months

  • Imaging (MRI)

    36 months

  • ctDNA

    36 months

Study Arms (2)

S1 and liposomal irinotecan

EXPERIMENTAL

S-1 will be given for 14 consecutive days, twice daily, followed by 2 weeks rest. Nal-IRI will be administered as an iv infusion on day 1 and 15. Treatment will be repeated every 4 wks.

Drug: S1 + Nal-IRIDrug: Nal-IRI+Leucovorin+5-FU

Liposomal irinotecan, Leucovorin and 5-fluoracil

EXPERIMENTAL

Nal-IRI 80 mg/m2 administered first, followed by LV 400 mg/m2, followed by 5-FU 2400 mg/m2 as an IV infusion over 46-hrs on days 1-3. Each cycle consists of 14 days. Treatment will be repeated every 2 wks.

Drug: Nal-IRI+Leucovorin+5-FU

Interventions

S1 + Nal-IRIDRUG

S-1 will be given for 14 consecutive days, twice daily, followed by 2 weeks rest. Nal-IRI will be administered as an intravenous infusion on day 1 and 15. Courses of treatment will be repeated every 4 weeks.

S1 and liposomal irinotecan
Nal-IRI+Leucovorin+5-FUDRUG

Nal-IRI 80 mg/m2 will be administered first, followed by LV 400 mg/m2, followed by 5-FU 2400 mg/m2 as an IV infusion over 46-hours on days 1-3. Each cycle consists of 14 days. Courses of treatment will be repeated every 2 weeks.

Liposomal irinotecan, Leucovorin and 5-fluoracilS1 and liposomal irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to understand and provide written informed consent
  • ≥ 18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of pancreas
  • Documented metastatic disease, according to RECIST 1.1.
  • Previously treated with gemcitabine or gemcitabine containing therapy, or progression within 6 months of adjuvant gemcitabine based treatment
  • Adequate hepatic, renal and hematological function

You may not qualify if:

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • Serum total bilirubin ≥1.5 x ULN (biliary drainage is allowed for biliary obstruction)
  • Severe renal impairment (CLcr ≤ 30 ml/min)
  • Inadequate bone marrow reserves as evidenced by:
  • ANC ≤ 1,5 x 10 9 /L; or
  • Platelet count ≤ 100 x 10 9 /L;
  • WHO/PS 0-1
  • Any clinically significant disorder impacting the risk-benefit balance negatively per physician's judgment
  • Any clinically significant gastrointestinal disorder, including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea \> grade 1
  • Severe arterial thromboembolic events (myocardial infarction, unstable angina pectoris, stroke) in last 6 months
  • NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings
  • Active infection or an unexplained fever \>38.5°C (excluding tumor fever), which in the physician's opinion might compromise the patient's health
  • Current use or any use in last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
  • Known hypersensitivity to any of the components of liposomal irinotecan (Nal-IRI) other liposomal irinotecan formulations, irinotecan, fluoropyrimidines, or leucovorin.
  • Hypersensitivity to any of the active substances (tegafur, gimeracil, and oteracil)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center, Medical Oncology

Amsterdam, 1100 DD, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination)irinotecan sucrosofate

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • J W Wilmink, MD, PhD

    Ademic Medical Center Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

J W Wilmink, MD, PhD

CONTACT

31 20 5665955j.w.wilmink@amsterdamumc.nl

E. N. Pijnappel, M.D.

CONTACT

31 20 5665955e.n.pijnappel@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 11, 2019

First Posted

June 14, 2019

Study Start

December 1, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)