Safety Run-In for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital Cancer Center, Boston, MA
Adenocarcinoma+4 More
FOLFIRINOX - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This research is being done to evaluate the safety and effectiveness of the drug NIS793 in combination with the standard of care treatment FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin), chemoradiation and surgery for people with metastatic pancreas adenocarcinoma. The drugs involved in this study are: NIS793 FOLFIRINOX (consists of the drugs 5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan, and Leucovorin) Other interventions include chemoradiation surgery.

Eligible Conditions

  • Adenocarcinoma
  • Pancreatic Adenocarcinoma Metastatic
  • Pancreatic Metastatic Cancer
  • Malignant Neoplasm of Pancreas

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Adenocarcinoma

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 2 months after baseline

Month 2
Safety Run In-Recommended Phase 2 dose (RP2D)
Month 8
R0 Resection Rate
Year 6
Disease-Free Survival (DFS)
Overall survival (OS)
Progression-free survival (PFS)
Month 8
Pathologic complete response (pCR)
Resection rate

Trial Safety

Safety Progress

1 of 3

Other trials for Adenocarcinoma

Trial Design

3 Treatment Groups

Safety Run-In
1 of 3
FOLFIRINOX
1 of 3
FOLFIRINOX + NIS793
1 of 3
Experimental Treatment

50 Total Participants · 3 Treatment Groups

Primary Treatment: Safety Run-In · No Placebo Group · Phase 1

Safety Run-InExperimental Group · 2 Interventions: FOLFIRINOX, NIS793 · Intervention Types: Drug, Drug
FOLFIRINOXExperimental Group · 9 Interventions: FOLFIRINOX, Surgery, Oxaliplatin, Leucovorin, Irinotecan, 5-Fluorouracil (5-FU), Chemoradiation, Capecitabine, Radiation Therapy · Intervention Types: Drug, Procedure, Drug, Drug, Drug, Drug, Radiation, Drug, Radiation
FOLFIRINOX + NIS793Experimental Group · 10 Interventions: FOLFIRINOX, Surgery, Oxaliplatin, Leucovorin, Irinotecan, 5-Fluorouracil (5-FU), NIS793, Chemoradiation, Capecitabine, Radiation Therapy · Intervention Types: Drug, Procedure, Drug, Drug, Drug, Drug, Drug, Radiation, Drug, Radiation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRINOX
2013
Completed Phase 3
~760
Surgery
1999
Completed Phase 3
~2060
Oxaliplatin
2003
Completed Phase 4
~4430
Leucovorin
2014
Completed Phase 4
~5100
Irinotecan
2010
Completed Phase 4
~4150
5-Fluorouracil (5-FU)
2003
Completed Phase 3
~5560
NIS793
2017
Completed Phase 1
~120
Chemoradiation
2006
Completed Phase 3
~970
Capecitabine
2002
Completed Phase 3
~3010
Radiation Therapy
2005
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 months after baseline
Closest Location: Massachusetts General Hospital Cancer Center · Boston, MA
Photo of Boston  1Photo of Boston  2Photo of Boston  3
2006First Recorded Clinical Trial
22 TrialsResearching Adenocarcinoma
217 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Total bilirubin > 2.0 x ULN if patient is status post biliary stenting or two downward trending values.
You have a performance status of 0, 1, 2, or 3.
You have a platelet count of at least 100,000/mcL.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.