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Chemotherapy

FOLFIRINOX + NIS793 for Pancreatic Cancer

Phase 1
Recruiting
Led By Colin D Weekes, MD, PHD
Research Sponsored by Colin D. Weekes, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Participants must have adequate organ and marrow function as defined below: Absolute neutrophil count ≥1,500/mcL, Platelets ≥100,000/mcL, Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) if no biliary stenting has been done OR 2.0 x ULN if patient is status post biliary stenting or two downward trending values, AST(SGOT)/ALT(SGPT) Safety Run-in Metastatic Disease: < 5 x institutional ULN. Locally advanced disease: ≤3 × institutional ULN, Creatinine ≤ institutional ULN OR Glomerular filtration rate (GFR) no lower than 60 mL/min/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 months after baseline
Awards & highlights

Study Summary

This trial is being done to see if NIS793 is safe and effective to use in combination with the standard of care treatment (FOLFIRINOX) for people with metastatic pancreas adenocarcinoma.

Who is the study for?
This trial is for adults over 18 with advanced pancreatic cancer who haven't had prior treatment for their condition. They must be in good enough health to participate, as shown by certain blood tests and organ function assessments. People with controlled hepatitis or HIV can join. Pregnant women can't participate unless they agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing the effectiveness of a new drug called NIS793 combined with FOLFIRINOX (a mix of chemotherapy drugs), chemoradiation, and surgery against metastatic pancreas adenocarcinoma. The goal is to see if this combination improves outcomes compared to current standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to chemotherapy such as nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, fatigue, and potential allergic reactions. Surgery and radiation may also cause specific complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had hepatitis C but am cured, or I'm being treated with no detectable virus.
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Your blood counts, liver function, and kidney function must be within a certain range to participate in the study.
Select...
I have pancreatic cancer that has spread and haven't been treated for it yet.
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My hepatitis B virus load is undetectable with treatment.
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I am 18 years old or older.
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I have advanced pancreatic cancer and haven't received treatment for it.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months after baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 months after baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
R0 Resection Rate
Safety Run In-Recommended Phase 2 dose (RP2D)
Secondary outcome measures
Disease-Free Survival (DFS)
Overall survival (OS)
Pathologic complete response (pCR)
+2 more

Side effects data

From 2013 Phase 3 trial • 688 Patients • NCT00424255
63%
Mucosal inflammation
52%
Nausea
48%
Rash
44%
Vomiting
42%
Diarrhoea
42%
Dry mouth
36%
Dysphagia
26%
Weight decreased
25%
Lymphopenia
24%
Leukopenia
22%
Anaemia
20%
Neutropenia
18%
Pyrexia
18%
Decreased appetite
17%
Constipation
17%
Asthenia
16%
Radiation skin injury
14%
Stomatitis
13%
Cough
13%
Oropharyngeal pain
13%
Blood creatinine increased
12%
Odynophagia
12%
Skin reaction
12%
Fatigue
12%
Hypokalaemia
9%
White blood cell count decreased
9%
Haemoglobin decreased
9%
Hyponatraemia
9%
Dysgeusia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Dyspepsia
8%
Creatinine renal clearance decreased
7%
Dysphonia
7%
Pruritus
7%
Productive cough
7%
Oral pain
7%
Thrombocytopenia
6%
Lymphocyte count decreased
6%
Headache
6%
Neck pain
5%
Oral candidiasis
5%
Insomnia
4%
Radiation mucositis
4%
Musculoskeletal pain
3%
Ejection fraction decreased
2%
Pneumonia
2%
Dehydration
1%
Hepatic enzyme increased
1%
Oesophageal stenosis
1%
Pharyngeal fistula
1%
Epistaxis
1%
Hyperkalaemia
1%
Acute respiratory failure
1%
Mouth haemorrhage
1%
Wound infection
1%
Febrile neutropenia
1%
General physical health deterioration
1%
Hyperuricaemia
1%
Malnutrition
1%
Hypocalcaemia
1%
Feeding disorder
1%
Sepsis
1%
Lung abscess
1%
Oral infection
1%
Blood uric acid increased
1%
Dyspnoea
1%
Pneumonia aspiration
1%
Tracheostomy malfunction
1%
Cerebral ischaemia
1%
Renal failure
1%
Renal impairment
1%
Hyperbilirubinaemia
1%
Depression
1%
Death
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lapatinib 1500 mg

Trial Design

3Treatment groups
Experimental Treatment
Group I: Safety Run-InExperimental Treatment2 Interventions
Following a 3 + 3 dose escalation design 6-18 participants will receive NIS793 and FOLFIRINOX on day 1 of each 14 day cycle for 3+ cycles until recommended phase 2 dose is determined.
Group II: FOLFIRINOX + NIS793Experimental Treatment10 Interventions
Participants will be randomly assigned to receive: FOLFIRINOX FOLFIRINOX + NIS793 on day 1 of each 14 day cycle for cycles 1-8 Cycles 9+: Chemoradiation (CRT) with NIS793, Surgery, NIS793
Group III: FOLFIRINOXExperimental Treatment9 Interventions
Participants will be randomly assigned to receive: FOLFIRINOX on day 1 of each 14 day cycle for cycles 1-8 Cycles 9+: Chemoradiation (CRT) and surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
FDA approved
Irinotecan
FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
NIS793
2017
Completed Phase 1
~120
Capecitabine
FDA approved
Chemoradiation
2006
Completed Phase 3
~990
Surgery
2000
Completed Phase 3
~2550
Fluorouracil
FDA approved
FOLFIRINOX
2013
Completed Phase 3
~790
Oxaliplatin
FDA approved

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,720,985 Total Patients Enrolled
Colin D. Weekes, M.D.Lead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Colin D Weekes, MD, PHDPrincipal InvestigatorMassachusetts General Hospital

Media Library

5-Fluorouracil (5-FU) (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05417386 — Phase 1
Pancreatic Cancer Research Study Groups: Safety Run-In, FOLFIRINOX, FOLFIRINOX + NIS793
Pancreatic Cancer Clinical Trial 2023: 5-Fluorouracil (5-FU) Highlights & Side Effects. Trial Name: NCT05417386 — Phase 1
5-Fluorouracil (5-FU) (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05417386 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What dangers may arise from the utilization of Chemoradiation?

"The safety of chemoradiation has been evaluated as a 1 on a scale from 1 to 3 due its Phase 1 status, which implies limited evidence for efficacy and security."

Answered by AI

How many individuals have voluntarily enrolled in this clinical experiment?

"Affirmative. Clinicaltrials.gov reflects that recruitment for this medical trial, initially announced on August 9th 2022, is still ongoing. 50 individuals are required across 1 site to fulfill the requirements of the study."

Answered by AI

Are there still opportunities to join this research endeavor?

"As attested by clinicaltrials.gov, this trial is actively seeking participants since its launch on August 9th 2022 and subsequent update on the 19th of that same month."

Answered by AI

What are the end goals of this clinical experiment?

"The primary outcome of this trial, monitored over a period spanning up to two months after baseline, is R0 Resection Rate. Secondary assessments include Progression-free Survival (PFS), which assesses objective progression or death due to any cause between the date of randomization/registration and last follow-up for living patients; Resection Rate - measuring the percentage of participants who underwent resection at their primary tumour location regardless of residuals; and Overall Survival (OS) - tracking mortality from registration/randomisation until death due to any cause with censoring occurring upon last patient follow-up if still alive. All these outcomes"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
FOLFIRINOX + NIS793 in Pancreatic Cancer
Colin D. Weekes, M.D. 2022. "FOLFIRINOX + NIS793 in Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05417386.
~13 spots leftby Dec 2024
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