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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
Safety Run-in Cohort: Histologically confirmed metastatic pancreatic adenocarcinoma without prior therapy for pancreatic adenocarcinoma
Phase 1B Cohort: Histologically confirmed locally advanced disease (borderline resectable or locally advanced pancreatic adenocarcinoma) or poorly differentiated adenosquamous carcinoma includes both borderline resectable or locally advanced disease. Patients with localized pancreas adenocarcinoma cannot have received any prior therapy for borderline resectable or locally advanced pancreas adenocarcinoma
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 2 months after baseline
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Pancreatic Cancer Metastatic
- Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with advanced pancreatic cancer, and have not received any treatment for it before.
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You have confirmed advanced or poorly differentiated pancreatic cancer and have not received any treatment for it before.
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You are 18 years old or older.
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You are able to perform daily activities without needing much help.
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Your blood counts, liver function, and kidney function must be within a certain range to participate in the study.
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If you had hepatitis C in the past, you must have completed treatment and no longer have the virus. If you are currently being treated for hepatitis C, you can join the study if the virus is not detectable in your blood.
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You can join the study if recent brain scans show that treated brain tumors are not getting worse, or if the doctor believes that immediate treatment for new or growing brain tumors is not needed right now.
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You have had or currently have another type of cancer that won't affect the evaluation of the study treatment.
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To join this study, participants must have a certain level of health, class 2 B or better.
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If you have HIV, you can join the trial if you are taking medicine that works well and your virus levels have been very low for the past 6 months.
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If you have chronic hepatitis B, the virus in your blood must be undetectable while on treatment.
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You have a history of heart problems or symptoms, or have been treated with drugs that can harm the heart.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 months after baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 months after baseline
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 moreSide effects data
From 2013 Phase 3 trial • 688 Patients • NCT0042425563%
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%
Oropharyngeal pain
13%
Cough
13%
Blood creatinine increased
12%
Odynophagia
12%
Fatigue
12%
Hypokalaemia
12%
Skin reaction
9%
Alanine aminotransferase increased
9%
White blood cell count decreased
9%
Hyponatraemia
9%
Dysgeusia
9%
Aspartate aminotransferase increased
9%
Haemoglobin decreased
9%
Dyspepsia
8%
Creatinine renal clearance decreased
7%
Dysphonia
7%
Productive cough
7%
Oral pain
7%
Thrombocytopenia
7%
Pruritus
6%
Lymphocyte count decreased
6%
Headache
6%
Neck pain
5%
Insomnia
5%
Oral candidiasis
4%
Radiation mucositis
4%
Musculoskeletal pain
3%
Ejection fraction decreased
2%
Pneumonia
2%
Dehydration
1%
Hyperkalaemia
1%
Acute respiratory failure
1%
Pharyngeal fistula
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%
Hepatic enzyme increased
1%
Blood uric acid increased
1%
Dyspnoea
1%
Pneumonia aspiration
1%
Epistaxis
1%
Tracheostomy malfunction
1%
Cerebral ischaemia
1%
Renal failure
1%
Renal impairment
1%
Hyperbilirubinaemia
1%
Depression
1%
Death
1%
Oesophageal stenosis
1%
Left ventricular dysfunction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lapatinib 1500 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Surgery
1999
Completed Phase 3
~2050
Capecitabine
2002
Completed Phase 3
~3230
FOLFIRINOX
2013
Completed Phase 3
~790
Oxaliplatin
2011
Completed Phase 4
~1990
Leucovorin
2005
Completed Phase 4
~5730
Irinotecan
2017
Completed Phase 4
~2680
5-Fluorouracil (5-FU)
2003
Completed Phase 3
~5560
NIS793
2017
Completed Phase 1
~120
Chemoradiation
2006
Completed Phase 3
~990
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Colin D. Weekes, M.D.Lead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
NovartisIndustry Sponsor
1,601 Previous Clinical Trials
2,708,919 Total Patients Enrolled
Colin D Weekes, MD, PHDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have confirmed advanced or poorly differentiated pancreatic cancer and have not received any treatment for it before.You are 18 years old or older.You are able to perform daily activities without needing much help.Your blood counts, liver function, and kidney function must be within a certain range to participate in the study.You have received any previous treatments for metastatic pancreas adenocarcinoma, such as chemotherapy, radiation therapy, immunotherapy, or other experimental therapies.If you had hepatitis C in the past, you must have completed treatment and no longer have the virus. If you are currently being treated for hepatitis C, you can join the study if the virus is not detectable in your blood.You can join the study if recent brain scans show that treated brain tumors are not getting worse, or if the doctor believes that immediate treatment for new or growing brain tumors is not needed right now.To join this study, participants must have a certain level of health, class 2 B or better.If you have HIV, you can join the trial if you are taking medicine that works well and your virus levels have been very low for the past 6 months.You have a history of frequent or severe bleeding, or have had a major bleeding event in the month before starting treatment.You are taking cimetidine, which can affect how your body processes 5FU. If needed, you can switch to a different medication that does not have this effect.You have a heart condition that requires medication to control irregular heartbeats, or a specific type of heart block caused by 5FU treatment.You have had a strong allergic reaction to a specific type of medication called a monoclonal antibody in the past.You have a known history of UGT1A1 gene polymorphism.You have been diagnosed with advanced pancreatic cancer, and have not received any treatment for it before.You have not received any previous chemotherapy, radiation therapy, immunotherapy, targeted therapy, or experimental treatment for your pancreatic tumor.You have certain types of cancers with specific genetic characteristics.You have not fully recovered from side effects of previous cancer treatments, except for hair loss.You cannot join the study if you currently need steroids for uncontrolled brain metastases. However, you may be eligible if you had radiation treatment more than 4 weeks ago and follow-up tests show that the condition is under control.You have had allergic reactions to drugs similar to NIS793, 5-fluorouracil, irinotecan, or oxaliplatin that cannot be managed with the hospital's allergy treatment plan.You have a blood clotting problem that is not being controlled. You cannot be taking full doses of warfarin (coumadin), but you can take other specific blood thinners for treating deep vein blood clots.You have had a live vaccine within 30 days before starting the study, except for certain types of flu shots and non-live COVID vaccines.You have had or currently have another type of cancer that won't affect the evaluation of the study treatment.If you have chronic hepatitis B, the virus in your blood must be undetectable while on treatment.You have a history of heart problems or symptoms, or have been treated with drugs that can harm the heart.
Research Study Groups:
This trial has the following groups:- Group 1: Safety Run-In
- Group 2: FOLFIRINOX
- Group 3: FOLFIRINOX + NIS793
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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