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Chemotherapy Agent

CPI-613 + FOLFIRINOX for Locally Advanced Pancreatic Cancer

Q: Is this research opportunity available to elderly individuals?

This clinical investigation is open to patients aged 18-80. There are 83 studies available for minors and 1193 research projects dedicated to seniors.

Q: What have clinical trials revealed about the efficacy of CPI 613?

CPI 613 is typically administered to patients with colorectal carcinoma. Additionally, it has also been considered a viable treatment for <a href="https://www.withpower.com/clinical-trials/ovarian-cancer">ovarian cancer</a>, <a href="https://www.withpower.com/clinical-trials/sarcoma">sarcoma</a> and metastatic colorectal carcinoma.

Q: Are there any restrictions to participating in this medical trial?

Candidates wishing to participate in this clinical trial must prove that they have malignant neoplasm of pancreas and fall within the age range of 18-80. The researchers are seeking 49 volunteers for their research.

Q: What is the ultimate goal of this research endeavor?

The primary endpoint of this trial, measured over a 4-week period from the outset of treatment, is Overall Survival. Secondary outcomes include Response rates per RECIST version 1.1 (complete response, partial response and stable disease), Surgical resection rate for those initially deemed borderline or non-resectable after receiving protocol treatments; and Resection margins with 95% confidence intervals estimated to measure the success rate of negative margin removal.

Q: Could you provide details regarding the current status of recruitment for this trial?

At this time, the clinical trial is not accepting participants. It was posted on December 7th 2018 and last updated on September 14th 2022. However, if you are seeking other studies, 697 trials for malignant neoplasm of pancreas and 558 studies for CPI 613 have openings in their enrolment process.

Q: What previous research has been done using CPI 613?

Presently, 558 trials are underway to investigate the effects of CPI 613. Out of these studies, 171 have progressed to Phase 3 and most clinical sites for this medication are located in Woolloongabba, Queensland with a total of 22492 locations running tests.

Q: What is the current caseload of this clinical experiment?

This research is no longer accepting participants. It was initially made public on December 7th 2018, and its most recent update occurred September 14th 2022. If you are looking for a different clinical trial, at present there are 697 trials actively enrolling individuals with malignant neoplasm of pancreas and 558 studies involving CPI613 that have open slots for interested parties.

Phase 1 & 2

Waitlist Available

Led By David Bajor, MD

Research Sponsored by Jeffrey Hardacre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must have locally advanced (including unresectable or borderline resectable) pancreatic cancer based on CT or MRI imaging as determined by the PI or Co-investigators

Eastern Cooperative Oncology Group (ECOG) Performance status being 01 within 1 week of planned start of therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years after completion of treatment

Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat pancreatic cancer that has not spread and is not able to be removed by surgery.

Who is the study for?

This trial is for adults with pancreatic cancer that can't be surgically removed. They should have a certain level of physical fitness (ECOG 0-1), good organ function, no serious infections recently, and an expected survival of at least 3 months. Women must not be pregnant and agree to contraception; men also need to use birth control if they're fertile.Check my eligibility

What is being tested?

The study tests CPI-613 in combination with FOLFIRINOX (a mix of drugs: 5-flurouracil, folinic acid, oxaliplatin, irinotecan) against localized pancreatic cancer that cannot be removed by surgery. The goal is to see if this combo is safe and works better than current treatments.See study design

What are the potential side effects?

Possible side effects include reactions from the drug infusion, fatigue, nausea or vomiting due to chemotherapy drugs like FOLFIRINOX components. There may also be blood cell count changes leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreatic cancer is advanced but hasn't spread far, as confirmed by scans.

Select...

I am very active or have minor symptoms that don't limit my daily activities.

Select...

My blood, liver, kidney functions are normal, and I am expected to live at least 3 more months.

Select...

I am using birth control and have a recent negative pregnancy test.

Select...

My cancer is confirmed as pancreatic adenocarcinoma through testing.

Select...

I am a man who can father children and will use birth control during the study, unless I'm infertile.

Select...

I haven't had a serious infection or been hospitalized for one in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years after completion of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years after completion of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years after completion of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

MTD of CPI-613 when given in combination with mFOLFIRINOX

Overall Survival

Secondary outcome measures

Complete pathologic response rates (CRp)

Median Progression free survival (PFS)

Median Time to progression (TTP)

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Standard Dose Cohort: CPI-613 + mFOLFIRINOXExperimental Treatment5 Interventions

Novel drug and mitochondrial inhibitor, CPI-613 in conjunction with standard-of-care FOLFRINOX. Consists of a Standard Dose Cohort and Dose escalation cohort using a standard 3 + 3 design starting at 750 mg/m^2 given at a rate of 4 ml/min ("dose level (DL) 2"). Participants receiving a dose of 1000mg/m^2 will be treated over 2 hours. In the absence of any DLT, the next DL will begin enrollment. If 1 DLT occurs, the DL will be expanded by 3 participants. If <33% of participants experience a DLT, the next DL will be opened and will proceed in similarly. Only 2 DLs are expected to be studied: 750 mg/m^2 and 1000 mg/m^2. Participants may be enrolled in this cohort after the accrual goal of the standard cohort is met but prior to the completion of treatment of all patients in the standard dose cohort Participants experiencing a DLT will be allowed to continue on the study at the standard DL of 500 mg or lower.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxaliplatin

2011

Completed Phase 4

~2560

Irinotecan

2017

Completed Phase 4

~2680

Folinic acid

2012

Completed Phase 3

~1290

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jeffrey HardacreLead Sponsor

David BajorLead Sponsor

1 Previous Clinical Trials

53 Total Patients Enrolled

David Bajor, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

3 Previous Clinical Trials

119 Total Patients Enrolled

Media Library

5-flurouracil (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03699319 — Phase 1 & 2

Pancreatic Cancer Research Study Groups: Standard Dose Cohort: CPI-613 + mFOLFIRINOX

Pancreatic Cancer Clinical Trial 2023: 5-flurouracil Highlights & Side Effects. Trial Name: NCT03699319 — Phase 1 & 2

5-flurouracil (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03699319 — Phase 1 & 2

Frequently Asked Questions

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

Is this research opportunity available to elderly individuals?

"This clinical investigation is open to patients aged 18-80. There are 83 studies available for minors and 1193 research projects dedicated to seniors."

Answered by AI

What have clinical trials revealed about the efficacy of CPI 613?

"CPI 613 is typically administered to patients with colorectal carcinoma. Additionally, it has also been considered a viable treatment for ovarian cancer, sarcoma and metastatic colorectal carcinoma."

Answered by AI

Are there any restrictions to participating in this medical trial?

"Candidates wishing to participate in this clinical trial must prove that they have malignant neoplasm of pancreas and fall within the age range of 18-80. The researchers are seeking 49 volunteers for their research."

Answered by AI

What is the ultimate goal of this research endeavor?

"The primary endpoint of this trial, measured over a 4-week period from the outset of treatment, is Overall Survival. Secondary outcomes include Response rates per RECIST version 1.1 (complete response, partial response and stable disease), Surgical resection rate for those initially deemed borderline or non-resectable after receiving protocol treatments; and Resection margins with 95% confidence intervals estimated to measure the success rate of negative margin removal."

Answered by AI

Could you provide details regarding the current status of recruitment for this trial?

"At this time, the clinical trial is not accepting participants. It was posted on December 7th 2018 and last updated on September 14th 2022. However, if you are seeking other studies, 697 trials for malignant neoplasm of pancreas and 558 studies for CPI 613 have openings in their enrolment process."

Answered by AI

What previous research has been done using CPI 613?

"Presently, 558 trials are underway to investigate the effects of CPI 613. Out of these studies, 171 have progressed to Phase 3 and most clinical sites for this medication are located in Woolloongabba, Queensland with a total of 22492 locations running tests."

Answered by AI

What is the current caseload of this clinical experiment?

"This research is no longer accepting participants. It was initially made public on December 7th 2018, and its most recent update occurred September 14th 2022. If you are looking for a different clinical trial, at present there are 697 trials actively enrolling individuals with malignant neoplasm of pancreas and 558 studies involving CPI613 that have open slots for interested parties."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer

David Bajor 2018. "CPI-613 in Combination With Modified FOLFIRINOX in Locally Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03699319.

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