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COHORT 2 (Devimistat, 5-FU, HCQ) for Pancreatic Cancer

Northwestern University, Chicago, IL
Pancreatic Cancer+33 More ConditionsFluorouracil - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a combo of drugs to better treat advanced solid tumors. It blocks energy production tumor cells need & may kill them.

Eligible Conditions
  • Stage IV Pancreatic Cancer
  • Metastatic Biliary Tract Carcinoma
  • Biliary Tract Carcinoma
  • Refractory Urothelial Carcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Refractory Lung Adenocarcinoma
  • Cancer
  • Pancreatic Cancer
  • Stage III Pancreatic Cancer
  • Cholangiocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Bladder Cancer
  • Pancreatic Cancer (Refractory)
  • Colorectal Cancer
  • Metastatic Pancreatic Endocrine Carcinoma
  • Stage II Pancreatic Cancer
  • Ovarian Cancer
  • Metastatic Urothelial Carcinoma of the Ureter
  • Stage IV Ovarian Cancer
  • Stage III Ovarian Cancer
  • Stage III Colorectal Cancer
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma
  • Refractory Gastroesophageal Junction Adenocarcinoma
  • Stage IV Colorectal Cancer
  • Stage IV Lung Cancer
  • Lung Cancer
  • Refractory Colorectal Cancer
  • Stage III Lung Cancer
  • Refractory Ovarian Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

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Elimusertib
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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first)

Month 24
Duration of response (DOR)
Month 24
Overall response rate (ORR)
Month 24
Overall survival (OS)
Month 24
Progression free survival (PFS)
Day 30
Incidence of adverse events

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

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Patients with metastatic or unresectable clear cell renal cell carcinoma
1
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

3 Treatment Groups

COHORT 2 (Devimistat, 5-FU, HCQ)
1 of 3
COHORT 3 (Devimistat, 5-FU, HCQ, Gemcitabine)
1 of 3
COHORT 1 (Devimistat, 5-FU, HCQ)
1 of 3

Experimental Treatment

94 Total Participants · 3 Treatment Groups

Primary Treatment: COHORT 2 (Devimistat, 5-FU, HCQ) · No Placebo Group · Phase 2

COHORT 2 (Devimistat, 5-FU, HCQ)Experimental Group · 6 Interventions: Fluorouracil, Hydroxychloroquine, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Devimistat · Intervention Types: Drug, Drug, Procedure, Procedure, Procedure, Drug
COHORT 3 (Devimistat, 5-FU, HCQ, Gemcitabine)Experimental Group · 7 Interventions: Fluorouracil, Gemcitabine Hydrochloride, Hydroxychloroquine, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Devimistat · Intervention Types: Drug, Drug, Drug, Procedure, Procedure, Procedure, Drug
COHORT 1 (Devimistat, 5-FU, HCQ)Experimental Group · 6 Interventions: Fluorouracil, Hydroxychloroquine, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Devimistat · Intervention Types: Drug, Drug, Procedure, Procedure, Procedure, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Gemcitabine Hydrochloride
2005
Completed Phase 3
~5410
Hydroxychloroquine
2017
Completed Phase 4
~5840
Biospecimen Collection
2004
Completed Phase 1
~810
Computed Tomography
2017
Completed Phase 2
~2710
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time from baseline to disease progression, initiates subsequent anti-cancer therapy, or 24 months (whichever occurs first)

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,504 Previous Clinical Trials
866,621 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,278 Previous Clinical Trials
41,234,736 Total Patients Enrolled
Devalingam MahalingamPrincipal InvestigatorNorthwestern University
1 Previous Clinical Trials
17 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with cancer that cannot be effectively treated with standard procedures or you cannot tolerate those treatments.
To be in cohort 2, you must have been diagnosed with pancreatic cancer.
You have already tried all available targeted therapies, including anti-PD-1/anti-PD-L1, if they were recommended for you.
References

Frequently Asked Questions

What deleterious effects may arise from the utilization of Devimistat, 5-FU, and HCQ (COHORT 1)?

"Due to the fact it is a Phase 2 trial, with some preliminary safety data but none in regards to efficacy, our team at Power have rated the security of COHORT 1 (Devimistat, 5-FU, HCQ) as an intermediate level 2." - Anonymous Online Contributor

Unverified Answer

Are participants being actively enrolled in this investigation?

"According to information from clinicaltrials.gov, this trial is no longer enrolling patients as of February 6th 2023. Since then, it has been superseded by over six thousand other studies that are actively seeking participants." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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