Clinical TrialID 1993
Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
NCT04862260
Pancreatic Ductal Adenocarcinoma|Pancreatic Cancer|Pancreas Cancer|Metastatic Cancer
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 1993
- Evidence Id
- 1993
- Core Evidence Id
- 1993
- Source Clinical Trial Id
- 1968
- Herb2 Clinical Trial Id
- HBCT001968
- Nct Id
- NCT04862260
- Title
- Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
- Status
- Active_Not_Recruiting
- Phase
- Early_Phase 1
- Study Result
- No
- Study Condition
- Pancreatic Ductal Adenocarcinoma|Pancreatic Cancer|Pancreas Cancer|Metastatic Cancer
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Cholesterol metabolism disruption
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 3
- Outcome Measure
- Safety as measured by the rate of adverse events, To determine causality and grading severity of each adverse event (AEs) using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., 2 years|Characterization of dose-limiting toxicities, To determine the dose at which no more than 1 out of 6 patients experience a drug related dose-limiting toxicity. To confirm that the combination of daily atorvastatin 40 mg, ezetimibe 10 mg twice daily and monthly evolocumab 420 mg meets the criterion to be the recommended phase II dose (RP2D)., 2 years
- Sponsor Collaborator
- CHU de Quebec-Universite Laval|Canadian Institutes of Health Research (CIHR)|Biovalorem
- Funded By
- OTHER
- Location
- CHUM, Montreal, Quebec, H2X 0A9, Canada|CHU de Québec-Université Laval, Quebec city, Quebec, G1R 2J6, Canada
- Other Id
- CHLOE pancreas
- Start Date
- 2021-10-04
- Primary Completion Date
- 2025-01-31
- Completion Date
- 2026-12-31
- First Posted
- 2021-04-27
- Results First Posted
- Last Update Posted
- 2024-05-22
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT04862260
- Title Cn
- Title En
- Cholesterol Disruption in Combination With the Standard of Care in Patients With Advanced Pancreatic Adenocarcinoma
- Bilingual Status
- semi_complete