Back to resultsProfiling Program of Advanced/Metastatic Pancreatic Cancer Patients
Primary Purpose
Metastatic Pancreatic Cancer, Advanced Pancreatic Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tumor samples (archival FFPE) and blood samples
Sponsored by
About this trial
This is an interventional screening trial for Metastatic Pancreatic Cancer focused on measuring Molecular screening, Genomic profiles, Transcriptomic profiles
Eligibility Criteria
Inclusion Criteria:
- Male or female patient > 18 years
- metastatic or advanced PDAC
- Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
- Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
- Life expectancy > 3 months
- PS score 0 or 1.
Exclusion Criteria:
- Curative therapy available
- Any condition contraindicated with blood sampling procedures required by the protocol.
- Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
- Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
Sites / Locations
- Centre Léon BérardRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Metastatic/advanced PDAC Patients
Arm Description
Tumor samples
Outcomes
Primary Outcome Measures
Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
Secondary Outcome Measures
Time from ICF signature to day 1 of next line of therapy
Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated
Progression-Free Survival (PFS)
Best overall response (BoR)
Overall survival (OS)
Duration of response (DoR)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05380414
Brief Title
Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
Official Title
A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
September 1, 2027 (Anticipated)
Study Completion Date
September 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer, Advanced Pancreatic Cancer
Keywords
Molecular screening, Genomic profiles, Transcriptomic profiles
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metastatic/advanced PDAC Patients
Arm Type
Experimental
Arm Description
Tumor samples
Intervention Type
Biological
Intervention Name(s)
Tumor samples (archival FFPE) and blood samples
Intervention Description
Molecular screening
Primary Outcome Measure Information:
Title
Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
Time Frame
At the end of study (5 years)
Secondary Outcome Measure Information:
Title
Time from ICF signature to day 1 of next line of therapy
Time Frame
At day 1
Title
Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated
Time Frame
At the end of study (5 years)
Title
Progression-Free Survival (PFS)
Time Frame
Up to 12 months
Title
Best overall response (BoR)
Time Frame
Up to 12 months
Title
Overall survival (OS)
Time Frame
Up to 12 months
Title
Duration of response (DoR)
Time Frame
Up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patient > 18 years
metastatic or advanced PDAC
Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
Life expectancy > 3 months
PS score 0 or 1.
Exclusion Criteria:
Curative therapy available
Any condition contraindicated with blood sampling procedures required by the protocol.
Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe CASSIER, MD, PhD
Phone
0426556833
Email
philippe.cassier@lyon.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe CASSIER, MD, PhD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe CASSIER, MD, PhD
Phone
0426556835
Email
philippe.cassier@lyon.unicancer.fr
12. IPD Sharing Statement
Learn more about this trial
Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
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