Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Metastatic/advanced PDAC Patients Tumor samples |
Biological: Tumor samples (archival FFPE) and blood samples
Molecular screening
|
Outcome Measures
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. [At the end of study (5 years)]
Secondary Outcome Measures
- Time from ICF signature to day 1 of next line of therapy [At day 1]
- Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated [At the end of study (5 years)]
- Progression-Free Survival (PFS) [Up to 12 months]
- Best overall response (BoR) [Up to 12 months]
- Overall survival (OS) [Up to 12 months]
- Duration of response (DoR) [Up to 12 months]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Léon Bérard | Lyon | France | 69373 |
Sponsors and Collaborators
- Centre Leon Berard
Investigators
- Principal Investigator: Philippe CASSIER, MD, PhD, Centre Leon Berard
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ET21-399 GENOPANC