Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

Not Applicable

Recruiting

• Conditions: Metastatic Pancreatic Cancer; Advanced Pancreatic Cancer
• Interventions: Biological: Tumor samples (archival FFPE) and blood samples

• Registration Number: NCT05380414
• Lead Sponsor: Centre Leon Berard

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-18
• Study Start: 2022-07-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-11
• Last Update Posted: 2023-07-12
• Primary Completion: 2027-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metastatic/advanced PDAC Patients	Tumor samples (archival FFPE) and blood samples	Tumor samples

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Duration of response (DoR)	Up to 12 months
Best overall response (BoR)	Up to 12 months
Progression-Free Survival (PFS)	Up to 12 months
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)
Overall survival (OS)	Up to 12 months

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, France