Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

Metastatic Pancreatic Cancer Clinical Trial

Official title:

A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05380414
• Other study ID #: ET21-399 GENOPANC
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: September 1, 2027

Study information

• Verified date: July 2023
• Source: Centre Leon Berard
• Contact: Philippe CASSIER, MD, PhD
• Phone: 0426556833
• Email: philippe.cassier[@]lyon.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• Tumor samples (archival FFPE) and blood samples
Molecular screening

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time from ICF signature to day 1 of next line of therapy		At day 1
Secondary	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)
Secondary	Progression-Free Survival (PFS)		Up to 12 months
Secondary	Best overall response (BoR)		Up to 12 months
Secondary	Overall survival (OS)		Up to 12 months
Secondary	Duration of response (DoR)		Up to 12 months