Clinical trialNARecruiting
Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
- Outcome
- Ongoing
- Phase
- NA
- Status
- Recruiting
- Study type
- Interventional
- Start
- 1 July 2022
- Expected end
- 1 September 2027
- Enrollment
- 750 participants
- Sites
- 1
- Primary outcomes
- 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.
- Sponsor
- Other
- Results posted
- No
- Last update
- 31 March 2026
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Biological: Tumor samples (archival FFPE and optional de novo biopsy) and blood samples. Molecular screening
Arm public domain (ClinicalTrials.gov)
Metastatic/advanced PDAC Patients (experimental): Tumor samples
Primary outcome public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
Time from ICF signature to day 1 of next line of therapy. Time frame: At day 1.
Secondary outcome public domain (ClinicalTrials.gov)
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).
Secondary outcome public domain (ClinicalTrials.gov)
Progression-Free Survival (PFS). Time frame: Up to 12 months.
Secondary outcome public domain (ClinicalTrials.gov)
Best overall response (BoR). Time frame: Up to 12 months.
Secondary outcome public domain (ClinicalTrials.gov)
Overall survival (OS). Time frame: Up to 12 months.
Secondary outcome public domain (ClinicalTrials.gov)
Duration of response (DoR). Time frame: Up to 12 months.
Eligibility public domain (ClinicalTrials.gov)
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.
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 750 participants (estimated).