Status:
TERMINATED
tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr
Lead Sponsor:
Luca Cardone
Collaborating Sponsors:
Anticancer Fund, Belgium
Azienda Ospedaliera Universitaria Integrata Verona
Conditions:
Pancreatic Adenocarcinoma Metastatic
Pancreatic Adenocarcinoma Recurrent
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study is designed to assess the therapeutic efficacy of decitabine repurposing against advanced, refractory, ductal adenocarcinoma (PDAC) with molecular transcriptional signatures indicating depen...
Detailed Description
TYPE OF STUDY: Phase II study, open label, multicentre, single arm, interventional, Non-randomized  TARGET POPULATION: Advanced (locally advanced or metastatic), pre-treated PDAC patients, progressin...
Eligibility Criteria
Inclusion
- Age ≥ 18 years;
- Histologically or cytologically proven, advanced, inoperable (metastatic or locally advanced), PDAC;
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;
- Life expectancy of at least 12 weeks;
- At least one and no more than two lines of systemic treatment for advanced disease;
- At least one metastatic lesion(s) and/or primary tumor amenable to pre-treatment biopsy;
- KRAS dependency, as assessed by molecular analysis of RNA isolated from a fresh tumor biopsy;
- Imaging-documented progressive disease (PD), according to modified RECIST 1.1 criteria;
- Imaging-documented measurable disease, according to modified RECIST 1.1 criteria;
- Adequate organ and marrow function;
- Postmenopausal status or evidence of non-childbearing status (negative urine or serum pregnancy test) for women of childbearing potential;
- Women of childbearing potential (defined as not post- menopausal for 12 months or no previous surgical sterilization) and fertile men must agree to use two highly effective forms of contraception while they are receiving
Exclusion
- Uncontrolled intercurrent illness(es);
- Pregnancy or lactation;
- Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;
- Major surgical intervention within 4 weeks prior to enrollment;
- Radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to signing the treatment ICF;
- Any previous treatment with DEC;
- Patients with second primary cancers, except for adequately treated non- melanoma skin cancer, curatively treated in-situ cancer of the cervix, stage 1 grade 1 endometrial carcinoma, or other solid tumours including lymphomas (without bone marrow involvement) treated with curative intent and with no evidence of active disease at \>1 year from the completion of curative treatment prior to study entry;
- Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia;
- Serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug;
- Serious psychiatric or medical conditions that could interfere with a valid informed consent.
Key Trial Info
Start Date :
January 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2024
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT05360264
Start Date
January 15 2022
End Date
October 10 2024
Last Update
March 24 2025
Active Locations (6)
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1
Irccs S. Raffaele - Milano
Milan, Italy
2
Istituto Nazionale Tumori Di Napoli Irccs Pascale
Napoli, Italy
3
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy
4
Istituti Fisioterapici Ospitalieri- Ifo - Istituto Regina Elena
Rome, Italy, 00015