tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to assess the therapeutic efficacy of decitabine repurposing against advanced, refractory, ductal adenocarcinoma (PDAC) with molecular transcriptional signatures indicating dependency on the KRAS oncogene

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luca Cardone
• Collaborators: Anticancer Fund, Belgium; Azienda Ospedaliera Universitaria Integrata Verona; Catholic University of the Sacred Heart; Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale; San Raffaele University Hospital, Italy; University of Pisa
• Treatments: Decitabine

Criteria

Inclusion Criteria:

1. Age ≥ 18 years;

2. Histologically or cytologically proven, advanced, inoperable (metastatic or locally advanced), PDAC;

3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2;

4. Life expectancy of at least 12 weeks;

5. At least one and no more than two lines of systemic treatment for advanced disease;

6. At least one metastatic lesion(s) and/or primary tumor amenable to pre-treatment biopsy;

7. KRAS dependency, as assessed by molecular analysis of RNA isolated from a fresh tumor biopsy;

8. Imaging-documented progressive disease (PD), according to modified RECIST 1.1 criteria;

9. Imaging-documented measurable disease, according to modified RECIST 1.1 criteria;

10. Adequate organ and marrow function;

11. Postmenopausal status or evidence of non-childbearing status (negative urine or serum pregnancy test) for women of childbearing potential;

12. 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 Criteria:

1. Uncontrolled intercurrent illness(es);

2. Pregnancy or lactation;

3. Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy;

4. Major surgical intervention within 4 weeks prior to enrollment;

5. Radiotherapy, surgery, chemotherapy, or an investigational therapy within 2 weeks prior to signing the treatment ICF;

6. Any previous treatment with DEC;

7. 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;

8. Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia;

9. 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;

10. Serious psychiatric or medical conditions that could interfere with a valid informed consent.