Advanced (locally advanced or metastatic), pre-treated PDAC patients, progressing after at least one and no more than two lines of systemic therapy, whose tumors express a KRAS-dependency signature. MedDRA version: 21.1 Level: LLT Classification code 10051971 Term: Pancreatic adenocarcinoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: DACOGEN - 50 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) - 20 ML - 1 FLACONCINO
Product Name: DECITABINA
Product Code: [JNS-30979754]
Pha
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 study treatment and for 3 months after last dose of study drug. Male subjects must agree to refrain from sperm donation during the study and for 30 days after the last dose of study drugs; 13. Ability to understand and willingness to sign an appropriate written informed consent form (ICF). Signed informed consent form must be obtained prior to initiation of study-related activities. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to provide proof-of-concept of DEC antitumor activity in dKRAS metastatic PDAC.;Secondary Objective: Secondary objectives of the trial are to assess the feasibility of a molecularly tailored approach in advanced, pre-treated PDAC, as well as to assess treatment safety and tolerability, clinical benefit, impact on quality of life, and survival outcomes.;Primary end point(s): Best Overall Response Rate (BOR) according to RECIST1.1.;Timepoint(s) of evaluation of this end point: BOR is not a time-dependent endpoint and it is calculated based on the best overall response, whenever it occurs during the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Disease-control rate (DCR); Toxicity rate according to NCI-CTC v5.0; Progression-Free Survival (PFS)/Overall Survival (OS);Timepoint(s) of evaluation of this end point: DCR is not a time-dependent endpoint and it is calculated based on the best overall response (BOR), whenever it occurs during the trial.; After each cycle; At the end of study | — |
Countries
Italy
Contacts
Public ContactCLINICAL TRIAL CENTER
ISTITUTI FISIOTERAPICI OSPITALIERI
Outcome results
None listed