EW THERAPEUTIC INDICATION OF DECITABINE FOR THE TREATMENT OF ADVANCED, THERAPY-RESISTANT PANCREAS TUMORS WITH A SPECIFIC MOLECULAR PROFILE
- Conditions
- 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: 21.1Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2021-002632-23-IT
- Lead Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 17
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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