tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr (NCT05360264) | Clinical Trial Compass
TerminatedPhase 2
tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr
Stopped: Unexpected toxicity events were documented during interim safety evaluations of the investigational drug.
Italy7 participantsStarted 2022-01-15
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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;
Exclusion criteria
✕. 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;
What they're measuring
1
Best Overall Respone (BOR) according to RECIST1.1
Timeframe: From registration to date of documented best response, assessed up to 24 months
✕. 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;