EUCTR2021-002632-23-IT
Active, not recruiting
Phase 1
A proof-of-concept, biomarker-driven, phase-II clinical trial to explore the activity of decitabine repurposing against advanced, refractory, KRAS-dependent pancreatic ductal adenocarcinoma (PDAC): The ORIENTATE (tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr) trial. - ORIENTATE
ISTITUTI FISIOTERAPICI OSPITALIERI0 sites17 target enrollmentSeptember 7, 2021
ConditionsAdvanced (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]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- 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.
- Sponsor
- ISTITUTI FISIOTERAPICI OSPITALIERI
- Enrollment
- 17
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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;
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;
Outcomes
Primary Outcomes
Not specified
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