tailOred dRug repurposIng of dEcitabine in KRAS-dependeNt refracTory pAncreaTic cancEr
Key facts
- Who runs it
- Luca Cardone
- Where
- Italy6 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 7 people enrolled
- Started
- 15 Jan 2022
- Ended
- 10 Oct 2024
- Type of study
- Interventional
- Treatments tested
- Decitabine 50 MG [Dacogen]
- Record updated
- 24 March 2025
- Why it stopped
- Unexpected toxicity events were documented during interim safety evaluations of the investigational drug.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
- Imaging-documented measurable disease, according to modified RECIST 1.1 criteria
- Adequate organ and marrow function
- Postmenopausal status or evidence of non-childbearing status (negative urine or serum pregnancy test) for women of childbearing potential
- 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
Who cannot take part
- 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
- Any previous treatment with DEC
- 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
- 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
- Uncontrolled intercurrent illness(es)
- Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Persistent toxicities (≥CTCAE grade 2) caused by previous cancer therapy, excluding alopecia
- Serious psychiatric or medical conditions that could interfere with a valid informed consent
- Pregnancy or lactation
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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
The group in the trial
- Experimental groupTreatment being tested
A fresh, mandatory, tumor biopsy will be performed at baseline to assess KRAS mutational status and functional dependency and determine the patient's eligibility for the trial. KRAS dependency will be assessed based on computational score and inferred by a transcriptional signature of tumor cells. Transcriptomic data will be generated by using RNAseq data. Sample RNA processing and generation of the gene expression profile will be guaranteed within a maximum of 10 working days from the biopsy. Patients with high L-, S- or both L/S- scores of KRAS-dependency will receive DACOGEN. DACOGEN will be administered i.v. over 1 hour, at the dose of 10 mg/m2/d, daily on days 1-5 and 8-12 of each 4-wk cycle. Patients will continue to receive study treatment until objective radiological disease progression per modified RECIST 1.1, as assessed by the investigator, unacceptable toxicity, physician's decision, patient's refusal, or until they meet any other discontinuation criteria.
Treatment: Decitabine 50 MG [Dacogen]
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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 Trial
- Record updated
- 24 March 2025