Patients affected by metastatic pancreatic adenocarcinoma (PDAC). MedDRA version: 20.0 Level: PT Classification code 10052747 Term: Adenocarcinoma pancreas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: LEUKERAN - 2 MG COMPRESSE RIVESTITE CON FILM 25 COMPRESSE
Product Name: Leukeran
Product Code: [024790026]
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Clorambucile
CAS Num
Sponsors
OSPEDALE SAN RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically confirmed pancreatic adenocarcinoma 2) Age = 18 years 3) ECOG PS 0-2 4) Stage IV disease 5) Identified genetic aberrations that are associated with homologous recombination deficiency (HRD) a) Cohort A: Documented mutation in gBRCA1 or gBRCA2 that is predicted to be deleterious or suspected deleterious b) Cohort B: BRCA1 or BRCA2 mutations that are considered to be of uncertain/unknown significance (VUS) c) Cohort C: Patients with other identified genetic aberrations that are associated with HRD 6) adequate PFS during previous platinum-based chemotherapy for at least 4 months before progression 7) Screening laboratory values: Leukocytes > 3000/mmc Thrombocytes > 150000/mmc Hemoglobin > 10 g/dl Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Clinically significant cardiac disease including unstable angina, acute myocardial infarction within 6 months prior to screening, congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities 2) Active and uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy 3) Vaccination with vaccines called “live”, since this treatment causes a drop of immunity defenses and a serious infection could result fatal. 4) History of seizure, head trauma and treatment with anti-epileptogenic drugs 5) Hypersensitivity to chlorambucil or to any excipients, in particular lactose 6) BRCA-mutated advanced pancreatic cancer who did not undergo maintenance with olaparib after platinum-based chemotherapy 7) Mismatch repair (MMR)/high levels of microsatellite instability (MSI-H), or high levels of tumor mutational burden (TMB) pancreatic cancer who did not undergo immunotherapy with pembrolizumab monotherapy or any other anti-PD1 agent 8) Concomitant PARP inhibitors therapy 9) Life expectancy less than 3 months, in the opinion of the investigator 10) Other past or current malignancy. Subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma are eligible 11) Symptomatic duodenal stenosis 12) Any significant medical condition laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study 13) Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study 14) Any condition that confounds the ability to interpret data from the study 15) Any familiar, sociologic or geographic conditions that can potentially interfere with the adhesion to the protocol or to the follow-up 16) Pregnant or nursing. Adequate contraception is defined as oral hormonal birth control, intrauterine device, and male partner sterilization 17) Concurrent treatment with other experimental drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the proportion of patients who are progression-free (defined as progression according to RECIST 1.1 criteria, or death) at 6 months (PFS-6) from registration into the trial.;Secondary Objective: -Overall survival (OS), defined as time between the date of registration and the date of death for any cause or the date they were last known to be alive. -PFS, defined as the time between the date of registration and the date of documented radiological PD according to RECIST 1.1 criteria or death from any cause, whichever occurs first, or the date of last follow-up or last available tumor assessment if no further follow-up for disease progression is performed. -RECIST radiological response rate. -CA19-9 response rate. -Safety;Primary end point(s): Evaluate the proportion of patients who are progression-free at 6 months (PFS-6);Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS); The progression free survival (PFS); RECIST radiological response rate.; Ca19.9 response rate.; Safety;Timepoint(s) of evaluation of this end point: 3 years; 3 years; until drug unacceptable toxicity or medical decision.; until drug unacceptable toxicity or medical decision.; until drug unacceptable toxicity or medical decision. | — |
Countries
Italy
Contacts
Public ContactOncologia Medica
Ospedale San Raffaele
Outcome results
None listed