Olaparib in PALB2 Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Modena
About this trial
This is a Phase II, non-randomized, multicenter, unblinded open-label study of Olaparib in monotherapy in participants with advanced (locally advanced/metastatic) PALB2-related pancreatic cancer that have progressed after at least one treatment for advanced disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Has a histologically or cytologically confirmed pancreatic adenocarcinoma
Has advanced (unresectable or metastatic) pancreatic cancer by American Joint Committee on Cancer 8th Edition
Has documented mutation in PALB2 gene (germline or somatic) that is predicted to be deleterious or suspected deleterious.
Has at least one lesion (measurable) that can be accurately assessed at baseline by CT scan (or MRI, if the subject is allergic to CT contrast media) and is suitable for repeated assessment according to RECIST Version 1.1 criteria.
Disqualifiers
Has a known additional malignancy that is progressing or requires active treatment. Other malignancy unless curatively treated with no evidence of disease for ≥5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma.
Has myelodysplastic syndrome/acute myeloid leukaemia or features suggestive of MDS/AML.
3. Patients with symptomatic uncontrolled brain metastases and/or carcinomatous meningitis. Subject with previously treated brain metastasis may participate proved they are stable (without evidence of progression by imaging for at leat four weeks prior to the first dose of trial treatment and any neurological symptoms have returned to baseline), no evidence of new or enlarging brain metastases. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
4. Has a documented weigh loss > 10% from baseline during screening and/or decline in ECOG PS to >1 between visit and within 73 hours prior to first dose of therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Olaparib 150 MG
DrugOlaparib should be dosed 2 x 150 mg tablets (300 BID)
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: OlaparbExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the ORR according to RECIST 1.1 following Olaparib administration
Objective response rate (ORR), defined as the percentage of patients with response of either Complete Response or Partial Response.
Time frame
2-3 yearsSecondary outcomes
1
To evaluate the PFS according to RECIST 1.1 following Olaparib administration
PFS, defined as the time from the date of the first dose until either disease progression or death due to any cause, whichever occurs first. .
Time frame
2-3 years2
To evaluate the Incidence of Treatment-Emergent Adverse Events of Olaparib
measument of Adverse events (AEs)
Time frame
2-3 years3
To evaluate the DOR according to RECIST 1.1 following Olaparib
DOR defined as the time from the date a response was first documented until either disease progression or death due to any cause, whichever occurs first.
Time frame
2-3 years4
To evaluate the DRC according to RECIST 1.1 following Olaparib
DCR defined as the percentage of patients with ORR and stable disease
Time frame
2-3 yearsSponsors and contacts
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Source ClinicalTrials.gov