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Olaparib in PALB2 Advanced Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Olaparib in PALB2 Advanced Pancreatic Cancer

A Phase II Multicentric Study of Olaparib in PALB2-related Advanced Pancreatic Cancer (PALBOLA)

NCT06078787•Azienda Ospedaliero-Universitaria di Modena

View on ClinicalTrials.gov

Summary

Detailed Description

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. After screening, 16 eligible participants with germline or somatic PALB2 mutations will be enrolled in this study. All participants will receive Olaparib 300 mg twice a daily (BID). Study intervention will continue until documented PD, unacceptable AEs, intercurrent illness that prevents further administration of the study intervention, investigator's decision to discontinue the participant, participant withdrawal of consent, pregnancy of the participant, administrative reasons requiring cessation of study intervention. After documented PD, each participant will be contacted by telephone every 12 weeks (+-14 days) to assess for survival status until withdrawal of consent to participate in the study, becoming lost to follow up, death or end of the study, whichever occurs first. During treatment, efficacy will be evaluated using ORR, PFS, DOC and DCR using RECIST 1.1 Efficacy will also be evaluated by assessing OS. Participants will be evaluated with radiographic imaging to assess response to intervention at regular intervals throughout the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Has a life expectancy ≥16 weeks.
•Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 3 days of the treatment initiation.
•Has received at least one systemic treatment for advanced disease (locally advanced or metastatic disease).
•Has adequate organ function as defined in Table 2; all screening laboratory tests should be performed within 10 days prior to initiation of study intervention.
•Is male or female, who is at least 18 years of age at the time of signing the informed consent.
•Male Participants Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
+15 more criteria

Exclusion Criteria

•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.
•Has an active infection requiring systemic therapy.
•Has a known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
•Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia. Patients previously treated with Oxaliplatinum who experienced a ≤ G2 neuropathy can be included after consultation with the study physician
•Patients considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent.
•Is unable to swallow orally administered medication or patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
•Is a immunocompromised patients, e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV).
+25 more criteria

Locations (1)

Aou Modena

Modena, Italy

Key Dates

Start Date

August 1, 2023

Primary Completion Date

August 1, 2025

Completion Date

August 1, 2026

Last Updated

May 6, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Pancreatic CancerMetastatic Pancreatic Cancer

Interventions

Olaparib 150 MG

DRUG

Contacts

LAURA CORTESI, MD

CONTACT

+390594224334 hbc@unimore.it

FEDERICA CAGGIA

CONTACT

0594223134 federica.caggia@unimore.it

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Olaparib in PALB2 Advanced Pancreatic Cancer

Inclusion Criteria

Exclusion Criteria

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