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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516466-11-00
Enrollment
16
Registered
2024-11-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic pancreatic neoplasm with pathogenetic (C5) or possibly pathogenetic (C4) mutation of PALB2 found at the somatic or germinal level.

Brief summary

Objective response rate (ORR), defined as the percentage of patients with response of either CR or PR.

Detailed description

Assessment of PFS (progression-free survival), DOR (duration of response), DCR (disease control rate), OS (overall survival), safety and tolerability of treatment. Furthermore, the quality of life will be assessed through the EORTC QLQ-C30 questionnaire.

Interventions

DRUGLynparza 100 mg film-coated tablets
DRUGLynparza 150 mg film-coated tablets

Sponsors

Azienda Ospedaliero Universitaria Di Modena
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Objective response rate (ORR), defined as the percentage of patients with response of either CR or PR.

Secondary

MeasureTime frame
Assessment of PFS (progression-free survival), DOR (duration of response), DCR (disease control rate), OS (overall survival), safety and tolerability of treatment. Furthermore, the quality of life will be assessed through the EORTC QLQ-C30 questionnaire.

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026