Actively Recruiting
Olaparib in PALB2 Advanced Pancreatic Cancer
Led by Azienda Ospedaliero-Universitaria di Modena · Updated on 2024-05-06
16
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Olaparib in PALB2 Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed pancreatic adenocarcinoma
- Advanced (unresectable or metastatic) pancreatic cancer by AJCC 8th Edition
- Documented deleterious or suspected deleterious PALB2 gene mutation (germline or somatic)
- At least one measurable lesion suitable for repeated assessment by CT or MRI
- Life expectancy of at least 16 weeks
- ECOG performance status of 0 or 1 within 3 days before treatment
- Received at least one systemic treatment for advanced disease
- Adequate organ function based on screening labs within 10 days prior to treatment
- Male or female, at least 18 years old at informed consent
- Males agree to use contraception during treatment and for 3 months after last dose
- Females must not be pregnant or breastfeeding and agree to contraception if of childbearing potential
- Provided written informed consent for the study
You will not qualify if you...
- Known additional progressing malignancy or requiring active treatment, except certain treated cancers with no evidence for 5 years
- Myelodysplastic syndrome or acute myeloid leukemia
- Symptomatic uncontrolled brain metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Weight loss over 10% during screening or ECOG performance status worsened to over 1
- Active infection needing systemic therapy
- Psychiatric or substance abuse disorders interfering with study cooperation
- Persistent toxicities over grade 2 from previous cancer therapy (except alopecia)
- Serious uncontrolled medical disorders or infections
- Unable to swallow oral medication or gastrointestinal disorders affecting absorption
- Immunocompromised, including known HIV positive status
- Active hepatitis B or C infection
- Prior treatment with PARP inhibitors including Olaparib
- Recent chemotherapy, targeted therapy, or radiotherapy within specified washout periods
- Bone-only metastatic disease from pancreatic cancer
- Major surgery within 2 weeks prior to treatment
- Current use of strong or moderate CYP3A inhibitors or inducers without required washout
- Previous allogenic bone marrow or double umbilical cord blood transplant
- Recent whole blood transfusions within 120 days
- Participation in another investigational study within 4 weeks
- Known hypersensitivity to Olaparib or its ingredients
- Uncontrolled cardiac conditions or congenital long QT syndrome
- Conditions or abnormalities that could confound trial results or prevent full participation
- Benign or uncertain significance PALB2 gene variants
- Non-adenocarcinoma pancreatic cancers
- Pregnancy, breastfeeding, or plans to conceive or father children during the study period
- Investigator judgment of inability to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aou Modena
Modena, Italy, 41125
Actively Recruiting
Research Team
L
LAURA CORTESI, MD
CONTACT
F
FEDERICA CAGGIA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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