Actively Recruiting
Study of NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Pancreatic Cancer
Led by University Health Network, Toronto · Updated on 2025-12-05
10
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will compare two different regimens for patients with BRCA1/2 or PALB2 mutated metastatic pancreatic cancer after progression on first-line FOLFIRINOX.
CONDITIONS
Official Title
Study of NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Metastatic pancreatic adenocarcinoma or related carcinoma types including adenosquamous, squamous, acinar cell, or carcinoma not otherwise specified
- Presence of BRCA1/2 or PALB2 mutation (somatic or germline)
- Measurable disease
- Recovered from significant side effects of most recent therapy before enrollment
- Disease progression on first-line FOLFIRINOX or NALIRIFOX for metastatic disease
- Patients who had simplified chemotherapy due to toxicity from FOLFIRINOX/NALIRIFOX components
- Patients progressing during maintenance PARP inhibitor treatment after FOLFIRINOX/NALIRIFOX
- Patients developing metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX
- Age 18 years or older
- Ability to understand and sign informed consent
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 or Karnofsky Performance Status ≥60
- Required initial laboratory values met
- Not pregnant and not nursing
You will not qualify if you...
- Prior treatment with cisplatin for pancreatic cancer in any setting
- Peripheral sensory neuropathy greater than grade 2
- Active or progressive brain metastases or leptomeningeal disease
- Known untreated or progressive brain metastases
- Chronic treatment with strong CYP3A4 inhibitors or inducers unless discontinued 14 days before study
- HIV infection without effective anti-retroviral therapy or detectable viral load within 6 months
- Active hepatitis B or C infection not controlled or untreated
- Other malignancies interfering with safety or efficacy assessments
- Pregnancy or nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
E
Erica S Tsang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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