Study of NABPLAGEM vs. Nab-Paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Pancreatic Cancer (PLATINUM-CAN)

Comparing Second-Line NABPLAGEM vs. Nab-paclitaxel/Gemcitabine in BRCA1/2 or PALB2 Mutant Metastatic Pancreatic Ductal Adenocarcinoma

This study will compare two different regimens for patients with BRCA1/2 or PALB2 mutated metastatic pancreatic cancer after progression on first-line FOLFIRINOX.

Study Overview

• Status: Recruiting
• Conditions: PALB2 Gene Mutation; BRCA1/2 Mutation; Pancreatic Cancer, Advanced or Metastatic
• Intervention / Treatment: Drug: Nab paclitaxel; Drug: Gemcitabine; Drug: Cisplatin

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Erica S Tsang, MD; Phone Number: 5498 416-946-4501; Email: erica.tsang@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Recruiting
      • Princess Margaret Cancer Centre
      • Contact: Erica S Tsang, MD; Phone Number: 5498 416-946-4501; Email: erica.tsang@uhn.ca
      • Principal Investigator: Erica S Tsang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Metastatic pancreatic adenocarcinoma. Adenosquamous carcinoma, squamous carcinoma, acinar cell carcinoma, and carcinoma not otherwise specified are also acceptable.
• BRCA1/2 or PALB2 mutation (somatic or germline).
• Measurable disease.
• Potential trial participants should have recovered from clinically significant adverse events of their most recent therapy/intervention prior to enrollment.

• Clinical or radiographic progression on first-line FOLFIRINOX (or NALIRIFOX) for metastatic disease.

  • Patients whose front-line chemotherapy was required to be simplified due to toxicity associated with any of the constituent components of FOLFIRINOX/NALIRIFOX (e.g. simplified to FOLFOX, FOLFIRI, 5-FU (including capecitabine)) will be eligible.
  • Patients with progressive disease while on maintenance PARP inhibitor treatment after FOLFIRINOX (or NALIRIFOX), irrespective of how long ago they received FOLFIRINOX/NALIRIFOX, will also be eligible.
  • Patients who develop metastatic disease during or within 6 months after completing FOLFIRINOX/NALIRIFOX in either the locally advanced or adjuvant/neoadjuvant settings will be eligible.
• Age 18 years or older.
• Ability to understand and willing to sign a written informed consent document.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 (Karnofsky Performance Status ≥60).
• Required Initial Laboratory Values
• Not pregnant and not nursing.

Exclusion Criteria:

• Patients may not have received prior cisplatin for their pancreatic cancer in any setting.
• Patients with > grade 2 peripheral sensory neuropathy are not eligible.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for at least 8-weeks. Patients with known, new or progressive brain metastases (active brain metastases) or leptomeningeal disease are ineligible.
• HIV-infected patients on effective anti-retroviral therapy with undetectable viral load anytime within 6 months prior to registration are eligible for this trial.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• Concomitant Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine); Nab-paclitaxel 100 mg/m2 + cisplatin 25 mg/m2 + gemcitabine 800 mg/m2 on days 1 and 15 of every cycle.	Drug: Nab paclitaxel; Paclitaxel Powder For Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is an albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity.; Drug: Gemcitabine; Gemcitabine is a hydrochloride salt of an analogue of the antimetabolite nucleoside deoxycytidine with antineoplastic activity.; Drug: Cisplatin; Cisplatin is an alkylating-like inorganic platinum agent (cis-diamminedichloroplatinum) with antineoplastic activity.
Active Comparator: Arm 2 - Nab-paclitaxel+gemcitabine; Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 on days 1 and 15 of every cycle.	Drug: Nab paclitaxel; Paclitaxel Powder For Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is an albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity.; Drug: Gemcitabine; Gemcitabine is a hydrochloride salt of an analogue of the antimetabolite nucleoside deoxycytidine with antineoplastic activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	The proportion of patients who achieve complete response (CR) or partial response (PR)	12 months
Overall Survival (OS) Time	The time form the date of randomization to the date of death	6 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Time from the date of randomization to the date of first documented disease progression or death	6 years
Duration of Response (DoR)	The time that criteria are met for complete response (CR) or partial response (PR) until the first date that recurrence or disease progression is objectively documented.	6 years
CA19-9 Response	Percentage decrease in CA19-9	6 years
Number of Adverse Events		6 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Erica S Tsang, MD, Princess Margaret Cancer Centre/University Health Network

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2025
• Primary Completion (Estimated): June 2, 2031
• Study Completion (Estimated): June 2, 2031

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 20, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Pancreatic Neoplasms; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Health Care Economics and Organizations; Platinum Compounds; Economics; Gemcitabine; Cisplatin; Taxes
• Other Study ID Numbers: PLATINUM-CAN; CAPCR 24-5124 (Other Identifier: University Health Network)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No