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

NCT06783140 | Recruiting Phase 2 DMC

• 2 other identifiers: PLATINUM-CANCAPCR 24-5124
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Pancreatic Cancer, Advanced or Metastatic; BRCA1/2 Mutation; PALB2 Gene Mutation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Progression-free Survival (PFS)

  6 years

• Duration of Response (DoR)

  6 years

• CA19-9 Response

  6 years

• Number of Adverse Events

  6 years

Study Arms (2)

Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine)

EXPERIMENTAL

Nab-paclitaxel 100 mg/m2 + cisplatin 25 mg/m2 + gemcitabine 800 mg/m2 on days 1 and 15 of every cycle.

Drug: Nab paclitaxel; Drug: Gemcitabine; Drug: Cisplatin

Arm 2 - Nab-paclitaxel+gemcitabine

ACTIVE COMPARATOR

Nab-paclitaxel 125 mg/m2 + gemcitabine 1000 mg/m2 on days 1 and 15 of every cycle.

Drug: Nab paclitaxel; Drug: Gemcitabine

Interventions

Cisplatin DRUG

Cisplatin is an alkylating-like inorganic platinum agent (cis-diamminedichloroplatinum) with antineoplastic activity.

Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine)

Nab paclitaxel DRUG

Paclitaxel Powder For Injectable Suspension Nanoparticle, Albumin-bound Paclitaxel is an albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity.

Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine); Arm 2 - Nab-paclitaxel+gemcitabine

Gemcitabine DRUG

Gemcitabine is a hydrochloride salt of an analogue of the antimetabolite nucleoside deoxycytidine with antineoplastic activity.

Arm 1- NABPLAGEM (Nab-paclitaxel+Cisplatin+Gemcitabine); Arm 2 - Nab-paclitaxel+gemcitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis

Interventions

Taxes; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Erica S Tsang, MD

  Princess Margaret Cancer Centre/University Health Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica S Tsang, MD

CONTACT

416-946-4501; erica.tsang@uhn.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 20, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): June 2, 2031
• Study Completion (Estimated): June 2, 2031
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

CA (1)