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

NCT ID: NCT06783140

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-10
• Study Completion Date: 2031-06-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nab paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Cisplatin

Intervention Type: DRUG

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

Arm 2 - Nab-paclitaxel+gemcitabine

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

Group Type: ACTIVE_COMPARATOR

Nab paclitaxel

Intervention Type: DRUG

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

Gemcitabine

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Gemcitabine

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

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erica S Tsang, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre/University Health Network

Locations

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Erica S Tsang, MD

Role: CONTACT

erica.tsang@uhn.ca

416-946-4501 ext. 5498

Facility Contacts

Erica S Tsang, MD

Role: primary

erica.tsang@uhn.ca

416-946-4501 ext. 5498

Other Identifiers

CAPCR 24-5124

Identifier Type: OTHER

Identifier Source: secondary_id

PLATINUM-CAN

Identifier Type: -

Identifier Source: org_study_id