NCT03915444

Brief Summary

This is a phase II open-label study evaluating the efficacy and safety of nab-paclitaxel cisplatin, and gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2019

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2023

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

April 23, 2026

Completed
Last Updated

April 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.8 years

First QC Date

April 5, 2019

Results QC Date

January 3, 2024

Last Update Submit

April 21, 2026

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 12- Month Overall Survival (OS)

    Evaluate the 12-month OS rate in patients with metastatic Pancreatic ductal adenocarcinoma (PDA) treated with nab-paclitaxel plus cisplatin plus gemcitabine

    12 months

Secondary Outcomes (7)

  • Toxicity Adverse Events (Grade ≥ 3)

    12-months

  • Complete Response Rate (CR)

    63 days

  • Disease Control Rate (CR, PR, SD) at 9 Weeks

    63 days

  • Change in CA 19-9 or CA 125

    End of Study (36 months)

  • Rate of Tumor Marker Normalization

    12 months

  • +2 more secondary outcomes

Study Arms (1)

NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)

EXPERIMENTAL

nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days

Drug: NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)

Interventions

NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)DRUG

Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days. Gemcitabine 1000mg/m2 in 500 mL\* over 30 minute IV infusion on days 1 and 8 repeated every 21 days. Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days.

Also known as: NabCG
NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years of age; male or female
  • Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
  • Capable of providing informed consent and complying with trial procedures.
  • Karnofsky Performance Status (KPS) of ≥ 70%.
  • Life expectancy ≥ 12 weeks.
  • Measurable tumor lesions according to RECIST 1.1 criteria.
  • \< Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
  • Patient has acceptable coagulation status as indicated by an international normalized ratio (INR) ≤1.5 x ULN. Patients on anticoagulation can be included at the discretion of the investigator.
  • Patients must have normal organ and marrow function as defined below:
  • Absolute neutrophil count ≥1,500/mm3
  • Platelet concentration ≥100,000/mm3 with no platelet transfusions within 7 days prior to laboratory sample
  • Hemoglobin \> 9.0g/dL
  • Hematocrit level \> 27%
  • Total bilirubin within 1.25 times institutional upper limit of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 10 × institutional ULN
  • +5 more criteria

You may not qualify if:

  • Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Prior treatments in the neoadjuvant and/or adjuvant setting with gemcitabine and/or Fluorouracil (5-FU) based therapies or gemcitabine and/or 5FU administered as a radiation sensitizer are allowed, provided at least 6 months have elapsed since completion of the last dose and no lingering toxicities are present.
  • Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
  • Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
  • Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
  • History of other malignancies (except cured basal cell carcinoma, superficial bladder cancer or carcinoma in situ of the cervix) unless documented free of cancer for ≥5 years.
  • Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
  • History of HIV infection.
  • Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
  • Major surgery within 4 weeks prior to initiation of study treatment.
  • Any condition in the opinion of the principal investigator that might interfere with the patient's participation in the study or in the evaluation of the study results.
  • Any condition in the opinion of the principal investigator that is unstable and could jeopardize the patient's participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Interventions

130-nm albumin-bound paclitaxelCisplatinGemcitabine

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Gayle Jameson, MSN, ACNP-BC, AOCN
Organization
HonorHealth Research Institute
clinicaltrials@honorhealth.com
4803231350

Study Officials

  • Gayle Jameson, ACNP-BC

    HonorHealth Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 16, 2019

Study Start

July 15, 2019

Primary Completion

May 13, 2022

Study Completion

January 23, 2023

Last Updated

April 23, 2026

Results First Posted

April 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)