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Pancreatic Ductal AdenocarcinomaPhase 2NCT03915444

Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic Adenocarcinoma

A Phase 2 study testing NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine) in people with Pancreatic Ductal Adenocarcinoma, run by HonorHealth Research Institute at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 105 years
Conditions the study is for
Pancreatic Ductal Adenocarcinoma
What is being tested?
NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
4 sitesUnited States
Study dates
15 Jul 2019to 23 Jan 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 105 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • < 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
  • Serum creatinine <1.5 mg/dl
  • Females of child-bearing potential (defined as a sexually mature woman who (1) has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries] or (2) has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must:
  • Either commit to true abstinence* from heterosexual contact (which must be reviewed on a monthly basis), or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting IP therapy (including dose interruptions), and while on study medication or for a longer period if required by local regulations following the last dose of IP; and
  • Have a negative serum pregnancy test (β -hCG) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy. This applies even if the subject practices true abstinence* from heterosexual contact.
  • Male subjects must practice true abstinence* or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for 6 months following discontinuation from study treatment, even if he has undergone a successful vasectomy.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Miami

    Miami, Florida, 33136

  • Froedtert & Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: A Phase II Trial of Nab-Paclitaxel Plus Cisplatin Plus Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma

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.

Read the detailed description

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.

An individual cycle of therapy will be defined as Days 1 and 8 every 21 days. Multiple cycles may be administered until the patient is withdrawn from therapy.

Overall response rates as well as individual categories of response complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) will be determined using RECIST 1.1. Time-to-event endpoints, including progression-free survival (PFS) and overall survival (OS) will be assessed using the Kaplan-Meier method. Evaluation of stable disease at 9 weeks will also be assessed. Toxicity (adverse events) will be recorded using the NCI CTCAE, version 5.0.

Being tested
NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called NabCG

    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.

Study groups in NCT03915444
Study groupRoleWhat they receive
NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)Experimentalnab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
Receives: Drug: NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (7)

  1. Toxicity Adverse Events (Grade ≥ 3)

    Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per event term), n (%)

    Measured: 12-months

  2. Complete Response Rate (CR)

    Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN).

    Measured: 63 days

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

    To determine the preliminary efficacy (Disease control rate of CR+ PR+SD X 9 weeks) of the combination of nanoparticle albumin- bound paclitaxel + cisplatin + gemcitabine (NABPLAGEM) in patients with stage IV metastatic pancreatic cancer.complete response rate( RECIST 1.1), disease control rate at 9 weeks, Change and rates of normalization in CA 19-9 (or Ca125 or CEA if not expressers of CA 19-9)

    Measured: 63 days

  4. Change in CA 19-9 or CA 125

    Change in carbohydrate antigen 19-9 (CA 19-9) or cancer antigen 125 (CA 125). Both CA 19-9 and CA 125 are markers of tumor burden and treatment response.

    Measured: End of Study (36 months)

  5. Rate of Tumor Marker Normalization

    Complete response rate as defined by CT scan using RECIST 1.1 criteria and CA 19-9 (or CA 125, or CEA if not expressers of CA 19-9) down to normal limits (from at least > 2X ULN).

    Measured: 12 months

  6. Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)

    The MD Anderson Symptom Inventory for gastrointestinal cancer (MDASI-GI) is a site-specific MDASI module. Along with the core MDASI's 13 symptom items and 6 interference items, the MDASI-GI also assesses 5 symptoms specific to gastrointestinal cancer. Average Symptom severity Scores were measured to assess change in symptoms over time (Core Symptom Scoring: 0 - Not Present to 10 - As Bad as you can imagine; Overall symptom distress (Interference) Scoring: 0-Did not interfere to 10-Interfeard completely; Gastrointestinal Module: 0 (symptom has not been present) to 10 (the symptom was as bad as you can imagine it could be)).

    Measured: Baseline to Midpoint (C4/D1)

  7. Pain Control: Brief Pain Inventory (BPI)

    The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. The BPI has been translated into dozens of languages, and it is widely used in both research and clinical settings. Average scores were measured (Scoring scale: Pain Severity: 0 - No Pain to 10 - Pain as bad as you can imagine; Pain Interference 0-Does not interfere to 10 - Completely Interferes)

    Measured: Baseline to Midpoint (C4/D1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2019
  2. Study start15 Jul 2019
  3. Primary completion13 May 2022
  4. Study completion23 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03915444
Sponsor's protocol ID
AX-CL-PANC-PI-13301
Status last verified
Mar 2026
First submitted
5 Apr 2019
Last updated
23 Apr 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine) in people with Pancreatic Ductal Adenocarcinoma, run by HonorHealth Research Institute at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12- Month Overall Survival (OS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03915444.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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