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CompletedNCT03915444Updated Apr 23, 2026Results posted

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

A Phase 2 interventional study of NabCG (nab-Paclitaxel + Cisplatin + Gemcitabine) in Pancreatic Ductal Adenocarcinoma, sponsored by HonorHealth Research Institute. Completed at 4 sites in United States. Open to participants aged 18 Years to 105 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by HonorHealth Research Institute · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 105 Years
Sex
All
01

Study 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 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 Multiple cycles may be administered until the patient is withdrawn from therapy.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.

02

Conditions studied

  • Pancreatic Ductal Adenocarcinoma
03

In context

Lead sponsor

HonorHealth Research Institute is the lead sponsor of 22 studies on the registry; 1 is open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 105 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years of age; male or female
  2. Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma.
  3. Capable of providing informed consent and complying with trial procedures.
  4. Karnofsky Performance Status (KPS) of ≥ 70%.
  5. Life expectancy ≥ 12 weeks.
  6. Measurable tumor lesions according to RECIST 1.1 criteria.
  7. \< Grade 2 pre-existing peripheral neuropathy per NCI CTCAE, Version 5.0
  8. 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.

  9. 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

  10. 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:

    1. 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
    2. 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.
  11. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of study treatment.
  3. Exposure to any investigational agent within 4 weeks prior to initiation of study treatment.
  4. Evidence of central nervous system (CNS) metastasis (negative imaging study, if clinically indicated, within 4 weeks of Screening Visit).
  5. 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.
  6. Current, serious, clinically significant cardiac arrhythmias as determined by the investigator.
  7. History of HIV infection.
  8. Active, clinically significant serious infection requiring treatment with antibiotics, anti-virals or anti-fungals.
  9. Major surgery within 4 weeks prior to initiation of study treatment.
  10. 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.
  11. Any condition in the opinion of the principal investigator that is unstable and could jeopardize the patient's participation in the study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

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

    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

  • DrugNabCG (nab-Paclitaxel + Cisplatin + Gemcitabine)

    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

06

What researchers measure

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

    Time frame: 12 months

Secondary outcomes

  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 (%)

    Time frame: 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).

    Time frame: 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)

    Time frame: 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.

    Time frame: 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).

    Time frame: 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)).

    Time frame: 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)

    Time frame: Baseline to Midpoint (C4/D1)

07

Results

Posted Apr 23, 2026

Participant flow

Participant flow — Overall Study
MilestoneNabCG
Started42
Completed42
Not completed0

Outcome measures

Primary12- 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

Time frame:
12 months
Reported as:
Count of participants · Participants
12- Month Overall Survival (OS)
ParticipantsNabCG
12- Month Overall Survival (OS)16
SecondaryToxicity 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 (%)

Time frame:
12-months
Reported as:
Count of participants · Participants
Toxicity Adverse Events (Grade ≥ 3)
ParticipantsNabCG
Blood and lymphatic system disorders - Anemia : Total20
Gastrointestinal disorders - Colitis : Total2
Gastrointestinal disorders - Diarrhea : Total5
Gastrointestinal disorders - Enterocolitis : Total1
Gastrointestinal disorders - Mucositis oral : Total1
General disorders and administration site conditions - Fatigue : Total3
General disorders and administration site conditions - Gait disturbance : Total1
Infections and infestations - skin infestations : Total1
Investigations - Lymphocyte count decreased : Total1
Investigations - Neutrophil count decreased : Total11
Investigations - Platelet count decreased : Total27
Investigations - White blood cell decreased : Total7
Metabolism and nutrition disorders - Anorexia : Total1
Metabolism and nutrition disorders - Hypocalcemia : Total1
Metabolism and nutrition disorders - Hypokalemia : Total4
Metabolism and nutrition disorders - Hyponatremia : Total1
Musculoskeletal and connective tissue disorders - Generalized muscle weakness : Total1
Nervous system disorders - Peripheral sensory neuropathy : Total3
Renal and urinary disorders - Acute kidney injury : Total1
SecondaryComplete 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).

Time frame:
63 days
Reported as:
Number · percentage of participants
Complete Response Rate (CR)
percentage of participantsNabCG
Complete Response Rate (CR)0 (0 to 9.5)
SecondaryDisease 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)

Time frame:
63 days
Reported as:
Count of participants · Participants
Disease Control Rate (CR, PR, SD) at 9 Weeks
ParticipantsNabCG
Complete Response (CR)0
Partial Response (PR)12
Stable Disease (SD)19
SecondaryChange 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.

Time frame:
End of Study (36 months)
Reported as:
Median · U/mL
Change in CA 19-9 or CA 125
U/mLNabCG
CA 19-9-1047 (-9675 to -44.0)
CA 125-67 (-127 to -51)
Statistical analysis
  • NabCG · Wilcoxon signed-rank test · p = 0.001
  • NabCG · Wilcoxon signed-rank test · p = 0.438
SecondaryRate 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).

Time frame:
12 months
Reported as:
Count of participants · Participants
Rate of Tumor Marker Normalization
ParticipantsNabCG
Rate of Tumor Marker Normalization10
SecondaryQuality 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)).

Time frame:
Baseline to Midpoint (C4/D1)
Reported as:
Median · score on a scale
Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)
score on a scaleNabCG
Core symptom severity-0.5 (-1.3 to -0.1)
Overall symptom distress (interference)-0.3 (-0.9 to 0.0)
Gastrointestinal module0.0 (-0.6 to 0.2)
Statistical analysis
  • NabCG · Wilcoxon signed-rank test · p = 0.006
  • NabCG · Wilcoxon signed-rank test · p = 0.048
  • NabCG · Wilcoxon signed-rank test · p = 0.437
SecondaryPain 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)

Time frame:
Baseline to Midpoint (C4/D1)
Reported as:
Median · change in pain score
Pain Control: Brief Pain Inventory (BPI)
change in pain scoreNabCG
Pain severity-0.8 (-2.5 to 0.0)
Pain Interference-0.4 (-1.1 to 0.0)
Statistical analysis
  • NabCG · Wilcoxon signed-rank test · p = 0.013
  • NabCG · Wilcoxon signed-rank test · p = 0.032
Post-hoc18 - Month Overall Survival

Evaluate the 18-month OS rate in patients with metastatic PDA treated with nab-paclitaxel plus cisplatin plus gemcitabine

Time frame:
18 months
Reported as:
Count of participants · Participants
18 - Month Overall Survival
ParticipantsNabCG
18 - Month Overall Survival11

Adverse events

Collected over 36 Months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NabCG37/42 (88.1%)28/42 (66.7%)42/42 (100%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventNabCG
Abdominal PainGastrointestinal disorders2/42
Abdominal infectionInfections and infestations2/42
Platelet count decreasedInvestigations2/42
FeverImmune system disorders1/42
CholecystitisGastrointestinal disorders1/42
EnterocolitisGastrointestinal disorders1/42
DiarrheaGastrointestinal disorders1/42
ViremiaBlood and lymphatic system disorders1/42
Pulmonary embolismCardiac disorders1/42
HyponatremiaBlood and lymphatic system disorders1/42
Most frequent other events
Showing 10 of 15
Most frequent other events
EventNabCG
Platelet count decreasedInvestigations26/42
AnemiaBlood and lymphatic system disorders20/42
Neutrophil count decreasedInvestigations11/42
White blood cell decreasedInvestigations7/42
DiarrheaGastrointestinal disorders4/42
HypokalemiaMetabolism and nutrition disorders4/42
FatigueGeneral disorders3/42
Peripheral sensory neuropathyNervous system disorders3/42
ColitisGastrointestinal disorders1/42
Mucositis oralGastrointestinal disorders1/42

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)NabCG
<=18 years0
Between 18 and 65 years17
>=65 years25
Age, Continuous
Age, Continuous(years)NabCG
Median (range)66.8 (40.7 to 82.9)
Sex: Female, Male
Sex: Female, Male(Participants)NabCG
Female14
Male28
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NabCG
Hispanic or Latino5
Not Hispanic or Latino37
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NabCG
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American3
White37
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)NabCG
United States42
KPS - Karnofsky Performance Status
KPS - Karnofsky Performance Status(Participants)NabCG
100%5
90%18
80%17
70%2
Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA)
Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA)(Participants)NabCG
CA 19-9 > 3535
CA 19-9 < 356
CA 19-9 not collected1
CA 125 > 35*5
CEA > 3*3

5 further baseline measures are reported on the registry.

08

Study locations

4 sites
  • HonorHealth Research Institute
    Scottsdale, Arizona 85258, United States
  • University of Miami
    Miami, Florida 33136, United States
  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
  • Froedtert & Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 16, 2021
  • Informed consent form · Aug 2, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03915444
Lead sponsor
HonorHealth Research Institute
Collaborators
Celgene
Responsible party
Sponsor
First posted
Apr 16, 2019
Start date
Jul 15, 2019
Primary completion
May 13, 2022
Completion
Jan 23, 2023
Results posted
Apr 23, 2026
Last update
Apr 23, 2026

Study contacts

Gayle Jameson, ACNP-BC
principal investigator · HonorHealth Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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