Trial Outcomes & Findings for Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic Adenocarcinoma (NCT NCT03915444)
NCT ID: NCT03915444
Last Updated: 2026-04-23
Results Overview
Evaluate the 12-month OS rate in patients with metastatic Pancreatic ductal adenocarcinoma (PDA) treated with nab-paclitaxel plus cisplatin plus gemcitabine
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
12 months
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
NabCG
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
nab-Paclitaxel + Cisplatin + Gemcitabine: Cisplatin 25mg/m2 in 500 mL of normal saline (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.
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
NabCG
n=42 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=60 Participants
|
|
Age, Continuous
Median (range)
|
66.8 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=60 Participants
|
|
KPS - Karnofsky Performance Status
100%
|
5 Participants
n=60 Participants
|
|
KPS - Karnofsky Performance Status
90%
|
18 Participants
n=60 Participants
|
|
KPS - Karnofsky Performance Status
80%
|
17 Participants
n=60 Participants
|
|
KPS - Karnofsky Performance Status
70%
|
2 Participants
n=60 Participants
|
|
Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA)
CA 19-9 > 35
|
35 Participants
n=60 Participants
|
|
Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA)
CA 19-9 < 35
|
6 Participants
n=60 Participants
|
|
Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA)
CA 19-9 not collected
|
1 Participants
n=60 Participants
|
|
Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA)
CA 125 > 35*
|
5 Participants
n=60 Participants
|
|
Tumor Markers cancer antigen (CA) 19-9 (or CA 125, or CEA)
CEA > 3*
|
3 Participants
n=60 Participants
|
|
Primary tumor location on pancreas
Body
|
15 Participants
n=60 Participants
|
|
Primary tumor location on pancreas
Head
|
16 Participants
n=60 Participants
|
|
Primary tumor location on pancreas
Head and Body
|
1 Participants
n=60 Participants
|
|
Primary tumor location on pancreas
Tail
|
10 Participants
n=60 Participants
|
|
Prior Cancer Treatment
Adjuvant chemotherapy
|
4 Participants
n=60 Participants
|
|
Prior Cancer Treatment
Prior PDA surgery
|
3 Participants
n=60 Participants
|
|
Prior Cancer Treatment
Radiotherapy
|
0 Participants
n=60 Participants
|
|
Neutrophil-to-lymphocyte ratio (NLR)
≤ 5
|
22 Participants
n=60 Participants
|
|
Neutrophil-to-lymphocyte ratio (NLR)
> 5
|
20 Participants
n=60 Participants
|
|
MD Anderson's Symptom Inventory-GI (MDASI-GI)
Core symptom severity score
|
2.5 symptom score
STANDARD_DEVIATION 1.7 • n=60 Participants
|
|
MD Anderson's Symptom Inventory-GI (MDASI-GI)
Overall symptom distress (interference) score
|
3.1 symptom score
STANDARD_DEVIATION 2.9 • n=60 Participants
|
|
MD Anderson's Symptom Inventory-GI (MDASI-GI)
Gastrointestinal module score
|
1.8 symptom score
STANDARD_DEVIATION 1.7 • n=60 Participants
|
|
Brief Pain Inventory (BPI)
Pain severity
|
2.7 pain score
STANDARD_DEVIATION 2.1 • n=60 Participants
|
|
Brief Pain Inventory (BPI)
Pain interference
|
3.1 pain score
STANDARD_DEVIATION 2.9 • n=60 Participants
|
PRIMARY outcome
Timeframe: 12 monthsEvaluate the 12-month OS rate in patients with metastatic Pancreatic ductal adenocarcinoma (PDA) treated with nab-paclitaxel plus cisplatin plus gemcitabine
Outcome measures
| Measure |
NabCG
n=42 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
12- Month Overall Survival (OS)
|
16 Participants
|
SECONDARY outcome
Timeframe: 12-monthsAdverse 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 (%)
Outcome measures
| Measure |
NabCG
n=42 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Toxicity Adverse Events (Grade ≥ 3)
Musculoskeletal and connective tissue disorders - Generalized muscle weakness : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Nervous system disorders - Peripheral sensory neuropathy : Total
|
3 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Renal and urinary disorders - Acute kidney injury : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Gastrointestinal disorders - Enterocolitis : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Gastrointestinal disorders - Mucositis oral : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
General disorders and administration site conditions - Fatigue : Total
|
3 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
General disorders and administration site conditions - Gait disturbance : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Infections and infestations - skin infestations : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Investigations - Lymphocyte count decreased : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Investigations - Neutrophil count decreased : Total
|
11 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Investigations - Platelet count decreased : Total
|
27 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Investigations - White blood cell decreased : Total
|
7 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Metabolism and nutrition disorders - Anorexia : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Metabolism and nutrition disorders - Hypocalcemia : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Metabolism and nutrition disorders - Hypokalemia : Total
|
4 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Metabolism and nutrition disorders - Hyponatremia : Total
|
1 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Blood and lymphatic system disorders - Anemia : Total
|
20 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Gastrointestinal disorders - Colitis : Total
|
2 Participants
|
|
Toxicity Adverse Events (Grade ≥ 3)
Gastrointestinal disorders - Diarrhea : Total
|
5 Participants
|
SECONDARY outcome
Timeframe: 63 daysPopulation: A total of 36 participants had one or more follow-up scans available for tumor assessment, plus one additional patient had documented clinical disease progression before any follow-up scan occurred. Of these 37, 0 (0.0%) had complete response (CR), regardless of normalized CA 19-9 (one-sided 97.5% Confidence interval (CI), 0.0-9.5%).
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).
Outcome measures
| Measure |
NabCG
n=37 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Complete Response Rate (CR)
|
0 percentage of participants
Interval 0.0 to 9.5
|
SECONDARY outcome
Timeframe: 63 daysPopulation: A total of 34 participants had follow-up scans available for tumor assessment at 9 weeks, plus one additional participant had documented clinical disease progression before any follow-up scan occurred. Of these 35, 0 achieved complete response (CR), 12 (34.3%; 95% CI, 19.1-52.2%) achieved partial response (PR), and 19 (54.3%; 95% CI, 36.6-71.2%) achieved stable disease (SD), yielding a total of 31 (88.6%; 95% CI, 73.3-96.8%) for the disease control rate 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)
Outcome measures
| Measure |
NabCG
n=34 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Disease Control Rate (CR, PR, SD) at 9 Weeks
Complete Response (CR)
|
0 Participants
|
|
Disease Control Rate (CR, PR, SD) at 9 Weeks
Partial Response (PR)
|
12 Participants
|
|
Disease Control Rate (CR, PR, SD) at 9 Weeks
Stable Disease (SD)
|
19 Participants
|
SECONDARY outcome
Timeframe: End of Study (36 months)Population: Of 42 participants with tumor marker data, n=35 expressed CA 19-9 (\> 35 U/mL). Of the remaining participants, n=5 expressed CA 125, and n=3 did not express CA 19-9 or CA 125 and were excluded from this analysis. End-of-study is defined as the last available measure after baseline.
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.
Outcome measures
| Measure |
NabCG
n=42 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Change in CA 19-9 or CA 125
CA 19-9
|
-1047 U/mL
Interval -9675.0 to -44.0
|
|
Change in CA 19-9 or CA 125
CA 125
|
-67 U/mL
Interval -127.0 to -51.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 36 participants whose baseline tumor marker levels were twice the upper limit of normal and could therefore be included in this analysis.
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).
Outcome measures
| Measure |
NabCG
n=36 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Rate of Tumor Marker Normalization
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline to Midpoint (C4/D1)Population: In a linear mixed-model average Core symptom severity, overall symptom distress (interference), and average gastrointestinal module were assessed for change.
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)).
Outcome measures
| Measure |
NabCG
n=28 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)
Overall symptom distress (interference)
|
-0.3 score on a scale
Interval -0.9 to 0.0
|
|
Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)
Gastrointestinal module
|
0.0 score on a scale
Interval -0.6 to 0.2
|
|
Quality of Life: MD Anderson Symptom Inventory (MDASI-GI)
Core symptom severity
|
-0.5 score on a scale
Interval -1.3 to -0.1
|
SECONDARY outcome
Timeframe: Baseline to Midpoint (C4/D1)Population: In a linear mixed-model, average Pain severity and average Pain interference were measured to assess change.
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)
Outcome measures
| Measure |
NabCG
n=42 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Pain Control: Brief Pain Inventory (BPI)
Pain Interference
|
-0.4 change in pain score
Interval -1.1 to 0.0
|
|
Pain Control: Brief Pain Inventory (BPI)
Pain severity
|
-0.8 change in pain score
Interval -2.5 to 0.0
|
POST_HOC outcome
Timeframe: 18 monthsEvaluate the 18-month OS rate in patients with metastatic PDA treated with nab-paclitaxel plus cisplatin plus gemcitabine
Outcome measures
| Measure |
NabCG
n=42 Participants
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
18 - Month Overall Survival
|
11 Participants
|
Adverse Events
NabCG
Serious events: 28 serious events
Other events: 42 other events
Deaths: 37 deaths
Serious adverse events
| Measure |
NabCG
n=42 participants at risk
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Immune system disorders
Fever
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.8%
2/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Cholecystitis
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Enterocolitis
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Blood and lymphatic system disorders
Viremia
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Cardiac disorders
Pulmonary embolism
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Blood and lymphatic system disorders
Hyponatremia
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
General disorders
Dehydration
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Infections and infestations
Abdominal infection
|
4.8%
2/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Investigations
Platelet count decreased
|
4.8%
2/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Cardiac disorders
Cardiac arrest
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Infections and infestations
Skin infection
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Biliary tract infection
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Psychiatric disorders
Anxiety disorder
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Blood and lymphatic system disorders
Bacteremia
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Vascular disorders
Thromboembolic event
|
2.4%
1/42 • Number of events 2 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Vascular disorders
Stroke
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Renal and urinary disorders
Urinary tract infection
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Rectal ulcer
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
Other adverse events
| Measure |
NabCG
n=42 participants at risk
nab-paclitaxel 125mg/m2 cisplatin 25 mg/m2 gemcitabine 1000 mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days
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.
|
|---|---|
|
Gastrointestinal disorders
Mucositis oral
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
General disorders
Fatigue
|
7.1%
3/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
General disorders
Gait Distrubance
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Investigations
Lymphocyte count decreased
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Investigations
Neutrophil count decreased
|
26.2%
11/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Investigations
Platelet count decreased
|
61.9%
26/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Investigations
White blood cell decreased
|
16.7%
7/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Metabolism and nutrition disorders
Anorexia
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.5%
4/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
3/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Blood and lymphatic system disorders
Anemia
|
47.6%
20/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
|
Gastrointestinal disorders
Diarrhea
|
9.5%
4/42 • 36 Months
Adverse events (grade ≥ 3) that were possibly, probably, or definitely related to study drug or study procedure, by severity (highest grade per person, per preferred term), n (%)
|
Additional Information
Gayle Jameson, MSN, ACNP-BC, AOCN
HonorHealth Research Institute
Phone: 4803231350
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place