Trial Outcomes & Findings for Nab-Pac+Cis+Gem in Pts w Previously Untreated Metastatic PDA (NCT NCT01893801)

Last Updated: 2019-05-29

Results Overview

The primary objectives of this study is to pursue treatment of 25 individual patients with previously untreated metastatic pancreatic ductal adenocarcinoma (PDA) to evaluate: Complete response rate as defined by computed tomography (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). We expect to accomplish this in \> or = to 5% of patients. When a complete response (CR) is documented, a confirmatory PET scan will be obtained. If 1 or more of 10 patients demonstrate a complete response (CR), study will continue to enroll to a total of 25 patients. If intolerable adverse events or no clinical benefit are noted in the first 6 patients, study will discontinue enrollment.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

25 participants

Primary outcome timeframe

1 yr.

Results posted on

2019-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Of the 6 patients with normal CA19-9 level at baseline, 4 (66.7%) had baseline CEA data available.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=25 Participants This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=25 Participants
Age, Categorical >=65 years	13 Participants n=25 Participants
Age, Continuous	64.4 years STANDARD_DEVIATION 7.94 • n=25 Participants
Sex: Female, Male Female	11 Participants n=25 Participants
Sex: Female, Male Male	14 Participants n=25 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=25 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=25 Participants
Race (NIH/OMB) Asian	1 Participants n=25 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=25 Participants
Race (NIH/OMB) Black or African American	0 Participants n=25 Participants
Race (NIH/OMB) White	24 Participants n=25 Participants
Race (NIH/OMB) More than one race	0 Participants n=25 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=25 Participants
CA19-9 Status at Baseline Abnormal	19 Participants n=25 Participants
CA19-9 Status at Baseline Normal	6 Participants n=25 Participants
CEA Status at Baseline (if CA19-9 Normal at Baseline) Abnormal	2 Participants n=4 Participants • Of the 6 patients with normal CA19-9 level at baseline, 4 (66.7%) had baseline CEA data available.
CEA Status at Baseline (if CA19-9 Normal at Baseline) Normal	2 Participants n=4 Participants • Of the 6 patients with normal CA19-9 level at baseline, 4 (66.7%) had baseline CEA data available.
CA125 Status at Baseline (if CA19-9 Normal at Baseline) Abnormal	2 Participants n=4 Participants • Of the 6 patients with normal CA19-9 level at baseline, 4 (66.7%) had baseline CA125 data available.
CA125 Status at Baseline (if CA19-9 Normal at Baseline) Normal	2 Participants n=4 Participants • Of the 6 patients with normal CA19-9 level at baseline, 4 (66.7%) had baseline CA125 data available.

PRIMARY outcome

Timeframe: 1 yr.

Population: Best Response on study was assessed for patients with at least one evaluation for response while evaluable during the study. One patient achieved CR 32 days after the last dose on therapy and had a best response of PR prior to this assessment. The patient is identified as having a best response of CR in this table.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=24 Participants This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Complete Response Rate N/A	0 Participants
Complete Response Rate CR	2 Participants
Complete Response Rate PR	15 Participants
Complete Response Rate SD	4 Participants
Complete Response Rate PD	3 Participants

SECONDARY outcome

Timeframe: Over the course of the subjects' treatment on study, approx 1 year

Population: All patients on study were evaluated for maximum grade of treatment-related toxicity.

Frequency of treatment-related toxicities

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=25 Participants This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Treatment-Related Toxicities Maximum Grade 3 Treatment-Related Adverse Event	12 Participants
Treatment-Related Toxicities Maximum Grade 4 Treatment-Related Adverse Event	9 Participants
Treatment-Related Toxicities Maximum Grade 5 Treatment-Related Adverse Event	1 Participants
Treatment-Related Toxicities No Grade 3-5 Treatment-Related Adverse Event	3 Participants

SECONDARY outcome

Timeframe: Over the course of the subjects' treatment on study, approx 1 year

Population: All patients with a non-zero CA 19-9 measurement at baseline and at least one CA 19-9 measurement on-study were evaluated for percentage change of CA19-9. Of the 25 patients on study, 22 met the criteria for analysis (one had baseline CA 19-9 of zero; two had no post-baseline CA 19-9 measurements).

Percentage change in CA 19-9 from baseline values

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=22 Participants This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Percentage Change in CA 19-9	-47.7 percentage change CA 19-9 from baseline Standard Deviation 77.13

SECONDARY outcome

Timeframe: Over the course of the subjects' treatment and participation in study, approx 18 mos

Population: All patients were evaluated for overall survival.

Overall survival is defined as the time from study enrollment until death from any cause.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=25 Participants This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Overall Survival	16.4 months Interval 10.2 to 25.3

SECONDARY outcome

Timeframe: Over the course of the subjects' treatment and participation in study, approx 18 mos

Population: All patients were evaluated for progression-free survival.

Progression-free survival is defined as the time from study enrollment until the first documented tumor progression (using RECIST 1.1 criteria) or death from any cause.

Outcome measures

Outcome measures
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=25 Participants This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Progression-Free Survival	10.1 months Interval 6.0 to 12.5

Adverse Events

Nab-Paclitaxel+Cisplatin+Gemcitabine

Serious events: 12 serious events

Other events: 24 other events

Deaths: 21 deaths

Serious adverse events

Serious adverse events
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=25 participants at risk This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Infections and infestations Acute cryptosporidiosis	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Infections and infestations Lung infection	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Infections and infestations Sepsis	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Blood and lymphatic system disorders Anemia	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Blood and lymphatic system disorders Febrile neutropenia	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
General disorders Fever	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Investigations Platelet count decreased	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Metabolism and nutrition disorders Dehydration	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Nervous system disorders Stroke	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Cardiac disorders Cardiac arrest	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Gastrointestinal disorders Nausea	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Epistaxis	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.

Other adverse events

Other adverse events
Measure	Nab-Paclitaxel+Cisplatin+Gemcitabine n=25 participants at risk This is a Phase Ib/II open-label, pilot study evaluating the preliminary efficacy and safety of Nab-Paclitaxel 125mb/m2, Cisplatin 25mg/m2, and Gemcitabine 1000mg/m2, all administered intravenously (IV) on Days 1 and 8 every 21 days until development of toxicity that is unacceptable in the opinion of the patient or the Investigator or upon disease progression. Nab-Paclitaxel: 25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle Cisplatin: 25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle Gemcitabine: 1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
Investigations Platelet count decreased	72.0% 18/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Investigations Neutrophil count decreased	24.0% 6/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Investigations White blood cell decreased	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Investigations Lymphocyte count decreased	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Investigations Lymphocyte count increased	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Blood and lymphatic system disorders Anemia	28.0% 7/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Infections and infestations Lung infection	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Infections and infestations Anorectal infection	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Infections and infestations Enterocolitis infectious	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Metabolism and nutrition disorders Hyperglycemia	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Metabolism and nutrition disorders Hypokalemia	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Metabolism and nutrition disorders Hyponatremia	8.0% 2/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Metabolism and nutrition disorders Hypophosphatemia	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Gastrointestinal disorders Diarrhea	12.0% 3/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Gastrointestinal disorders Nausea	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Gastrointestinal disorders Vomiting	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
General disorders Fatigue	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Nervous system disorders Peripheral motor neuropathy	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.
Vascular disorders Thromboembolic event	4.0% 1/25 • Adverse event data were collected during the period starting with initial dose of study drug and ending at the time the patient went off study or 30 days after the patient's last dose of study drug, whichever was later. The definitions of adverse event and serious adverse event for this study match the definitions from clinicaltrials.gov.

Additional Information

Adam Rosenthal

Cancer Research and Biostatistics

Phone: (206) 839-1797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place