Trial Outcomes & Findings for Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD) (NCT NCT03415854)

Last Updated: 2026-05-12

Results Overview

Best overall response (BOR) is defined as the best tumor response recorded 9 weeks after treatment initiation Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1). Responses are categorized as: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; stable disease (SD), no change in target lesion size; and progressive disease (PD), ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions. MRI completed every 3 cycles of treatment to determine if the tumor responded to treatment. A confirmatory positron emission tomography (PET) scan could be ordered to confirm CR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

From enrollment until the end of 3+ treatment cycles (each cycle is 21 days), up to 190 days.

Results posted on

2026-05-12

Participant Flow

34 participants with metastatic PDAC were enrolled at 2 sites. 16 participants went on to commence paricalcitol upon attaining stable disease (SD) or progressive disease (PD) on first-line chemotherapy. Data from those 16 patients were analyzed for the purposes of this study.

Participant milestones

Participant milestones
Measure	Paricalcitol (Zemplar) Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paclitaxel Protein Bound Plus Cisplatin Plus Gemcitabine and Paricalcitol for Pancreatic Adenocarcinoma (NABPLAGEMD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paricalcitol (Zemplar) n=16 Participants Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Age, Continuous	60 years n=1512 Participants
Sex: Female, Male Female	7 Participants n=1512 Participants
Sex: Female, Male Male	9 Participants n=1512 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1512 Participants
Race (NIH/OMB) Asian	3 Participants n=1512 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants
Race (NIH/OMB) Black or African American	3 Participants n=1512 Participants
Race (NIH/OMB) White	9 Participants n=1512 Participants
Race (NIH/OMB) More than one race	1 Participants n=1512 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1512 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=1512 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=1512 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=1512 Participants
Region of Enrollment United States	16 participants n=1512 Participants
Karnofsky Performance Status (KPS) 80%	3 Participants n=1512 Participants
Karnofsky Performance Status (KPS) 90%	6 Participants n=1512 Participants
Karnofsky Performance Status (KPS) 100%	7 Participants n=1512 Participants

PRIMARY outcome

Timeframe: From enrollment until the end of 3+ treatment cycles (each cycle is 21 days), up to 190 days.

Outcome measures

Outcome measures
Measure	Paricalcitol (Zemplar) n=14 Participants Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Best Overall Response (BOR) Complete response (CR)	0 Participants
Best Overall Response (BOR) Partial response (PR)	0 Participants
Best Overall Response (BOR) Stable disease (SD)	3 Participants
Best Overall Response (BOR) Progressive disease (PD)	11 Participants

PRIMARY outcome

Timeframe: From start of paricalcitol to disease progression, up to 7 months

Population: n=15 experienced progression and were evaluable for PFS; n=1 participant was progression-free at their last study scan and was censored from this analysis.

Progression-free survival (PFS) is defined as the time from starting paricalcitol until disease progression. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a ≥20% increase in the sum of the longest diameter of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Paricalcitol (Zemplar) n=15 Participants Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Progression-free Survival (PFS)	1.6 Months Interval 1.3 to 2.4

PRIMARY outcome

Timeframe: From start of paricalcitol through follow-up, up to 16.5 months

Overall survival (OS) is defined as the length of time that patients remained alive after starting paricalcitol treatment.

Outcome measures

Outcome measures
Measure	Paricalcitol (Zemplar) n=16 Participants Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Overall Survival (OS)	4.8 Months Interval 2.4 to 10.4

SECONDARY outcome

Timeframe: At the end of each treatment cycle (each cycle is 21 days), up to 30 weeks.

Population: n=13 patients were CA 19-9 expressers and could be included in this analysis. n=3 were not CA 19-9 expressers and excluded from this analysis.

Carbohydrate antigen 19-9 (CA 19-9) is a validated serum biomarker for pancreatic cancer tumor burden used to monitor treatment response. Serum CA19-9 values were measured after each cycle of treatment to identify if they normalized over time. The median beta coefficient (slope of the regression line) among CA 19-9 expressing participants in a linear mixed effects model of log-transformed CA 19-9 is reported here. A positive beta coefficient is associated with increasing CA 19-9 levels over time (higher tumor burden; no treatment response), while a negative beta coefficient is associated with decreasing CA 19-9 levels over time (lower tumor burden; treatment response).

Outcome measures

Outcome measures
Measure	Paricalcitol (Zemplar) n=13 Participants Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Serum Levels of Carbohydrate Antigen 19-9 (CA19-9)	0.057 Beta coefficient Interval 0.042 to 0.072

SECONDARY outcome

Timeframe: From enrollment through 30 days after last paricalcitol treatment, up to 16.5 months

The number of patients who experienced an adverse event (AE) determined to be possibly related to the study treatment of paricalcitol. Adverse events occurring were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the AE and are given on a 1-5 scale, with each scale having unique clinical descriptions of severity for each AE based on this general guideline: * Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. * Grade 2: Moderate; minimal, local or noninvasive intervention indicated * Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling * Grade 4: Life-threatening consequences; urgent intervention indicated. * Grade 5: Death related to AE.

Outcome measures

Outcome measures
Measure	Paricalcitol (Zemplar) n=16 Participants Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Adverse Events Possibly Related to Paricalcitol Anemia · Grade 1-2	0 Participants
Adverse Events Possibly Related to Paricalcitol Anemia · Grade 3-4	1 Participants
Adverse Events Possibly Related to Paricalcitol Anemia · Not Affected	15 Participants
Adverse Events Possibly Related to Paricalcitol Diarrhea · Grade 1-2	1 Participants
Adverse Events Possibly Related to Paricalcitol Diarrhea · Grade 3-4	0 Participants
Adverse Events Possibly Related to Paricalcitol Diarrhea · Not Affected	15 Participants
Adverse Events Possibly Related to Paricalcitol Vomiting · Grade 1-2	1 Participants
Adverse Events Possibly Related to Paricalcitol Vomiting · Grade 3-4	0 Participants
Adverse Events Possibly Related to Paricalcitol Vomiting · Not Affected	15 Participants
Adverse Events Possibly Related to Paricalcitol Fatigue · Grade 1-2	1 Participants
Adverse Events Possibly Related to Paricalcitol Fatigue · Grade 3-4	0 Participants
Adverse Events Possibly Related to Paricalcitol Fatigue · Not Affected	15 Participants
Adverse Events Possibly Related to Paricalcitol Arthralgia · Grade 1-2	1 Participants
Adverse Events Possibly Related to Paricalcitol Arthralgia · Grade 3-4	0 Participants
Adverse Events Possibly Related to Paricalcitol Arthralgia · Not Affected	15 Participants
Adverse Events Possibly Related to Paricalcitol Back pain · Grade 1-2	1 Participants
Adverse Events Possibly Related to Paricalcitol Back pain · Grade 3-4	0 Participants
Adverse Events Possibly Related to Paricalcitol Back pain · Not Affected	15 Participants
Adverse Events Possibly Related to Paricalcitol Lethargy · Grade 1-2	1 Participants
Adverse Events Possibly Related to Paricalcitol Lethargy · Grade 3-4	0 Participants
Adverse Events Possibly Related to Paricalcitol Lethargy · Not Affected	15 Participants
Adverse Events Possibly Related to Paricalcitol Rash · Grade 1-2	1 Participants
Adverse Events Possibly Related to Paricalcitol Rash · Grade 3-4	0 Participants
Adverse Events Possibly Related to Paricalcitol Rash · Not Affected	15 Participants

Adverse Events

Paricalcitol (Zemplar)

Serious events: 7 serious events

Other events: 10 other events

Deaths: 16 deaths

Serious adverse events

Serious adverse events
Measure	Paricalcitol (Zemplar) n=16 participants at risk Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Biliary tract infection	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Pain	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Tumor pain	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Platelet count decreased	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Abdominal pain	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fever	12.5% 2/16 • Number of events 2 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Ascites	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Vascular disorders Flushing	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Other adverse events

Other adverse events
Measure	Paricalcitol (Zemplar) n=16 participants at risk Participants will be treated with the regimen according to the study protocol. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization and undergo imaging to determine response, if any. Paricalcitol (Zemplar): combination therapy
Investigations Aspartate aminotransferase increased	6.2% 1/16 • Number of events 2 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Blood bilirubin increased	6.2% 1/16 • Number of events 2 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Neutrophil count decreased	18.8% 3/16 • Number of events 5 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Investigations Platelet count decreased	12.5% 2/16 • Number of events 8 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Hypoglycemia	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Metabolism and nutrition disorders Vitamin D deficiency	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Musculoskeletal and connective tissue disorders Myalgia	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Lethargy	12.5% 2/16 • Number of events 3 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Nervous system disorders Peripheral sensory neuropathy	25.0% 4/16 • Number of events 4 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Renal and urinary disorders Urine discoloration	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Pruritus	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Skin and subcutaneous tissue disorders Rash	12.5% 2/16 • Number of events 2 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Blood and lymphatic system disorders Anemia	12.5% 2/16 • Number of events 5 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Abdominal pain	31.2% 5/16 • Number of events 5 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Constipation	12.5% 2/16 • Number of events 2 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Diarrhea	12.5% 2/16 • Number of events 3 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Gastrointestinal disorders Vomiting	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Edema limbs	12.5% 2/16 • Number of events 2 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Fatigue	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Gait disturbance	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
General disorders Pain	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations COVID-19	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Infections and infestations Urinary tract infection	18.8% 3/16 • Number of events 3 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Injury, poisoning and procedural complications Fall	6.2% 1/16 • Number of events 1 • From enrollment until 30 days after last dose of study drug, up to 16.5 months Adverse events were collected and graded utilizing the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Additional Information

Erkut Borazanci, MD

HonorHealth Research Institute

Phone: 480-583-7120

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place