Trial Outcomes & Findings for Pre-operative Treatment for Patients With Untreated Pancreatic Cancer (NCT NCT03138720)

Last Updated: 2026-04-22

Results Overview

Laboratory measurements of CA 19-9, a circulating tumor biomarker, were collected after every treatment cycle (approximately 3 weeks/cycle); CA 19-9 normalization after 3 or more treatment cycles was measured.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

From enrollment to the end of treatment, up to 26 weeks.

Results posted on

2026-04-22

Participant Flow

n=8 participants did not meet inclusion/exclusion criteria for the following reasons: High bilirubin (n=2); Metastatic disease (n=3); Normal CA 19-9 (n=1); Normalized CA 19-9 (n=1); Withdrew consent (n=1).

Participant milestones

Participant milestones
Measure	Cohort A: Resectable Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Overall Study STARTED	10	22
Overall Study COMPLETED	10	22
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-operative Treatment for Patients With Untreated Pancreatic Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Total n=32 Participants Total of all reporting groups
Age, Continuous	67 Years n=60 Participants	70.1 Years n=56 Participants	69.4 Years n=116 Participants
Sex: Female, Male Female	6 Participants n=60 Participants	8 Participants n=56 Participants	14 Participants n=116 Participants
Sex: Female, Male Male	4 Participants n=60 Participants	14 Participants n=56 Participants	18 Participants n=116 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=60 Participants	1 Participants n=56 Participants	1 Participants n=116 Participants
Race (NIH/OMB) Asian	1 Participants n=60 Participants	0 Participants n=56 Participants	1 Participants n=116 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants
Race (NIH/OMB) Black or African American	0 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants
Race (NIH/OMB) White	9 Participants n=60 Participants	21 Participants n=56 Participants	30 Participants n=116 Participants
Race (NIH/OMB) More than one race	0 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=60 Participants	2 Participants n=56 Participants	2 Participants n=116 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=60 Participants	20 Participants n=56 Participants	30 Participants n=116 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=60 Participants	0 Participants n=56 Participants	0 Participants n=116 Participants
Region of Enrollment United States	10 Participants n=60 Participants	22 Participants n=56 Participants	32 Participants n=116 Participants
Karnofsky Performance Status (KPS) 100%	3 Participants n=60 Participants	3 Participants n=56 Participants	6 Participants n=116 Participants
Karnofsky Performance Status (KPS) 90%	6 Participants n=60 Participants	9 Participants n=56 Participants	15 Participants n=116 Participants
Karnofsky Performance Status (KPS) 80%	1 Participants n=60 Participants	10 Participants n=56 Participants	11 Participants n=116 Participants
Primary Tumor Site, Pancreas Head	5 Participants n=60 Participants	14 Participants n=56 Participants	19 Participants n=116 Participants
Primary Tumor Site, Pancreas Neck	3 Participants n=60 Participants	6 Participants n=56 Participants	9 Participants n=116 Participants
Primary Tumor Site, Pancreas Body	1 Participants n=60 Participants	2 Participants n=56 Participants	3 Participants n=116 Participants
Primary Tumor Site, Pancreas Tail	1 Participants n=60 Participants	0 Participants n=56 Participants	1 Participants n=116 Participants
Pancreatic Cancer Stage IA	4 Participants n=60 Participants	2 Participants n=56 Participants	6 Participants n=116 Participants
Pancreatic Cancer Stage IB	4 Participants n=60 Participants	8 Participants n=56 Participants	12 Participants n=116 Participants
Pancreatic Cancer Stage IIA	0 Participants n=60 Participants	3 Participants n=56 Participants	3 Participants n=116 Participants
Pancreatic Cancer Stage IIB	2 Participants n=60 Participants	2 Participants n=56 Participants	4 Participants n=116 Participants
Pancreatic Cancer Stage III	0 Participants n=60 Participants	7 Participants n=56 Participants	7 Participants n=116 Participants
CA 19-9	115 U/mL n=60 Participants	312 U/mL n=56 Participants	182 U/mL n=116 Participants

PRIMARY outcome

Timeframe: From enrollment to the end of treatment, up to 26 weeks.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
CA 19-9 Normalization Non-responder (< 50%)	40 Percentage of participants Interval 12.2 to 73.8	13.6 Percentage of participants Interval 2.9 to 34.9
CA 19-9 Normalization Minor responder (50-89%)	30 Percentage of participants Interval 6.7 to 65.2	50 Percentage of participants Interval 28.2 to 71.8
CA 19-9 Normalization Major responder (> 89%)	30 Percentage of participants Interval 6.7 to 65.2	36.4 Percentage of participants Interval 17.2 to 59.3
CA 19-9 Normalization Normalized (< 35 U/mL)	30 Percentage of participants Interval 6.7 to 65.2	50 Percentage of participants Interval 28.2 to 71.8

SECONDARY outcome

Timeframe: From enrollment to the end of treatment, up to 26 weeks.

Population: Only a subset of participants underwent tumor surgical resection.

The percentage of participants whose tumors could be completely removed by surgery with no cancer cells left at margins (R0).

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Resectability Rate (R0) All Participants	90 Percentage of participants Interval 55.5 to 99.7	45.5 Percentage of participants Interval 24.4 to 67.8
Resectability Rate (R0) Participants Who Underwent Surgery	100 Percentage of participants Interval 66.4 to 100.0	90.9 Percentage of participants Interval 58.7 to 99.8

SECONDARY outcome

Timeframe: From enrollment to end of treatment, up to 26 weeks.

Population: Row "Participants Who Underwent Surgery" highlights pCR for the subset of patients who underwent surgical resection of their primary tumor.

Participants received a CT/MRI scan after completing treatment cycles 3, 6, 9 to evaluate disease status using same imaging method as Baseline. RECIST 1.1 criteria were used to evaluate response. A confirmatory PET scan may have been ordered to confirm complete response.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Pathologic Complete Response Rate (pCR) All Participants	0 Percentage of participants Interval 0.0 to 30.8	9.1 Percentage of participants Interval 1.1 to 29.2
Pathologic Complete Response Rate (pCR) Participants Who Underwent Surgery	0.0 Percentage of participants Interval 0.0 to 33.6	18.2 Percentage of participants Interval 2.3 to 51.8

SECONDARY outcome

Timeframe: From enrollment to the end of treatment, up to 26 weeks.

Population: Radiologic response was not available for n=4 participants.

Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria. Complete Response (CR; all tumors disappeared), Partial Response (PR; \>30% decrease in tumor size), Stable Disease (SD; no change), and Progressive Disease (PD; \>20% increase in tumor size or new lesions).

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=8 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=20 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Radiological Response - All Responses Complete Response (CR)	0 Participants	1 Participants
Radiological Response - All Responses Partial Response (PR)	2 Participants	8 Participants
Radiological Response - All Responses Stable Disease (SD)	6 Participants	11 Participants

SECONDARY outcome

Timeframe: From enrollment to the end of treatment, up to 26 weeks.

Population: Radiological response was not available for n=4 participants.

Objective measurement of changes in tumor size upon imaging after treatment per RECIST v1.1 criteria; percentage of participants reporting Complete Response (CR; all tumors disappear) and Partial Response (PR; \>30% decrease in tumor size).

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=8 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=20 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Radiological Response - Complete Response (CR) or Partial Response (PR)	25 Percentage of participants Interval 3.2 to 65.1	45 Percentage of participants Interval 23.1 to 68.5

SECONDARY outcome

Timeframe: every 12 weeks after study completion

Participants were contacted by telephone every 12 weeks to monitor survival until date of death.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Overall Survival	43.2 Months Interval 7.5 to Upper bound confidence interval could not be calculated due to insufficient event occurrence in this group.	18.4 Months Interval 10.9 to 41.2

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to end of study, up to 26 weeks.

The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain severity was assessed with a scale range of 0-10, 0=no pain, 10=worst imaginable. Multiple question results were combined into a single pain severity score per patient on the 0-10 scale range.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score Baseline	0.0 BPI Pain Severity Score Interval 0.0 to 2.8	2 BPI Pain Severity Score Interval 0.2 to 4.0
Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score End of Treatment (EOT)	0.2 BPI Pain Severity Score Interval 0.0 to 0.8	0.4 BPI Pain Severity Score Interval 0.0 to 2.2
Quality of Life - Brief Pain Inventory (BPI), Pain Severity Score Change Between Baseline and EOT	0.0 BPI Pain Severity Score Interval 0.0 to 0.5	0.0 BPI Pain Severity Score Interval -2.5 to 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment through end of study, up to 26 weeks.

The Brief Pain Inventory (BPI) is a standard questionnaire administered to participants to measure cancer pain intensity and the impact of pain on daily life in the past 24 hours. Pain interference was assessed with a scale range of 0-10, 0=does not interfere, 10=completely interferes. Multiple question results were combined into a single pain interference score per patient on the 0-10 scale range.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score End of Treatment (EOT)	0.0 BPI Pain Interference Score Interval 0.0 to 0.4	0.6 BPI Pain Interference Score Interval 0.0 to 3.3
Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score Baseline	0.0 BPI Pain Interference Score Interval 0.0 to 0.0	1.3 BPI Pain Interference Score Interval 0.3 to 3.4
Quality of Life - Brief Pain Inventory (BPI), Pain Interference Score Change Between Baseline and EOT	0.0 BPI Pain Interference Score Interval 0.0 to 0.1	-0.3 BPI Pain Interference Score Interval -2.0 to 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to end of study, up to 26 weeks.

The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Core symptom severity within the last 24 hours was assessed with a scale range of 0-10, 0=not present, 10=worst imaginable. The reported severity of multiple symptoms was combined into a single overall symptom severity score for each patient on the 0-10 scale range.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score End of Treatment (EOT)	0.8 MDASI-GI Symptom Severity Score Interval 0.1 to 2.2	1.2 MDASI-GI Symptom Severity Score Interval 0.7 to 2.2
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score Change Between Baseline and EOT	0.1 MDASI-GI Symptom Severity Score Interval -0.2 to 0.7	0.0 MDASI-GI Symptom Severity Score Interval -1.2 to 1.0
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Core Symptom Severity Score Baseline	1.2 MDASI-GI Symptom Severity Score Interval 0.0 to 1.8	1.6 MDASI-GI Symptom Severity Score Interval 0.0 to 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to end of study, up to 26 weeks.

The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. The GI module asks specific questions related to GI symptoms and asks users to rank the severity of symptoms using a 0-10 scale, 0=not present, 10=worst imaginable. The reported severity of multiple GI symptoms was combined into a single GI module score for each patient on the 0-10 scale range.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), GI Module Score Baseline	0.6 MDASI-GI GI Module Score Interval 0.0 to 1.0	0.8 MDASI-GI GI Module Score Interval 0.2 to 1.6
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), GI Module Score End of Treatment (EOT)	1 MDASI-GI GI Module Score Interval 0.0 to 1.8	0.7 MDASI-GI GI Module Score Interval 0.2 to 1.2
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), GI Module Score Change Between Baseline and EOT	0.1 MDASI-GI GI Module Score Interval 0.0 to 0.6	-0.2 MDASI-GI GI Module Score Interval -1.4 to 0.2

OTHER_PRE_SPECIFIED outcome

Timeframe: From enrollment to end of study, up to 26 weeks.

The MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI) is a questionnaire designed to assess the severity and impact of cancer symptoms on daily life activities. Symptom interference with daily life activities within the last 24 hours was measured using a 0-10 scale, 0=does not interfere, 10=interferes completely. The reported interference for multiple daily activities was combined into a single symptom interference score for each patient on the 0-10 scale range.

Outcome measures

Outcome measures
Measure	Cohort A: Resectable n=10 Participants Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 Participants Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Overall Symptom Interference With Daily Life Score Baseline	0.8 MDASI-GI Symptom Interference Score Interval 0.0 to 2.2	0.8 MDASI-GI Symptom Interference Score Interval 0.0 to 3.8
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Overall Symptom Interference With Daily Life Score End of Treatment (EOT)	1.3 MDASI-GI Symptom Interference Score Interval 0.0 to 4.3	0.8 MDASI-GI Symptom Interference Score Interval 0.0 to 3.0
Quality of Life - MD Anderson Symptom Inventory for Gastrointestinal Cancer (MDASI-GI), Overall Symptom Interference With Daily Life Score Change Between Baseline and EOT	0.6 MDASI-GI Symptom Interference Score Interval 0.0 to 2.0	-0.5 MDASI-GI Symptom Interference Score Interval -1.0 to 1.0

Adverse Events

Cohort A: Resectable

Serious events: 3 serious events

Other events: 10 other events

Deaths: 3 deaths

Cohort B: Borderline Resectable/Locally Advanced (Unresectable)

Serious events: 11 serious events

Other events: 22 other events

Deaths: 14 deaths

Serious adverse events

Other adverse events

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

Measure	Cohort A: Resectable n=10 participants at risk Participants with resectable pancreatic cancer were assigned to Cohort A (see Protocol for definition of resectable pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.	Cohort B: Borderline Resectable/Locally Advanced (Unresectable) n=22 participants at risk Participants with borderline resectable/locally advanced (unresectable) pancreatic cancer were assigned to Cohort B (see Protocol for definitions of borderline resectable/locally advanced (unresectable) pancreatic cancer). Participants were offered up to 6 months neoadjuvant therapy as follows: Paclitaxel protein bound 125 mg/m2 over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Cisplatin 25 mg/m2 in 500 mL of 0.9% Sodium Chloride Injection over 60 minute IV infusion on days 1 and 8, repeated every 21 days; Gemcitabine 1000 mg/m2 in 250 mL 0.9% Sodium Chloride Injection over 30 minute IV infusion on days 1 and 8 repeated every 21 days; Paricalcitol given at a dose of 25 micrograms days 1 and 8 and 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. This could start at the same time as the gemcitabine infusion. Participants whose CA19-9 levels normalized during the above neoadjuvant therapy were re-evaluated for surgery and removed from study for surgical resection if determined eligible.
Investigations Blood Antidiuretic Hormone Abnormal	10.0% 1/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Nervous system disorders Stroke	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Gastrointestinal disorders Constipation	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Hepatobiliary disorders Other - Biliary Obstruction	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Infections and infestations Biliary Tract Infection	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Injury, poisoning and procedural complications Ankle Fracture	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Infections and infestations Sepsis	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Gastrointestinal disorders Diarrhea	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Gastrointestinal disorders Duodenal Hemorrhage	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	9.1% 2/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Gastrointestinal disorders Pancreatic Necrosis	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Infections and infestations Appendicitis Perforated	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
General disorders Fever	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Hepatobiliary disorders Cholecystitis	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Infections and infestations Other - Cellulitis	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Hepatobiliary disorders Biliary Fistula	0.00% 0/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	4.5% 1/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Gastrointestinal disorders Anal Pain	10.0% 1/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	0.00% 0/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
Blood and lymphatic system disorders Anemia	10.0% 1/10 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).	0.00% 0/22 • From enrollment until end of treatment, up to 26 weeks. Adverse events occurring during the study were graded according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).