Trial Outcomes & Findings for Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer (NCT NCT04524702)
NCT ID: NCT04524702
Last Updated: 2026-01-23
Results Overview
To evaluate the anti-tumor activity of the combination of paricalcitol plus hydroxychloroquine (PH) when added to gemcitabine and nab-paclitaxel treatment by assessing the Overall Response Rate (ORR) by RECIST 1.1. ORR is defined as the percentage of people in the trial who have partial response (PR) or complete response (CR). The Response rate will be estimated with Clopper-Pearson with a 90% exact confidence interval.
COMPLETED
PHASE2
10 participants
At 8 weeks
2026-01-23
Participant Flow
Participant milestones
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Paricalcitol and Hydroxychloroquine in Combination With Gemcitabine and Nab-Paclitaxel for Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=10 Participants
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=270 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=270 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=270 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=270 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=270 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=270 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=270 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=270 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=270 Participants
|
PRIMARY outcome
Timeframe: At 8 weeksTo evaluate the anti-tumor activity of the combination of paricalcitol plus hydroxychloroquine (PH) when added to gemcitabine and nab-paclitaxel treatment by assessing the Overall Response Rate (ORR) by RECIST 1.1. ORR is defined as the percentage of people in the trial who have partial response (PR) or complete response (CR). The Response rate will be estimated with Clopper-Pearson with a 90% exact confidence interval.
Outcome measures
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=7 Participants
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Assessment of Tumor Response to Combination of Paricalcitol and Hydroxychloroquine With Common Front-line Therapy.
|
43 percentage of participants
Interval 10.0 to 82.0
|
SECONDARY outcome
Timeframe: 1 yearToxicities will be presented as worst toxicity per patient and will be reported as percent toxicity. The number of subjects with skipped doses, dose delays and dose reductions as well as major reasons for dose modifications will be summarized. Adverse events will be classified using MedDRA System Organ Classes and Preferred Terms. Furthermore, serious adverse events (SAEs), adverse events (AEs) with a severity grade of 3 or above using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, AEs deemed related to study drug, AEs leading to discontinuation of study drug, and AEs leading to death will also be summarized in preferred term by system organ class and listed on an individual subject basis.
Outcome measures
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=9 Participants
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Incidence of Adverse Events
Action taken after AE, dose interrupted
|
2 Participants
|
|
Incidence of Adverse Events
Action taken after AE, dose decreased
|
0 Participants
|
|
Incidence of Adverse Events
Action taken after AE, No action taken
|
7 Participants
|
|
Incidence of Adverse Events
Action taken after AE, discontinued
|
0 Participants
|
SECONDARY outcome
Timeframe: 32.5 MonthsAssessed using RECIST 1.1. Will be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=10 Participants
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Progression-free Survival
|
6 months
Interval 1.4 to 6.7
|
SECONDARY outcome
Timeframe: 32.5 MonthsWill be estimated using the Kaplan-Meier method.
Outcome measures
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=7 Participants
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Overall Survival
|
6.8 Months
Interval 1.8 to 9.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: blood collection was done at baseline (day -7), cycle 2 day 1.Will evaluate changes in immune and malignant circulating cells before and after treatment with PH when added to gemcitabine and nab-paclitaxel treatment and their relationship.
Outcome measures
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=7 Participants
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Percentage Change in Circulating Pancreatic Ductal Adenocarcinoma Cells
|
50 percentage change in PDAC cells
Standard Deviation 0.5
|
Adverse Events
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
Serious adverse events
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=10 participants at risk
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Renal and urinary disorders
Acute Kidney Injury
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
vomiting
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Generalized Weakness
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
10.0%
1/10 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
Treatment (Paricalcitol, Hydroxychloroquine, Chemotherapy)
n=10 participants at risk
Beginning day -14, patients receive paricalcitol IV three times weekly and hydroxychloroquine PO BID. Patients also receive gemcitabine IV over 30 minutes and nab-paclitaxel IV over 30 minutes on days 1, 8, 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Gemcitabine: Given IV
Hydroxychloroquine: Given PO
Nab-paclitaxel: Given IV
Paricalcitol: Given IV
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
70.0%
7/10 • Number of events 14 • 1 year
|
|
Blood and lymphatic system disorders
anemia
|
70.0%
7/10 • Number of events 40 • 1 year
|
|
Blood and lymphatic system disorders
Thromboembolic Event
|
10.0%
1/10 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
90.0%
9/10 • Number of events 13 • 1 year
|
|
General disorders
Fatigue
|
50.0%
5/10 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
40.0%
4/10 • Number of events 5 • 1 year
|
|
Investigations
Hypercalcemia
|
30.0%
3/10 • Number of events 10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • Number of events 6 • 1 year
|
|
Investigations
Neutropenia
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Investigations
Leukopenia
|
20.0%
2/10 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
3/10 • Number of events 4 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place