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Pre-Operative Trial (PGHA vs. PGH) for Resectable Pancreatic Cancer (17-134)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03344172
Recruitment Status : Terminated (Suspected Serious Adverse Events related to treatment)
First Posted : November 17, 2017
Results First Posted : May 14, 2020
Last Update Posted : May 14, 2020
Sponsor:
Collaborators:
Pfizer
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nathan Bahary, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer Resectable
Interventions Drug: Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab
Drug: Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Period Title: Overall Study
Started 16 16
Completed 15 16
Not Completed 1 0
Reason Not Completed
Received <1 dose of treatment             1             0
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine Total
Hide Arm/Group Description

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
Participants that received at least one cycle/dose of study treatment.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Safety cohort Number Analyzed 15 participants 16 participants 31 participants
64.4  (6.5) 69.9  (9.8) 67.0  (8.7)
Efficacy cohort Number Analyzed 8 participants 10 participants 18 participants
62.2  (6.4) 65.6  (9.7) 64.1  (8.3)
[1]
Measure Analysis Population Description: The Safety Cohort includes the 31 participants who received at least one dose. The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Safety cohort Number Analyzed 15 participants 16 participants 31 participants
Female
6
  40.0%
7
  43.8%
13
  41.9%
Male
9
  60.0%
9
  56.3%
18
  58.1%
Efficacy cohort Number Analyzed 8 participants 10 participants 18 participants
Female
3
  37.5%
5
  50.0%
8
  44.4%
Male
5
  62.5%
5
  50.0%
10
  55.6%
[1]
Measure Analysis Population Description:

The Safety cohort includes the 31 participants who received at least one dose.

The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.

Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Safety cohort Number Analyzed 15 participants 16 participants 31 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
15
 100.0%
16
 100.0%
31
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Efficacy cohort Number Analyzed 8 participants 10 participants 18 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
8
 100.0%
10
 100.0%
18
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Analysis Population Description: The Safety cohort includes the 31 participants who received at least one dose. The Efficacy cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
Karnofsky Performance Status - Safety Cohort   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 16 participants 30 participants
Safety Cohort - Karnofsky Score of 90
6
  42.9%
3
  18.8%
9
  30.0%
Safety Cohort - Karnofsky Score of 100
8
  57.1%
13
  81.3%
21
  70.0%
[1]
Measure Description: The Karnofsky Performance Scale Index is an assessment tool for functional impairment used to compare effectiveness of therapy and to assess the prognosis in individual patients. It consists of a comprehensive 11-point scale correlating to percentage values ranging from 100% (no evidence of disease, no symptoms) to 0% (death). Lower Karnofsky scores are associated with a poorer prognosis.
[2]
Measure Analysis Population Description: The Safety Cohort includes the 31 participants who received at least one dose.
Karnofsky Performance Status - Efficacy Cohort   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 10 participants 17 participants
Efficacy Cohort - Karnofsky Score of 90
4
  57.1%
1
  10.0%
5
  29.4%
Efficacy Cohort - Karnofsky Score of 100
3
  42.9%
9
  90.0%
12
  70.6%
[1]
Measure Description: Measure Description: The Karnofsky Performance Scale Index is an assessment tool for functional impairment used to compare effectiveness of therapy and to assess the prognosis in individual patients. It consists of a comprehensive 11-point scale correlating to percentage values ranging from 100% (no evidence of disease, no symptoms) to 0% (death). Lower Karnofsky scores are associated with a poorer prognosis.
[2]
Measure Analysis Population Description: The Efficacy Cohort includes 18 of the 31 participants who received at least one dose, who underwent surgery.
1.Primary Outcome
Title Proportion of Grade IIb or Higher Histolopathologic Responses
Hide Description Number of grade IIb+lll+lllm+IV+lVm responses / total number of all grade histolopathologic responses. Histoligic appearance will be assess per the Grading System for Pathological Response: Grade I - Characteristic cytologic changes of malignancy present, but little (< 10%) or no tumor cell destruction is evident; Grade II - Characteristic cytologic changes of malignancy; 10% to 90% of tumor cells are destroyed; Grade IIa - Destruction of 10% to 50% of tumor cells; Grade IIb - Destruction of 51% to 90% of tumor cells; Grade III - Few (< 10%) viable-appearing tumor cells are present; Grade IIIm - Sizable pools of mucin present; Grade IV - No viable tumor cells present; Grade IVm - Acellular pools of mucin present.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received at least one cycle/dose of study treatment for whom tissue samples were available for histological evaluation using the Grading System for Pathological Response.
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description:

Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Day 1 of Cycle 3: avelumab (10mg/kg)

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Overall Number of Participants Analyzed 6 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33.3
(4.3 to 77.7)
50.0
(18.7 to 81.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab, PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.30 to 6.71
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change in CA19-9 Levels
Hide Description Levels of CA19-9 (tumor marker) in preoperative and postoperative tissues will be determined. Higher levels of CA19-9 are associated with progressive disease.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received at least one cycle/dose of study treatment for whom tissue samples were available for analysis.
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description:

Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Day 1 of Cycle 3: avelumab (10mg/kg)

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Overall Number of Participants Analyzed 5 5
Mean (95% Confidence Interval)
Unit of Measure: units per milliliter (U/mL)
-0.37
(-0.87 to 0.13)
-0.88
(-1.54 to -0.22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab, PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.63
Confidence Interval (2-Sided) 95%
-1.00 to -0.25
Parameter Dispersion
Type: Standard Deviation
Value: 0.52
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Worst Grade of Adverse Event Experienced At Least Possibly Related to Treatment
Hide Description Percentage of participants that experienced an adverse event at least possibly related to study treatment, by Grade. Adverse events were evaluated per per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received at least one cycle/dose of study treatment.
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description:

Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Day 1 of Cycle 3: avelumab (10mg/kg)

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Overall Number of Participants Analyzed 15 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percetage of participants
Grade 1
6.7
(0.5 to 49.6)
6.3
(0.5 to 47.8)
Grade 2
40.0
(12.0 to 76.4)
18.8
(3.5 to 59.6)
Grade 3
40.0
(12.0 to 76.4)
62.5
(26.0 to 88.8)
Grade 4
6.7
(5.1 to 49.6)
0.0
(0.0 to 40.9)
Grade 5
6.7
(5.1 to 49.6)
6.3
(0.5 to 47.8)
No Adverse Events
0.0
(0.0 to 52.5)
6.3
(0.5 to 47.8)
4.Secondary Outcome
Title Worst Grade of Adverse Event Experienced At Least Probably Related to Treatment
Hide Description Percentage of participants that experienced an adverse event at least probably related to study treatment, by Grade. Adverse events were evaluated per per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time Frame Up to 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants that received at least one cycle/dose of study treatment.
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description:

Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Day 1 of Cycle 3: avelumab (10mg/kg)

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Overall Number of Participants Analyzed 15 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Grade 1
13.3
(1.8 to 56.0)
12.5
(1.7 to 54.0)
Grade 2
33.3
(8.9 to 71.9)
18.8
(3.5 to 59.6)
Grade 3
33.3
(8.9 to 71.9)
43.3
(14.5 to 78.1)
Grade 4
0.0
(0.0 to 42.4)
0.0
(0.0 to 40.9)
Grade 5
0.0
(0.0 to 42.4)
0.0
(0.0 to 40.9)
No Adverse Events
20.0
(3.7 to 61.8)
25.0
(0.6 to 64.7)
5.Secondary Outcome
Title Autophagy Biomarker Levels by Histopathological Response
Hide Description Autophagy biomarker levels in blood by histopathological response (per the Grading System for Pathological Response)
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Collected specimens will not be run/analyzed due to lack of funding.
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description:

Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Day 1 of Cycle 3: avelumab (10mg/kg)

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Change in Coagulation Index (CI)
Hide Description Comparison of the preoperative and postoperative Thromboelastogram (TEG) Coagulation Index (CI) profile. TEG is an overall assessment of coagulability, quantitatively measures the ability of whole blood to form a clot. Cancer patients are at greater risk for thromboembolism compared to the normal population due to tumor burden and systemic therapies.
Time Frame up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Collected specimens will not be run/analyzed due to lack of funding.
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description:

Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Day 1 of Cycle 3: avelumab (10mg/kg)

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Up to 6 months per participant; 18 months for each cohort
Adverse Event Reporting Description

All adverse events were graded according to the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0.

Serious Adverse Events included only events of Grade 3 or greater.

 
Arm/Group Title PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Hide Arm/Group Description

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine and Avelumab

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2)

Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine

Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery

All-Cause Mortality
PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Affected / at Risk (%) Affected / at Risk (%)
Total   1/15 (6.67%)      1/16 (6.25%)    
Hide Serious Adverse Events
PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/15 (60.00%)      12/16 (75.00%)    
Blood and lymphatic system disorders     
Anemia  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Febrile neutropenia  1  1/15 (6.67%)  8 0/16 (0.00%)  0
Leukocytosis  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Cardiac disorders     
Cardiac arrest  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Nausea  1  2/15 (13.33%)  8 0/16 (0.00%)  0
General disorders     
Fatigue  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Fever  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Infections and infestations     
Biliary tract infection  1  1/15 (6.67%)  4 1/16 (6.25%)  3
Infections and infestations - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Salivary gland infection  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  0/15 (0.00%)  0 1/16 (6.25%)  4
Investigations     
Alanine aminotransferase increased  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Lymphocyte count decreased  1  2/15 (13.33%)  8 1/16 (6.25%)  3
Neutrophil count decreased  1  3/15 (20.00%)  12 4/16 (25.00%)  18
White blood cell decreased  1  2/15 (13.33%)  8 1/16 (6.25%)  3
Metabolism and nutrition disorders     
Anorexia  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Dehydration  1  1/15 (6.67%)  4 2/16 (12.50%)  7
Hypokalemia  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Hyponatremia  1  1/15 (6.67%)  4 3/16 (18.75%)  9
Hypophosphatemia  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Skin and subcutaneous tissue disorders     
Rash maculo-papular  1  2/15 (13.33%)  8 2/16 (12.50%)  6
Skin and subcutaneous tissue disorders - Other, specify  1  2/15 (13.33%)  8 0/16 (0.00%)  0
Vascular disorders     
Hypertension  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Hypotension  1  1/15 (6.67%)  4 1/16 (6.25%)  3
Thromboembolic event  1  1/15 (6.67%)  4 0/16 (0.00%)  0
1
Term from vocabulary, CTCAE (v4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PGHA: Gemcitabine, Nab-Paclitaxel, Hydroxychloroquine+Avelumab PGH: Gemcitabine, Nab-Paclitaxel, and Hydroxychloroquine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      15/16 (93.75%)    
Blood and lymphatic system disorders     
Anemia  1  10/15 (66.67%)  60 11/16 (68.75%)  51
Febrile neutropenia  1  1/15 (6.67%)  8 0/16 (0.00%)  0
Leukocytosis  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Cardiac disorders     
Cardiac arrest  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Cardiac disorders - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Sinus bradycardia  1  2/15 (13.33%)  16 0/16 (0.00%)  0
Endocrine disorders     
Endocrine disorders - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Eye disorders     
Blurred vision  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Gastrointestinal disorders     
Abdominal pain  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Colitis  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Constipation  1  2/15 (13.33%)  8 1/16 (6.25%)  3
Diarrhea  1  6/15 (40.00%)  24 4/16 (25.00%)  12
Gastroesophageal reflux disease  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Gastrointestinal disorders - Other, specify  1  3/15 (20.00%)  12 0/16 (0.00%)  0
Mucositis oral  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Nausea  1  9/15 (60.00%)  40 4/16 (25.00%)  15
Rectal hemorrhage  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Vomiting  1  5/15 (33.33%)  24 1/16 (6.25%)  6
General disorders     
Chills  1  3/15 (20.00%)  12 0/16 (0.00%)  0
Edema limbs  1  1/15 (6.67%)  4 2/16 (12.50%)  6
Fatigue  1  5/15 (33.33%)  20 7/16 (43.75%)  30
Fever  1  7/15 (46.67%)  36 0/16 (0.00%)  0
Hypothermia  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Infusion related reaction  1  3/15 (20.00%)  12 0/16 (0.00%)  0
Pain  1  2/15 (13.33%)  8 3/16 (18.75%)  9
Hepatobiliary disorders     
Hepatobiliary disorders - Other, specify  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Infections and infestations     
Biliary tract infection  1  1/15 (6.67%)  4 1/16 (6.25%)  3
Infections and infestations - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Salivary gland infection  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  0/15 (0.00%)  0 1/16 (6.25%)  4
Investigations     
Alanine aminotransferase increased  1  9/15 (60.00%)  64 4/16 (25.00%)  12
Alkaline phosphatase increased  1  6/15 (40.00%)  40 3/16 (18.75%)  12
Aspartate aminotransferase increased  1  10/15 (66.67%)  60 5/16 (31.25%)  15
Blood bilirubin increased  1  1/15 (6.67%)  4 0/16 (0.00%)  0
CPK increased  1  4/15 (26.67%)  20 1/16 (6.25%)  3
Creatinine increased  1  1/15 (6.67%)  12 1/16 (6.25%)  6
Lipase increased  1  2/15 (13.33%)  12 4/16 (25.00%)  12
Lymphocyte count decreased  1  5/15 (33.33%)  32 2/16 (12.50%)  12
Neutrophil count decreased  1  9/15 (60.00%)  64 6/16 (37.50%)  39
Platelet count decreased  1  8/15 (53.33%)  40 13/16 (81.25%)  57
Serum amylase increased  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Weight loss  1  0/15 (0.00%)  0 3/16 (18.75%)  9
White blood cell decreased  1  9/15 (60.00%)  60 9/16 (56.25%)  48
Metabolism and nutrition disorders     
Anorexia  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Dehydration  1  1/15 (6.67%)  4 3/16 (18.75%)  10
Hypercalcemia  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Hyperglycemia  1  1/15 (6.67%)  4 1/16 (6.25%)  3
Hypoalbuminemia  1  5/15 (33.33%)  40 6/16 (37.50%)  33
Hypocalcemia  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Hypokalemia  1  3/15 (20.00%)  24 5/16 (31.25%)  21
Hypomagnesemia  1  3/15 (20.00%)  20 1/16 (6.25%)  3
Hyponatremia  1  7/15 (46.67%)  48 8/16 (50.00%)  42
Hypophosphatemia  1  1/15 (6.67%)  4 2/16 (12.50%)  9
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Generalized muscle weakness  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Nervous system disorders     
Dizziness  1  2/15 (13.33%)  8 0/16 (0.00%)  0
Dysgeusia  1  1/15 (6.67%)  4 1/16 (6.25%)  3
Lethargy  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Nervous system disorders - Other, specify  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Psychiatric disorders     
Anxiety  1  1/15 (6.67%)  8 0/16 (0.00%)  0
Insomnia  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Restlessness  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis  1  0/15 (0.00%)  0 1/16 (6.25%)  6
Cough  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Epistaxis  1  0/15 (0.00%)  0 2/16 (12.50%)  6
Nasal congestion  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Skin and subcutaneous tissue disorders     
Alopecia  1  0/15 (0.00%)  0 1/16 (6.25%)  6
Dry skin  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Pruritus  1  1/15 (6.67%)  4 0/16 (0.00%)  0
Purpura  1  0/15 (0.00%)  0 1/16 (6.25%)  3
Rash maculo-papular  1  5/15 (33.33%)  20 3/16 (18.75%)  12
Skin and subcutaneous tissue disorders - Other, specify  1  5/15 (33.33%)  36 1/16 (6.25%)  3
Vascular disorders     
Hypertension  1  1/15 (6.67%)  4 2/16 (12.50%)  15
Hypotension  1  1/15 (6.67%)  12 2/16 (12.50%)  6
Thromboembolic event  1  1/15 (6.67%)  4 0/16 (0.00%)  0
1
Term from vocabulary, CTCAE (v4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Barbara Stadterman, MPH, MCCR; CRS Regulatory Supervisor
Organization: UPMC Hillman Cancer Center
Phone: 412-647-5554
EMail: stadtermanbm@upmc.edu
Layout table for additonal information
Responsible Party: Nathan Bahary, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03344172    
Other Study ID Numbers: HCC# 17-134
R01CA181450 ( U.S. NIH Grant/Contract )
First Submitted: October 3, 2017
First Posted: November 17, 2017
Results First Submitted: April 30, 2020
Results First Posted: May 14, 2020
Last Update Posted: May 14, 2020