Trial Outcomes & Findings for Study of Pre-surgery Gemcitabine + Hydroxychloroquine (GcHc) in Stage IIb or III Adenocarcinoma of the Pancreas (NCT NCT01128296)
NCT ID: NCT01128296
Last Updated: 2019-05-01
Results Overview
Number of Participants at each dose level of HCQ that experienced a Dose Limiting Toxicity (DLT).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to 31 days
Results posted on
2019-05-01
Participant Flow
35 enrolled 2 participants withdrew prior to treatment 1 participants removed from protocol after the first dose of gemcitabine due to cerebrovascular accident unrelated to study drug 1 patient removed from protocol due to allergic rash likely related to gemcitabine 31 participants remained to receive gemcitabine + HCQ treatment
Participant milestones
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
26
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
5
|
Reasons for withdrawal
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Study of Pre-surgery Gemcitabine + Hydroxychloroquine (GcHc) in Stage IIb or III Adenocarcinoma of the Pancreas
Baseline characteristics by cohort
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)
n=31 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
|
|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 31 daysPopulation: Observed for dose-limiting toxicities or treatment delays attributed to HCQ to determine the maximum tolerated dose.
Number of Participants at each dose level of HCQ that experienced a Dose Limiting Toxicity (DLT).
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=1 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
n=1 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
n=1 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
n=1 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
n=1 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
n=26 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Number of Participants That Experienced a Dose Limiting Toxicity (DLT)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Participants that completed more than 80 % of the intended dose of HCQ.
Median number of months of disease-free survival for participants receiving study treatment.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=31 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival (DFS)
|
11.97 months
Interval 7.27 to 22.43
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: Participants that completed more than 80% of the intended dose of HCQ.
Median number of months of overall survival for participants receiving study treatment.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=31 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
34.83 months
Interval 11.57 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Subset of participants that completed more than 80% of the intended dose of HCQ treatment.
Median number of months of disease-free survival in participants who did and did not experience response to HCQ treatment. Patients who had \>51 % increase in their LC3-II staining were classified as having a response to HCQ.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=17 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival (DFS) by Response to HCQ Treatment
Response to HQC treatment
|
15.03 months
Interval 6.8 to
Upper bound not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
|
Disease-free Survival (DFS) by Response to HCQ Treatment
No response to HQC treatment
|
6.9 months
Interval 0.2 to
Upper bound not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: Subset of participants that completed more than 80 % of the intended dose of HCQ.
Median number of months of overall survival in participants who did and did not experience response to HCQ treatment. Patients who had \>51 % increase in their LC3-II staining were classified as having a response to HCQ.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=17 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) by Response to HCQ Treatment
Response to HQC treatment
|
34.83 months
Interval 11.7 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS) by Response to HCQ Treatment
No response to HQC treatment
|
10.83 months
Interval 0.02 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Participants that completed more than 80 % of the intended dose of HCQ.
Number of participants that underwent a resection with microscopically margin-negative resection in which no gross or microscopic tumor remains in the primary tumor bed (24) / number of that completed treatment (31)
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=31 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
R0 Resection Rate
|
77 percentage of participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Analysis population included a total of 26 participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response.
Median number of months of disease-free survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from \>0 to 225%. Per participant decreases in Ca 19-9 ranged from \>0 to 100%.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=26 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival (DFS) by CA 19-9 Response
Ca 19-9 Response
|
21.4 months
Interval 9.1 to 24.2
|
—
|
—
|
—
|
—
|
—
|
|
Disease-free Survival (DFS) by CA 19-9 Response
No Ca 19-9 Response
|
6.9 months
Interval 2.3 to 9.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: Analysis population included participants who received study treatment, who experienced either an increase or decrease in Ca 19-9, or no Ca 19-9 surrogate biomarker response
Median number of months of overall survival for participants who experienced Ca 19-9 (surrogate biomarker) response (either an increase or decrease in Ca 19-9), or, no Ca 19-9 response. Per participant increases in Ca 19-9 ranged from \>0 to 225%. Per participant decreases in Ca 19-9 ranged from \>0 to 100%.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=26 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) by CA 19-9 Response
Ca 19-9 Response (increase or decrease)
|
34.8 months
Interval 11.7 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS) by CA 19-9 Response
No Ca 19-9 Response
|
8.8 months
Interval 5.6 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: Participants that completed more than 80 % of the intended dose of HCQ.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=31 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Disease-free Survival by p53 Genetic Status
p53 WT
|
21.4 months
Interval 5.5 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
|
Disease-free Survival by p53 Genetic Status
p53 Mutant
|
11.8 months
Interval 6.9 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 35 monthsPopulation: Participants that completed more than 80 % of the intended dose of HCQ.
Outcome measures
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (200 mg/Day)
n=31 Participants
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 200 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (400 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 400 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (600 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 600 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (800 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 800 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1000 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1000 mg/day taken for 31 consecutive days until the day of surgery.
|
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (1200 mg/Day)
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ dose of 1200 mg/day taken for 31 consecutive days until the day of surgery.
|
|---|---|---|---|---|---|---|
|
Overall Survival (OS) by p53 Mutant Status
p53 WT
|
NA months
Interval 5.5 to
Median and Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
|
Overall Survival (OS) by p53 Mutant Status
p53 Mutant
|
26.1 months
Interval 8.8 to
Upper bound of CI not reached due to too few events.
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)
n=35 participants at risk
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
|
|---|---|
|
Infections and infestations
Infection with Grade 3-4 neutrophils (ANC <1.0x10^9/L), Abdomen NOS
|
2.9%
1/35
|
|
Infections and infestations
Infection with Grade 3-4 neutrophils (ANC <1.0x10^9/L), Biliary tree
|
2.9%
1/35
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS
|
2.9%
1/35
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.9%
1/35
|
Other adverse events
| Measure |
Preoperative Gemcitabine (1500 mg/m^2) + HCQ (≤1200 mg/Day)
n=35 participants at risk
Participants wtih pancreatic adenocarcinoma treated with two doses of fixed dose gemcitabine (1500 mg/m\^2) administered (study days 3 and 17) in combination with oral HCQ (maximum dose of 1200 mg/day) taken for 31 consecutive days until the day of surgery.
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
17.1%
6/35
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
17.1%
6/35
|
|
Blood and lymphatic system disorders
Platelets
|
28.6%
10/35
|
|
Blood and lymphatic system disorders
Hemoglobin
|
65.7%
23/35
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
5.7%
2/35
|
|
General disorders
Weight loss
|
5.7%
2/35
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
37.1%
13/35
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
5.7%
2/35
|
|
Skin and subcutaneous tissue disorders
Rash: acne/acneiform
|
5.7%
2/35
|
|
Skin and subcutaneous tissue disorders
Rash: dermatitis associated with radiation, Chemoradiation
|
11.4%
4/35
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other (Specify, __)
|
14.3%
5/35
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
5.7%
2/35
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
5.7%
2/35
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35
|
|
Gastrointestinal disorders
Anorexia
|
8.6%
3/35
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
5/35
|
|
Gastrointestinal disorders
Constipation
|
17.1%
6/35
|
|
Gastrointestinal disorders
Nausea
|
48.6%
17/35
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other (Specify, __)
|
5.7%
2/35
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
5.7%
2/35
|
|
Metabolism and nutrition disorders
Creatinine
|
5.7%
2/35
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
5.7%
2/35
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
5.7%
2/35
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
8.6%
3/35
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
11.4%
4/35
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
17.1%
6/35
|
|
Metabolism and nutrition disorders
Alkaline phosphatase
|
25.7%
9/35
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase)
|
31.4%
11/35
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
34.3%
12/35
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
40.0%
14/35
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
48.6%
17/35
|
|
Nervous system disorders
Mood alteration, Anxiety
|
5.7%
2/35
|
|
General disorders
Pain - Other (Specify, __)
|
5.7%
2/35
|
|
General disorders
Pain, Abdomen NOS
|
11.4%
4/35
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place