Trial Outcomes & Findings for Minocycline Study in Pancreatic Cancer Patients (NCT NCT01693523)
NCT ID: NCT01693523
Last Updated: 2020-03-09
Results Overview
Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0\*70) to 700 (10\*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
80 participants
Primary outcome timeframe
AUC from baseline to 2 weeks
Results posted on
2020-03-09
Participant Flow
Recruitment period: February 20, 2013 to October, 20 2015. All recruitment done at the University of Texas MD Anderson Cancer
Of the 80 participants enrolled 1 participant were excluded from the study before assignment to groups.
Participant milestones
| Measure |
Minocycline
Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Minocycline: 100 mg by mouth two times a day (200 mg/day).
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Placebo
Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Placebo: Matching placebo capsules by mouth twice a day.
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Observational
No Intervention
|
|---|---|---|---|
|
Overall Study
STARTED
|
23
|
21
|
35
|
|
Overall Study
COMPLETED
|
18
|
13
|
27
|
|
Overall Study
NOT COMPLETED
|
5
|
8
|
8
|
Reasons for withdrawal
| Measure |
Minocycline
Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Minocycline: 100 mg by mouth two times a day (200 mg/day).
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Placebo
Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Placebo: Matching placebo capsules by mouth twice a day.
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Observational
No Intervention
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
1
|
0
|
|
Overall Study
Death
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
4
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
2
|
|
Overall Study
Lack of compliance study medication
|
1
|
2
|
0
|
|
Overall Study
Chemotherapy was held
|
1
|
2
|
0
|
Baseline Characteristics
Minocycline Study in Pancreatic Cancer Patients
Baseline characteristics by cohort
| Measure |
Minocycline
n=23 Participants
Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Minocycline: 100 mg by mouth two times a day (200 mg/day).
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Placebo
n=21 Participants
Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Placebo: Matching placebo capsules by mouth twice a day.
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Observational
n=35 Participants
Non Intervention
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
49 Participants
n=157 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
30 Participants
n=157 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
35 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
44 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
70 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
11 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
65 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=99 Participants
|
21 participants
n=107 Participants
|
35 participants
n=206 Participants
|
79 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: AUC from baseline to 2 weeksPopulation: Of the 44 randomized patients, 30 (68% were evaluable for the primary efficacy analysis).
Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0\*70) to 700 (10\*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.
Outcome measures
| Measure |
Minocycline
n=23 Participants
Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Minocycline: 100 mg by mouth two times a day (200 mg/day).
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Placebo
n=21 Participants
Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Placebo: Matching placebo capsules by mouth twice a day.
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Observational
n=35 Participants
No Intervention
|
|---|---|---|---|
|
Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms
|
51.5 Units on a scale *days
Standard Deviation 31.4
|
30.6 Units on a scale *days
Standard Deviation 19.9
|
36.2 Units on a scale *days
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: The blood sample collection was an optional procedure for the participants data were not collected.
Outcome measures
Outcome data not reported
Adverse Events
Minocycline
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Minocycline
n=23 participants at risk
Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Minocycline: 100 mg by mouth two times a day (200 mg/day).
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Placebo
n=21 participants at risk
Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Placebo: Matching placebo capsules by mouth twice a day.
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
|---|---|---|
|
Infections and infestations
Septic shock
|
8.7%
2/23 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
0.00%
0/21 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Cardiac disorders
Sudden cardiopulmonare
|
4.3%
1/23 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
0.00%
0/21 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
Other adverse events
| Measure |
Minocycline
n=23 participants at risk
Minocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Minocycline: 100 mg by mouth two times a day (200 mg/day).
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
Placebo
n=21 participants at risk
Matching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Placebo: Matching placebo capsules by mouth twice a day.
Questionnaires: Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.3%
1/23 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
0.00%
0/21 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Ear and labyrinth disorders
Vertigo
|
4.3%
1/23 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
0.00%
0/21 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
4.8%
1/21 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
2/23 • Number of events 2 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
0.00%
0/21 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/23 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
4.8%
1/21 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Gastrointestinal disorders
Weakness
|
0.00%
0/23 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
4.8%
1/21 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Gastrointestinal disorders
Splenic infiltarion
|
0.00%
0/23 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
4.8%
1/21 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/23 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
4.8%
1/21 • Number of events 1 • From start of study and the study completion, an average of 2 years,8 months
Adverse Events were not monitored/assessed for participants in the "Observational" Arm/Group.
|
Additional Information
Dr. David Fogelman/ Associate Professor, GI Medical Oncology
UT MD Anderson Cancer Center
Phone: 832-710-7754
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place