Trial Outcomes & Findings for Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia (NCT NCT00936117)
NCT ID: NCT00936117
Last Updated: 2019-02-27
Results Overview
Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day. Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 - 5000 ng/ml. There are no established therapeutic ranges for posaconazole.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.
Results posted on
2019-02-27
Participant Flow
Recruitment Period: September 30, 2009 to January 3, 2011. From January 2010 through August 2010, adult with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing induction chemotherapy or first salvage therapy were recruited at The University of Texas (UT) MD Anderson Cancer Center.
Of the 25 participants enrolled, five participants were excluded from the trial -- two were ineligible, one withdrew consent before start of treatment, another two were excluded from the study for other reasons.
Participant milestones
| Measure |
Posaconazole
Posaconazole 200 mg (liquid) by mouth 3 times per day.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Posaconazole
Posaconazole 200 mg (liquid) by mouth 3 times per day.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Unable to continue oral medication
|
3
|
Baseline Characteristics
Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia
Baseline characteristics by cohort
| Measure |
Posaconazole
n=20 Participants
Posaconazole 200 mg (liquid) by mouth 3 times per day.
|
|---|---|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
|
Participant Diagnosis
AML, Induction
|
19 participants
n=5 Participants
|
|
Participant Diagnosis
AML, Relapse
|
1 participants
n=5 Participants
|
|
Chemotherapy Received
Cytarabine-containing regimen
|
9 participants
n=5 Participants
|
|
Chemotherapy Received
Clofarabine-containing regimen
|
8 participants
n=5 Participants
|
|
Chemotherapy Received
Miscellaneous*
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.Population: Of the 11 females enrolled, one was not evaluable for the outcome thus excluded from analysis.
Pharmacokinetic samples were obtained on day 1, day 3 and day 10 of prophylaxis. A total of 15 samples (3 ml each sample) per participant were obtained, with thrice daily dosing planned around standard meal times. On day 1 and day 3 of prophylaxis sampling was done pre dose (0), and at 3, 5, 10 and 24 hours (±10 minutes) post dose from the time of the first dose of the day. On day 10 of prophylaxis sampling was done pre dose (0), and at 3, 5, and 10 hours (±10 minutes) post dose from the time of the first dose of the day. Posaconazole levels were assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 125 - 5000 ng/ml. There are no established therapeutic ranges for posaconazole.
Outcome measures
| Measure |
Posaconazole (Females)
n=10 Participants
Posaconazole 200 mg (liquid) by mouth 3 times per day.
|
Posaconazole (Males)
n=9 Participants
Posaconazole 200 mg (liquid) by mouth 3 times per day.
|
|---|---|---|
|
Maximum Observed Concentration in Plasma (Cmax)
Day 2, Hour 24
|
200 ng/ml
Interval 140.0 to 660.0
|
290 ng/ml
Interval 120.0 to 770.0
|
|
Maximum Observed Concentration in Plasma (Cmax)
Day 4, Hour 24
|
300 ng/ml
Interval 140.0 to 1820.0
|
580 ng/ml
Interval 260.0 to 1090.0
|
|
Maximum Observed Concentration in Plasma (Cmax)
Day 9, Hour 24
|
770 ng/ml
Interval 140.0 to 2450.0
|
800 ng/ml
Interval 370.0 to 1690.0
|
Adverse Events
Posaconazole
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Posaconazole
n=20 participants at risk
Posaconazole 200 mg (liquid) by mouth 3 times per day.
|
|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
10.0%
2/20 • Number of events 2 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Acid Reflux
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Psychiatric disorders
Altered Mental Status
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Eye disorders
Blurry Vision
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
General disorders
Body Aches
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Cardiac disorders
Cardiac Arrest
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
5/20 • Number of events 5 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Diarrhea
|
65.0%
13/20 • Number of events 13 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
General disorders
Edema
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Metabolism and nutrition disorders
Elevated Alanine Aminotransferase (ALT)
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Metabolism and nutrition disorders
Elevated Bilirubin
|
15.0%
3/20 • Number of events 3 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Esophagitis
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Respiratory, thoracic and mediastinal disorders
Fungal Pneumonia
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Nervous system disorders
Headache
|
10.0%
2/20 • Number of events 2 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Cardiac disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Nervous system disorders
Intracranial Hemmorrhage
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Mouth Sores
|
10.0%
2/20 • Number of events 2 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • Number of events 5 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
40.0%
8/20 • Number of events 9 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Gastrointestinal disorders
Odynophagia
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.0%
6/20 • Number of events 6 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Reproductive system and breast disorders
Testicular Cyst
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
|
Metabolism and nutrition disorders
Transaminitis
|
5.0%
1/20 • Number of events 1 • Adverse event data collected to 42 days following start of treatment, overall study period January 19, 2010 to February 11, 2011.
The adverse events presented below reflect all SAEs and AEs reported by participants, regardless of whether events were treatment-related or non-treatment-related.
|
Additional Information
Jorge Cortes, MD/Professor, Leukemia Department
University of Texas (UT) MD Anderson Cancer Center
Phone: 713-745-2723
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place