Trial Outcomes & Findings for Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC) (NCT NCT00750737)

NCT ID: NCT00750737

Last Updated: 2016-09-29

Results Overview

Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 46 participants
• Primary outcome timeframe: Within 7 days of antifungal prophylaxis therapy
• Results posted on: 2016-09-29

Participant Flow

Recruitment Period: July 2008 to May 2009. All recruitment done at UT MD Anderson Cancer Center.

A total of 46 participants were randomized, out of which 40 participants were included in the analysis and 6 participants withdrew consent.

Participant milestones

Measure	Posaconazole 200 mg Oral Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)	Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV 7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
Overall Study STARTED	24	22
Overall Study COMPLETED	21	19
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Posaconazole 200 mg Oral Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)	Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV 7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
Overall Study Withdrawal by Subject	3	3

Baseline Characteristics

Oral Posaconazole Three Times Per Day vs Weekly High Dose Amphotericin B Lipid Complex (ABLC)

Baseline characteristics by cohort

Measure	Posaconazole 200 mg Oral n=24 Participants Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)	Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV n=22 Participants 7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)	Total n=46 Participants Total of all reporting groups
Age, Continuous	55.5 years n=93 Participants	56 years n=4 Participants	55.5 years n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants	20 Participants n=4 Participants	43 Participants n=27 Participants
Age, Categorical >=65 years	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	13 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	19 Participants n=93 Participants	9 Participants n=4 Participants	28 Participants n=27 Participants
Region of Enrollment United States	24 participants n=93 Participants	22 participants n=4 Participants	46 participants n=27 Participants

PRIMARY outcome

Timeframe: Within 7 days of antifungal prophylaxis therapy

Population: Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.

Percentage of participants that developed IFI within 7 days of antifungal prophylaxis therapy (Posaconazole or ABLC).

Outcome measures

Measure	Posaconazole 200 mg Oral n=21 Participants Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)	Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV n=19 Participants 7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
Incidence of Invasive Fungal Infection (IFI)	0 percentage of participants	5 percentage of participants

SECONDARY outcome

Timeframe: Day 1 through Day 42

Population: Out of 46 participants, 40 were included in the analysis and 6 withdrew consent.

Success: Defined as the absence of proven or probable invasive fungal infection through the end of prophylaxis and absence of Grade 1-4 toxicity related to prophylaxis requiring the discontinuation of the drug. Failure: Presence of proven or probable fungal infection or development of Grade 1-4 toxicity related to prophylaxis while on study drug and requiring discontinuation of study drug or inability to tolerate intravenous ABLC (due to infusion related toxicities) or oral Posaconazole (due to mucositis or vomiting).

Outcome measures

Measure	Posaconazole 200 mg Oral n=21 Participants Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)	Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV n=19 Participants 7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
Efficacy Outcome Measured as Success or Failure Success	62 percentage of participants	21 percentage of participants
Efficacy Outcome Measured as Success or Failure Failure	38 percentage of participants	79 percentage of participants

Adverse Events

Posaconazole 200 mg Oral

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Posaconazole 200 mg Oral n=21 participants at risk Posaconazole 200 mg three times daily by mouth up to 6 weeks (Days 1-42)	Amphotericin B Lipid Complex (ABLC) 7.5 mg/kg IV n=19 participants at risk 7.5 mg/kg of ABLC intravenously infused over 4-6 hours once per week, for up to 6 weeks (from Day 1 through Day 42)
Metabolism and nutrition disorders Hypomagnesemia	28.6% 6/21 • Number of events 6 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	42.1% 8/19 • Number of events 8 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
General disorders Chills	4.8% 1/21 • Number of events 1 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	31.6% 6/19 • Number of events 6 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
Metabolism and nutrition disorders Increase in ALT	47.6% 10/21 • Number of events 10 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	26.3% 5/19 • Number of events 5 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
Metabolism and nutrition disorders Increase in Bilirubin	33.3% 7/21 • Number of events 7 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	21.1% 4/19 • Number of events 4 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
Gastrointestinal disorders Nausea	66.7% 14/21 • Number of events 14 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	52.6% 10/19 • Number of events 10 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
Gastrointestinal disorders Vomiting	28.6% 6/21 • Number of events 6 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	26.3% 5/19 • Number of events 5 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
Gastrointestinal disorders Diarrhea	66.7% 14/21 • Number of events 14 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	42.1% 8/19 • Number of events 8 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
Infections and infestations Invasive Fungal Infection	0.00% 0/21 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	5.3% 1/19 • Number of events 1 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.
Metabolism and nutrition disorders Increase in Creatinine	23.8% 5/21 • Number of events 5 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.	84.2% 16/19 • Number of events 16 • Adverse Events (AEs) were evaluated from the time of the first infusion of study drug through the end of the post-treatment visit. Collection period: July 10, 2008 to July 31, 2009.

Additional Information

Issam Raad, MD / Chair, Infectious Diseases

University of Texas (UT) MD Anderson Cancer Center

Phone: 713-792-7943

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place