Pharmacokinetics of Posaconazole Prophylaxis in Acute Leukemia

NCT00936117 | Completed Phase 2 Results

• 1 other identifier: 2008-0793
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn the amount of posaconazole that is in the body at different time points when given to patients with leukemia. The safety of this drug will also be studied. Objectives: Primary: To study the plasma pharmacokinetics of posaconazole in patients with newly diagnosed acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS) undergoing induction chemotherapy or relapsed or refractory patients who will receive salvage chemotherapy. Secondary: To evaluate the safety of posaconazole given as prophylaxis.

Conditions

Leukemia; Fungal Infection

Keywords

Cancer of the Blood; Cancer of Bone Marrow; Acute Leukemia; AML; Fungal infection; Prophylaxis; Posaconazole; SCH 56592; Noxafil; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Maximum Observed Concentration in Plasma (Cmax)

  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.

  Pharmacokinetics: Day 1, Day 3 and Day 10 of prophylaxis.

Study Arms (1)

Posaconazole

EXPERIMENTAL

Posaconazole 200 mg (liquid) by mouth 3 times per day.

Drug: Posaconazole

Interventions

Posaconazole DRUG

200 mg (liquid) by mouth 3 times per day.

Also known as: SCH 56592, Noxafil

Posaconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients newly diagnosed with AML or high-risk MDS undergoing induction chemotherapy or refractory or relapsed patients with AML or high-risk MDS who will receive first or second salvage chemotherapy. (Salvage patients are defined as patients that achieved remission and relapsed or patients who were refractory to initial frontline chemotherapy)
• Age \> 18 years and able to take oral intake.
• Patients must sign an informed consent.
• Patients agree to medically approved forms of contraception
• Patients on prior antifungal prophylaxis with voriconazole, itraconazole or fluconazole are eligible if they completed 3 days wash-out period if on voriconazole, or 14 days wash-out period if on itraconazole or 7 days wash-out period if on fluconazole

You may not qualify if:

• Patients with history of anaphylaxis attributed to azole compounds
• Patients with clinical or other evidence that indicates that they have proven or probable invasive fungal infection prior to enrollment (EORTC criteria)
• Patients with baseline total bilirubin levels \> 3 times the upper normal limits (i.e. \> 3.0 mg/dl); or baseline SGPT \> 5 times upper limit normal.
• Patients receiving any medication that is contraindicated with the use of posaconazole
• Patients with baseline creatinine levels NCI grade 3 or above (\> 3.0 - 6.0 X ULN)
• Patients with baseline QTc prolongation NCI grade 1 or above (QTc \> 0.45 - 0.47 seconds).

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Schering-Plough: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Leukemia; Mycoses; Bone Marrow Neoplasms

Interventions

posaconazole

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bacterial Infections and Mycoses; Infections; Hematologic Neoplasms; Neoplasms by Site; Bone Marrow Diseases

Results Point of Contact

• Title: Jorge Cortes, MD/Professor, Leukemia Department
• Organization: University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-745-2723

Study Officials

• Jorge Cortes, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 27, 2019
• Results First Posted: September 24, 2015

Record last verified: 2019-02

Locations

US (1)