A Phase 4 Study of the Pharmacokinetics of Oral Posaconazole Among Patients with Compromised Gastrointestinal Function and at High Risk for Invasive Fungal Infection. - N/A

• Conditions: Acute Myeloid Leukemia, Neutropenia, Antifungal Prophylaxis, Gastrointestinal Disorders; MedDRA version: 9.1Level: LLTClassification code 10000880Term: Acute myeloid leukaemia; MedDRA version: 9.1Level: LLTClassification code 10029354Term: Neutropenia; MedDRA version: 9.1Level: LLTClassification code 10049085Term: Antifungal prophylaxis; MedDRA version: 9.1Level: HLTClassification code 10017948Term: Gastrointestinal disorders NEC

• Registration Number: EUCTR2007-003148-31-DE
• Lead Sponsor: Schering-Plough Research Institute, A Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-28
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. Basic demographics: Adult subjects (greater than or equal to 18 years, or minimal age that defines an adult according to local regulations, to less than or equal to 75 years) of either sex or any race.

2. High risk of poor enteral medication absorption, based on the effects of cytotoxic chemotherapy, as evidenced by, but not limited to, mucositis, nausea, vomiting, and diarrhea, at baseline.

3. Subjects who are at high risk for IFI based on anticipated or documented prolonged neutropenia (ANC <500/mm3 [0.5 x 109/L]) due to any ONE of the following conditions:

a. Standard intensive induction or consolidation chemotherapy, anthracycline-based or other accepted regimen (excluding any Phase 1 or Phase 2 investigational agent), for a new diagnosis of AML, OR

b. Reinduction or consolidation chemotherapy for AML in first relapse or dose intensification for salvage of refractory AML (excluding any Phase 1 or Phase 2 investigational agent), OR

c. Myelosuppressive induction or consolidation therapy for myelodysplastic syndromes in transformation to AML or other diagnoses of secondary AML (therapy related, antecedent hematological disorders) or chronic myelogenous leukemia in blast crisis (excluding any Phase 1 or Phase 2 investigational agent).

4. Subjects' clinical laboratory safety tests (blood chemistries) must be within normal limits or clinically acceptable to the investigator or sponsor (ie, show no Grade 3 or 4 renal or hepatic abnormalities or other abnormalities that are Grade 4 [life-threatening] and which are expected to remain unstable and could interfere with study assessments).

5. Subjects must be free of any clinically significant disease (other than the primary hematologic disease) that would interfere with the study evaluations.

6. Subjects (and/or parent/guardian for subjects under 18 years of age) must be willing to give written informed consent and able to adhere to dosing, study visit schedule, and mandatory procedures (as long as local regulations are met).

7. Female subjects of childbearing age must be using a medically accepted method of birth control before beginning study-drug treatment and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy or tubal ligation). Female subjects of childbearing potential should be counseled in the appropriate use of birth control while in this study. Female subjects who are not currently sexually active must agree and consent to use one of the above-mentioned methods should they become sexually active while participating in the study.

8. Female subjects of childbearing potential must have a negative serum pregnancy test at Baseline or within 72 hours before the start of study drug.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Female subjects who are pregnant, intend to become pregnant, or are nursing.

2. Excluded prior treatments. Subjects receiving systemic antifungal therapy (oral, intravenous, or inhaled) for the treatment of proven or probable IFI within 30 days prior to enrollment.

3. Subjects receiving posaconazole for prophylaxis against IFI within 10 days prior to enrollment. (Subjects who are receiving other systemic (oral, intravenous or inhaled) antifungal prophylaxis against IFI should discontinue those therapies upon enrollment.)

4. Subjects with moderate or severe liver dysfunction at Baseline, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than two times the upper limit of normal (ULN), or a total bilirubin level greater than two times the ULN.

5. Excluded treatments prior to enrollment. Subjects who have taken prohibited medications more recently than the indicated washout period prior to Enrollment.

6. Excluded treatments during the study. Subjects who must take prohibited medications during the study.

7. Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study , ie, any condition requiring the use of prohibited drugs or unstable medical conditions other than the hematological disorder such as cardiac or neurologic disorder or impairment expected to be unstable or progressive during the course of this study (eg, seizures or demyelinating syndromes, acute myocardial infarction within 3 months of study entry, myocardial ischemia, or unstable congestive heart failure, unstable arrhythmias, atrial fibrillation with ventricular rate <60/min, or history of torsades de pointes, symptomatic ventricular or sustained arrhythmias, unstable electrolyte abnormalities (eg, =Grade 2 hypokalemia or hypomagnesemia).

8. Subjects who have used any investigational drugs or biologic agents other than their chemotherapy regimens within 30 days of study entry.

9. Subjects who are part of the staff personnel directly involved with this study.

10. Subjects who are a family member of the investigational study staff.

11. Prior enrollment in this study.

12. Subjects with a history of hypersensitivity or idiosyncratic reactions to azole agents.

13. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status >2 prior to induction chemotherapy for their underlying disease.

14. Subjects with proven or probable invasive fungal infection, according to EORTC-MSG criteria (Appendix 3), at Baseline.

15. Subjects with a history of acute lymphoblastic leukemia or chronic myelogenous leukemia without blast crisis.

16. Subjects with an ECG with QTc interval greater than 450 msec for men and greater than 470 msec for women at baseline.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified