Single Patient Treatment of Posaconazole in Invasive Fungal Infections (Study P05113)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686621
First received: May 27, 2008
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to provide posaconazole compassionate treatment to patients with invasive fungal infections: 1) which are resistant to standard antifungal therapies; 2) for which there are no effective therapies; 3) with a prior history of serious, severe, or life-threatening toxicities while receiving standard antifungal therapies, or 4) with pre-existing organ dysfunction which precludes the use of standard antifungal therapies.


Condition Intervention Phase
Mycoses
Drug: Posaconazole
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Patient Emergency Treatment Use of Posaconazole in Invasive Fungal Infections

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Clinical efficacy and safety of use [ Time Frame: Clinical outcome and adverse events measured every 3 months until the drug is marketed in the country. ] [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: January 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single arm Drug: Posaconazole
Posaconazole oral suspension 400 mg twice daily with meal or nutritional supplement. Alternatively, if meal or nutritional supplement is not tolerated, posaconazole should be administered at a dose of 200 mg four times a day.
Other Name: SCH 056592

Detailed Description:

NCT00686621 was voluntarily registered even though it is a single patient use study, also known as compassionate exemption study; therefore results will not be disclosed for this study.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

General Inclusion Criteria:

  • Adults (age >=18 years) of either gender and of any race.
  • Children (age >= 2 to 17 years) of either gender and of any race, who are not eligible for enrollment under any current clinical trial. Compassionate use will be permitted only under the direct supervision of qualified experts in pediatric infectious diseases with the written approval of the Schering Plough medical director (local country operations or headquarters project director).
  • Subject or his/her legally authorized representative has given signed, written informed consent,
  • Ability to take study medication orally by swallowing or via an enteral feeding tube.
  • Subject is not considered eligible for any other clinical research program with posaconazole.

Safety Related Inclusion Criteria

  • Male or a female patient who meets any one of the following criteria:

    • postmenopausal, surgically sterilized, or documented to have primary ovarian failure due to prior cytotoxic chemotherapy or radiation therapy; abstinent from sexual intercourse or practicing effective birth control. Effective birth control methods must continue for at least 30 days after discontinuation of treatment with posaconazole.
  • Known to be non pregnant by history or (preferably) by negative serum or urine pregnancy test prior to the first dose of posaconazole for all females of childbearing potential.
  • Not breast feeding or if lactating, willing to discontinue breast feeding during treatment.

Invasive Fungal Infection Inclusion Criteria

  • Each patient must have:

    • A documented invasive fungal infection who have failed a reasonable trial of other licensed antifungal agents, either due to progression or lack of improvement of the infection, or
    • Serious, severe or life-threatening toxicities related to current or prior antifungal therapy, or
    • An invasive fungal infection for which there are currently no effective therapies.
  • Patients with debilitating but not immediately life threatening fungal diseases, where significant morbidity may result in disability and where prior antifungal therapy has been unsuccessful (eg, chronic mucocutaneous candidiasis, recurrent oropharyngeal or esophageal candidiasis with dehydration and malnutrition, or cutaneous phaeohyphomycosis and mycetoma).

Exclusion Criteria:

  • Women who are pregnant or who will continue to breast-feed infants.
  • History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.
  • Patients who require ongoing treatment with any prohibited medication (see Core Clinical Data Sheet and list of Prohibited Medications) and for whom an appropriate washout period has not elapsed.
  • Patients who are in a situation or have any condition requiring the use of prohibited drugs or unstable medical conditions where the risk of therapy would exceed any potential benefit i.e., hematological disorder such as unstable cardiac disorder (including acute myocardial infarction or unstable myocardial ischemia/angina within 30 days, ventricular arrhythmia within 30 days, uncontrolled atrial fibrillation, or atrial fibrillation/flutter with symptomatic bradycardia [sick sinus syndrome], or unstable congestive heart failure) or impairment expected to be unstable or progressive during the course of this study (e.g., recurrent or uncontrolled seizure disorders, demyelinating syndromes, or progressive peripheral neuropathy).
  • Patients receiving vinca alkaloids or anthracyclines within 24 hours of study enrollment or requiring therapy with vinca alkaloids or anthracyclines within the next 30 days for treatment of uncontrolled (pre-existing) malignancy or requiring ongoing therapy with vinca alkaloids or anthracyclines, where the risk of toxicity from these medicinal products is considered to be significant.
  • Any condition requiring the use of prohibited drugs (please consult current product labeling).
  • Hepatic function tests: alanine amino transferase (ALT) or aspartate aminotransferase (AST) >10 times upper limit of normal, or evidence of severe hepatic dysfunction based on other clinical assessment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686621     History of Changes
Other Study ID Numbers: P05113
Study First Received: May 27, 2008
Last Updated: October 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014