MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aspergillosis
Intervention: MK0991, caspofungin acetate (Drug); Comparator: amphotericin B (Drug); Comparator: lipid formulation of amphotericin B and/or azole (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
Invasive aspergillosis is a type of fungal infection typically identified in very sick
patients (for example, patients with cancer or who have had a bone marrow or organ
transplant). This study will seek to enroll patients (16 years of age or older) with
invasive aspergillosis infections (involving organs or deep tissues) who are failing or
could not tolerate standard antifungal therapy. Your doctor will make this determination
based upon specific study criteria. Patients that fulfill all study criteria will be
treated daily with both the investigational drug and another antifungal agent. The choice
of the other agent is up to your doctor. This investigational drug is approved for the
treatment of invasive aspergillosis by itself. The safety and efficacy of this
investigational drug, in combination with other agents is not known.
Clinical Details
Official title: A Multicenter, Open, Noncomparative Study to Estimate the Safety, Tolerability, and Efficacy of MK0991 in Combination With Amphotericin B, Lipid Formulations of Amphotericin B, or Azoles in the Treatment of Invasive Aspergillus Infection in Adults Who Are Refractory to or Intolerant of Standard Therapy
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Tolerability.
Secondary outcome: Clinical response
Detailed description:
The duration of treatment is 12 months.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
- Patients must meet a specific definition of probable or definite invasive
aspergillosis and be considered to have failed or be intolerant of standard
antifungal therapy.
- The patient must be at least 16 years old and if a woman of childbearing potential,
must have a negative serum or urine pregnancy test sensitive to 25 IU hCG prior to
enrollment.
Locations and Contacts
Additional Information
Related publications: Maertens J, Glasmacher A, Herbrecht R, Thiebaut A, Cordonnier C, Segal BH, Killar J, Taylor A, Kartsonis N, Patterson TF, Aoun M, Caillot D, Sable C; Caspofungin Combination Therapy Study Group. Multicenter, noncomparative study of caspofungin in combination with other antifungals as salvage therapy in adults with invasive aspergillosis. Cancer. 2006 Dec 15;107(12):2888-97.
Starting date: January 2003
Last updated: January 12, 2015
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