MK0991 in Combination With Standard Antifungal Agent(s) for the Treatment of Salvage Invasive Aspergillosis (0991-037)

Aspergillosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076869
• Other study ID #: 0991-037
• Secondary ID: Formally-0121FI2
• Status: Completed
• Phase: Phase 2
• First received: February 5, 2004
• Last updated: January 12, 2015
• Start date: January 2003
• Est. completion date: August 2005

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

The duration of treatment is 12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: August 2005
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis

Intervention

Drug:
• MK0991, caspofungin acetate

• Comparator: amphotericin B

• Comparator: lipid formulation of amphotericin B and/or azole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability.
Secondary	Clinical response