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Cancidas

Clinical Pharmacology
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Clinical Pharmacology

*Patients received CANCIDAS 70 mg on Day 1, then 50 mg daily for the remainder of their treatment.

**Study defined as study treatment period and 6-8 week follow-up period.

***Determined by the investigator to be possibly, probably, or definitely drug-related.

Of the 239 patients enrolled, 224 met the criteria for inclusion in the MITT population (109 treated with CANCIDAS and 115 treated with amphotericin B). Of these 224 patients, 186 patients had candidemia (92 treated with CANCIDAS and 94 treated with amphotericin B). The majority of the patients with candidemia were non-neutropenic (87%) and had an APACHE II score less than or equal to 20 (77%) in both arms. Most candidemia infections were caused by C. albicans (39%), followed by C. parapsilosis (20%), C. tropicalis (17%), C. glabrata (8%), and C. krusei (3%).

At the end of IV study therapy, CANCIDAS was comparable to amphotericin B in the treatment of candidemia in the MITT population. For the other efficacy time points (Day 10 of IV study therapy, end of all antifungal therapy, 2-week post-therapy follow-up, and 6- to 8-week post-therapy follow-up), CANCIDAS was as effective as amphotericin B.

Outcome, relapse and mortality data are shown in Table 3.

TABLE 3

Outcomes, Relapse, & Mortality in Candidemia and Other Candida Infections (Intra-abdominal abscesses, peritonitis, and pleural space infections)

 
CANCIDAS*
Amphotericin B
% Difference** after
adjusting for strata
(Confidence Interval)***
Number of MITT† patients
109
115
 
FAVORABLE OUTCOMES (MITT) AT THE END OF IV STUDY THERAPY
All MITT patients
81/109 (74.3%)
78/115 (67.8%)
7.5 (-5.4, 20.3)
Candidemia
Neutropenic
Non-neutropenic
67/92 (72.8%)
6/14 (43%)
61/78 (78%)
63/94 (67.0%)
5/10 (50%)
58/84 (69%)
7.0 (-7.0, 21.1)
Endophthalmitis
0/1
2/3
 
Multiple Sites
Blood / Pleural
Blood / Peritoneal
Blood / Urine
Peritoneal / Pleural
Abdominal / Peritoneal
Subphrenic / Peritoneal
4/5
1/1
1/1
-
1/2
-
1/1
4/4
1/1
1/1
1/1
-
1/1
-
 
DISSEMINATED INFECTIONS, RELAPSES AND MORTALITY
Disseminated Infections in neutropenic patients
4/14 (28.6%)
3/10 (30.0%)
 
All relapses††
Culture-confirmed relapse
7/81 (8.6%)
5/81 (6%)
8/78 (10.3%)
2/78 (3%)
 
Overall study††† mortality in MITT
Mortality during study therapy
Mortality attributed to Candida
36/109 (33.0%)
18/109 (17%)
4/109 (4%)
35/115 (30.4%)
13/115 (11%)
7/115 (6%)
 
Brand Name: Cancidas
Generic Name: Caspofungin Acetate
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