Trial Outcomes & Findings for Voraxaze for Delayed Methotrexate Clearance (NCT NCT00424645)

Results Overview

Response rate defined as proportion of patients that clear methotrexate (MTX) at 15 min and 24-hour post infusion of study drug, Glucarpidase (Voraxaze) to total patient number. Serum MTX levels (standard methods and mass spectrometry) at 15 minutes, 24 hours, or daily until MTX clearance defined as serum MTX level \<0.1 µmol/L.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Study period 2 years

Results posted on

2012-12-06

Participant Flow

Recruitment Period: 01/09/07 through 01/31/08. All participants recruited at UT MD Anderson Cancer Center.

Study closed early by sponsor due to low accrual. Of three patients enrolled, only two patients received blinded study drug. Study terminated prior to other randomization.

Participant milestones

Participant milestones
Measure	Voraxaze Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.	Placebo Placebo administered IV following Voraxaze arm.
Overall Study STARTED	3	0
Overall Study COMPLETED	2	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Voraxaze Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.	Placebo Placebo administered IV following Voraxaze arm.
Overall Study Death	1	0

Baseline Characteristics

Voraxaze for Delayed Methotrexate Clearance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Voraxaze n=3 Participants Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.	Placebo Placebo administered IV following Voraxaze arm.	Total n=3 Participants Total of all reporting groups
Age Continuous	64 years n=5 Participants	—	64 years n=5 Participants
Gender Female	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Male	3 participants n=5 Participants	—	3 participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Study period 2 years

Population: Analysis was to be per protocol, low accrual and early termination led too few responses for evaluation.

Response rate defined as proportion of patients that clear methotrexate (MTX) at 15 min and 24-hour post infusion of study drug, Glucarpidase (Voraxaze) to total patient number. Serum MTX levels (standard methods and mass spectrometry) at 15 minutes, 24 hours, or daily until MTX clearance defined as serum MTX level \<0.1 µmol/L.

Outcome measures

Outcome data not reported

Adverse Events

Voraxaze

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Voraxaze n=3 participants at risk Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.	Placebo Placebo administered IV following Voraxaze arm.
Blood and lymphatic system disorders Fever with Hypotension	33.3% 1/3 • Number of events 1 • 11 months	— 0/0 • 11 months
Renal and urinary disorders Myelosuppression	33.3% 1/3 • Number of events 1 • 11 months	— 0/0 • 11 months

Additional Information

Saroj Vadhan, MD

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place