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NCT01324336 Clinical Trial

Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01324336
Other study ID # 6-MP pharmacokinetic 1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2011
Est. completion date December 2013

Study information
Verified date December 2020
Source Children's Mercy Hospital Kansas City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL).

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender All
Age group 4 Years to 17 Years
Eligibility Inclusion Criteria: - Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for ALL with 6-MP will be included. Exclusion Criteria: - Inability to have blood drawn for the screening lab tests - Received methotrexate or folate supplement within the last 24 hours - Pregnant or lactating females - Inability to swallow a pill - Hemoglobin less or equal to 8 gm/dl - Presence of significant co-morbid illness that makes child ineligible as deemed by the investigator - Weight < or = 16 kg

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 6-Mercaptopurine
75 mg/m2/dose/day

Locations
Country Name City State
United States The Children's Mercy Hospital Kansas City Missouri

Sponsors (2)
Lead Sponsor Collaborator
Children's Mercy Hospital Kansas City Midwest Cancer Alliance

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of 6-MP To compare the pharmacokinetics of a routinely used compounded liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients who are receiving treatment with 6-MP as part of their clinical treatment for acute lymphoblastic leukemia (ALL). 8 hours post administration
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