Trials / Terminated
TerminatedNCT01066468
Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders.
A Non-randomized, Open-label Study to Characterize the Pharmacokinetics (PK) of Glivec/Gleevec® (Imatinib Mesylate) in Pediatric (Age Range 1 to Less Than 4 Years) Patients With Chronic Myeloid Leukemia (CML) or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) or Other Glivec/ Gleevec® Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 1 Year – 3 Years
- Healthy volunteers
- Not accepted
Summary
This study will assess the pharmacokinetics of imatinib in pediatric patients ages 1 to \<4 years of age to help develop dosing regimens
Conditions
- Chronic Myeloid Leukemia (CML)
- Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
- Other Glivec/Gleevec Indicated Hematological Disorders (HES, CEL, MDS/ MPN)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gleevec/Glivec |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2011-05-01
- First posted
- 2010-02-10
- Last updated
- 2012-03-13
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT01066468. Inclusion in this directory is not an endorsement.