Phase 1 N=15 Treatment

A Pharmacokinetic (PK) Study of Nilotinib in Pediatric Patients With Philadelphia Chromosome-positive (Ph+) Chronic Myelogenous Leukemia (CML) or Acute Lymphoblastic Leukemia (ALL)

Chronic Myeloid Leukemia · Acute Lymphoblastic Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT01077544 ↗

Enrolled (actual)

Serious AEs

33.3%

Results posted

Jan 2016

Primary outcome: Primary: Summary of Nilotinib Non-compartmental PK Parameters: Cmax — 405.111; 402.715 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Nilotinib (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jul 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Summary of Nilotinib Non-compartmental PK Parameters: Cmax	405.111; 402.715	—
PRIMARY Summary of Nilotinib Non-compartmental PK Parameters: Tmax	2.000; 3.000	—
PRIMARY Summary of Nilotinib Non-compartmental PK Parameters: AUClast (Last = 24h)	4160.969; 5707.368	—
PRIMARY Summary of Nilotinib Non-compartmental PK Parameters: AUC0-12h	2795.782; 3393.296	—
PRIMARY Summary of Nilotinib Steady-state PK Parameters: AUCss	15129.182; 14383.076	—
PRIMARY Summary of Nilotinib Steady-state PK Parameters: CLF (Body Surface Area (BSA) Adjusted)	15.356; 15.922	—
PRIMARY Summary of Nilotinib Steady-state PK Parameters: Cmin	804.791; 1072.850	—
SECONDARY Number of Ph+ CML Participants With Confirmed Complete Hematologic Response (CHR)	5; 5; 0; 1	—
SECONDARY Number of Ph+ CML Participants With Cytogenic Response	2; 2; 0; 1; 0; 1	—
SECONDARY Number of Ph+ CML Participants With Major Molecular Response (MMR)	1; 2; 4; 4	—
SECONDARY Efficacy Endpoints for Ph+ ALL Patients	2; 1; 0; 0; 0; 0	—

Summary

This study will assess the pharmacokinetics of nilotinib in Ph+ CML pediatric patients that are newly diagnosed or resistant or intolerant to imatinib or dasatinib or refractory or relapsed Ph+ ALL compared to the adult populations. It will also evaluate safety and activity of nilotinib as secondary objectives.

Eligibility Criteria

Inclusion Criteria

Must have one of the following: newly diagnosed CP Ph+CML, CP or AP resistant/ intolerant to imatinib and/or dasatinib, or Ph+ ALL either relapsed after or refractory to standard therapy
adequate renal, hepatic and pancreatic function

Exclusion Criteria

patients receiving therapy with strong CYP3A4 inhibitors and/or inducers and treatments cannot be stopped or changed to a different medication at least 14 days prior to starting study drug
patients receiving therapy with any medications with a known risk or possible risk to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
gastrointestinal impairment or disease that may interfere with drug absorption
liver, pancreatic or severe renal disease unrelated to disease under study
impaired cardiac function
patients who received dasatinib within 3 days of starting study drug
patients who received imatinib within 5 days of starting study drug
patients receiving hydroxyurea or corticosteroids that has not been discontinued at least 1 week after initiation of nilotinib
patients who received hematopoietic growth factors within 7 days of starting study drug or Pegfilgrastim (Neulasta®) within 14 days of starting study drug
patients with Stem Cell Transplant (SCT) or Rescue without TBI: Evidence of active graft vs. host disease and < 3 months since SCT

Other protocol-defined inclusion/exclusion criteria may apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01077544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.