A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Information source: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Solid Tumors; Relapsed/Refractory Lymphoma
Intervention: Alisertib (Drug); Itraconazole (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Millennium Pharmaceuticals, Inc. Overall contact: Takeda Study Registration Call Center, Phone: +1-877-825-3327, Email: medicalinformation@tpna.com
Summary
This study will assess the effect of multi-dose administration of itraconazole on the
single-dose pharmacokinetics (PK) of alisertib.
Clinical Details
Official title: A Phase 1 Study to Evaluate the Effect of Itraconazole, a Strong CYP3A Inhibitor, on the Pharmacokinetics of Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: Cmax: Maximum Observed Concentration of Alisertib in Presence and Absence of Itraconazole in Part AAUC(0-last): Area Under the Plasma Concentration Curve from Time Zero to the Time of the Last Quantifiable Concentration of Alisertib in Presence and Absence of Itraconazole in Part A AUC(0-inf): Area under the Plasma Concentration Curve from Time Zero to Infinity of Alisertib in Presence and Absence of Itraconazole in Part A
Secondary outcome: CL/F: Oral Clearance of Alisertib in Presence and Absence of Itraconazole in Part ATmax:Time to Achieve Maximum Plasma Concentration of Alisertib in Presence and Absence of Itraconazole in Part A T½: Terminal Phase Elimination Half-Life of Alisertib in Presence and Absence of Itraconazole in Part A Cmax of Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A Tmax of Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A AUC(0-last) of Alisertib metabolites M1 and M2 of Alisertib in Presence and Absence of Itraconazole in Part A Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of Participants with Markedly Abnormal Laboratory Values Change from Baseline in Weight Change from Baseline in Vital Sign Measurements
Detailed description:
The drug being tested in this study is called alisertib. Alisertib is being tested in adult
patients with advanced solid tumors or relapsed refactory lymphoma. The study will look at
the effect of the pharmacokinetics (how the drug moves through the body) of alisertib in the
presence and absence of itraconazole.
This is an open label study. Participants will receive:
- Alisertib tablets 30 mg in Part A and 50 mg in Part B
- Itraconazole oral solution 200 mg in Part A
Participation in Part A is 14 days. The maximum duration of treatment with alisertib will be
12 months (approximately 16 cycles) unless it is determined by the investigator, with
agreement by the sponsor, that a patient would derive clinical benefit from continued
treatment beyond 12 months.
This multi-centre study will take place in the United States.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
1. Male and female patients 18 years of age or older.
2. Patients with histologic or cytologic diagnosis of advanced or metastatic solid
tumors or lymphomas for which no curative or life-prolonging therapies exist.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria
1. Systemic treatment with moderate or strong CYP3A inhibitors or inducers must be
discontinued at least 14 days before the first dose of alisertib, and the use of
these agents is not permitted during the study (except for the protocol-specified
administration of itraconazole).
2. Known gastrointestinal (GI) abnormality (including recurrent nausea or vomiting) or
GI procedure that could interfere with or modify the oral absorption or tolerance of
alisertib.
3. Known hypersensitivity or intolerance to itraconazole or similar class agents.
Locations and Contacts
Takeda Study Registration Call Center, Phone: +1-877-825-3327, Email: medicalinformation@tpna.com
St. Louis, Missouri, United States; Recruiting
Oklahoma City, Oklahoma, United States; Recruiting
Germantown, Tennessee, United States; Recruiting
Dallas, Texas, United States; Recruiting
Additional Information
Starting date: October 2014
Last updated: March 31, 2015
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