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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 A

AUC(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 A

Tmax: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

Page last updated: August 23, 2015

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