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Trial record 87 of 205 for:    SPORANOX I.V. OR ITRACONAZOLE OR ONMEL OR SPORANOX-PULSE OR Sporanos OR R 51,211 OR SPORANOX

A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

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ClinicalTrials.gov Identifier: NCT02259010
Recruitment Status : Unknown
Verified January 2016 by Millennium Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Brief Summary:
This study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (PK) of alisertib.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Relapsed/Refractory Lymphoma Drug: Alisertib Drug: Itraconazole Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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 Start Date : October 2014
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Part A: Alisertib 30 mg + Itraconazole
Alisertib 30 mg, tablets, orally, on Day 1 and Day 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13.
Drug: Alisertib
Alisertib tablets

Drug: Itraconazole
Itraconazole oral solution
Other Name: SPORANOX®

Experimental: Part B: Alisertib 50 mg
Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21 day cycles until disease progression or unacceptable toxicity.
Drug: Alisertib
Alisertib tablets




Primary Outcome Measures :
  1. Cmax: Maximum Observed Concentration of Alisertib in Presence and Absence of Itraconazole in Part A [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    Maximum observed concentration (Cmax) is the peak concentration of a drug after administration, obtained directly from the concentration-time curve.

  2. 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 [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    AUC is a measure of the area under the curve over the dosing interval.

  3. 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 [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    AUC is a measure of the area under the curve over the dosing interval.


Secondary Outcome Measures :
  1. CL/F: Oral Clearance of Alisertib in Presence and Absence of Itraconazole in Part A [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    CL/F is apparent clearance of the drug from the plasma, calculated as the drug dose divided AUC(0-##), expressed in Liters/hour.

  2. Tmax:Time to Achieve Maximum Plasma Concentration of Alisertib in Presence and Absence of Itraconazole in Part A [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    Tmax: Time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax.

  3. T½: Terminal Phase Elimination Half-Life of Alisertib in Presence and Absence of Itraconazole in Part A [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    Terminal phase elimination half-life (T½) is the time required for half of the drug to be eliminated from the blood.

  4. Cmax of Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
  5. Tmax of Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

  6. AUC(0-last) of Alisertib metabolites M1 and M2 of Alisertib in Presence and Absence of Itraconazole in Part A [ Time Frame: Day 1 and Day 10 (pre-dose and multiple time-points post-dose up to 96 hours) ]
    AUC is a measure of the area under the curve over the dosing interval.

  7. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Day 1 to 30 Days post last dose ]

    An AE is considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

    A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.


  8. Number of Participants with Markedly Abnormal Laboratory Values [ Time Frame: Day 1 to 30 Days post last dose ]
    The number of participants with any markedly abnormal standard safety laboratory values is collected throughout study.

  9. Change from Baseline in Weight [ Time Frame: Day 1 to 30 Days post last dose ]
    Change relative to Baseline in participant's weight measured throughout study.

  10. Change from Baseline in Vital Sign Measurements [ Time Frame: Day 1 to 30 Days Post Last Dose ]
    Vital signs will include body temperature (oral), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259010


Locations
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United States, Missouri
St. Louis, Missouri, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Tennessee
Germantown, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.

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Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02259010     History of Changes
Other Study ID Numbers: C14020
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors