NCT02259010

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2014

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
14 days until next milestone

Study Start

First participant enrolled

October 22, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2015

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

September 20, 2019

Completed
Last Updated

September 20, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

October 3, 2014

Results QC Date

April 9, 2018

Last Update Submit

August 16, 2019

Conditions

Advanced Solid TumorsRelapsed/Refractory Lymphoma

Outcome Measures

Primary Outcomes (3)

  • Cmax: Maximum Observed Concentration of Alisertib in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

  • AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

  • AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

Secondary Outcomes (10)

  • CL/F: Oral Clearance of Alisertib in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

  • Tmax: Time to Reach Maximum Plasma Concentration of Alisertib in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

  • Terminal Phase Elimination Half-Life of Alisertib in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

  • Cmax: Maximum Observed Plasma Concentration for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

  • Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alisertib Metabolites M1 and M2 in Presence and Absence of Itraconazole in Part A

    Day 1 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib without itraconazole arm; Day 10 pre-dose and at multiple time points (up to 96 hours) post-dose in Cycle 1 for alisertib with itraconazole arm

  • +5 more secondary outcomes

Study Arms (1)

Part A: Alisertib 30 mg+Itraconazole; Part B: Alisertib 50 mg

EXPERIMENTAL

All participants were to complete Part A prior to Part B. Part A: Alisertib 30 mg, tablets, orally, on Days 1 and 10 plus itraconazole, 200 mg, oral solution, once daily on Days 5 to 13. Part A and B were separated by a washout period of at least 10 days (and up to 4 weeks). Part B: Alisertib 50 mg, tablets, orally, twice daily, for 7 days in 21-day cycles until disease progression or unacceptable toxicity (up to 16 cycles).

Drug: AlisertibDrug: Itraconazole

Interventions

AlisertibDRUG

Alisertib tablets

Part A: Alisertib 30 mg+Itraconazole; Part B: Alisertib 50 mg
ItraconazoleDRUG

Itraconazole oral solution

Also known as: SPORANOX®
Part A: Alisertib 30 mg+Itraconazole; Part B: Alisertib 50 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female participants 18 years of age or older.
  • Participants with histologic or cytologic diagnosis of advanced or metastatic solid tumors or lymphomas for which no curative or life-prolonging therapies exist.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

  • 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).
  • 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.
  • Known hypersensitivity or intolerance to itraconazole or similar class agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Oklahoma City, Oklahoma, United States

Location

Unknown Facility

Germantown, Tennessee, United States

Location

Unknown Facility

Dallas, Texas, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

MLN 8237Itraconazole

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Results Point of Contact

Title
Medical Director
Organization
Takeda
trialdisclosures@takeda.com
+1-877-825-3327

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 8, 2014

Study Start

October 22, 2014

Primary Completion

March 27, 2015

Study Completion

October 21, 2016

Last Updated

September 20, 2019

Results First Posted

September 20, 2019

Record last verified: 2019-08

Locations

US(4)