Food Effect Study of Alisertib (MLN8237) in Participants With Advanced Solid Tumors or Lymphomas

NCT01898078 | Completed Phase 1 Results FDA Drug

• 1 other identifier: C14017
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effect of food on the single-dose pharmacokinetics (PK) of alisertib administered as an enteric-coated tablet (ECT) formulation in participants with advanced solid tumors or lymphomas.

Conditions

Advanced Solid Tumors; Lymphoma

Keywords

MLN8237; Alisertib; Food effects

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration of Alisertib

  Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• AUC(Last): Area Under the Plasma Concentration Curve From Time 0 to the Time of the Last Quantifiable Concentration of Alisertib

  Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

• AUC∞: Area Under the Plasma Concentration Curve From Time 0 to Infinity of Alisertib

  Cycles 1 and 2, Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary Outcomes (3)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From first dose through 30 days after the last dose of study drug (up to 225 days)

• Number of Participants With Clinically Significant Change in Laboratory Parameters Reported as AEs

  From first dose through 30 days after the last dose of study drug (up to 225 days)

• Number of Participants With Clinically Significant Change in Vital Sign Reported as AEs

  From first dose through 30 days after the last dose of study drug (up to 225 days)

Study Arms (2)

Alisertib 50 mg Fed + Fasted

EXPERIMENTAL

Alisertib 50 mg, enteric-coated tablets (ECT), orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, twice daily (BID) on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.

Drug: Alisertib

Alisertib 50 mg Fasted + Fed

EXPERIMENTAL

Alisertib 50 mg, ECT, orally, in fasted state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 1 (24-day cycles), followed by alisertib 50 mg, ECT, orally, in fed state, once on Day 1, followed by alisertib 50 mg, ECT, orally, BID on Days 4 through 10, followed by a 14-day rest period in Cycle 2, followed by alisertib 50 mg, ECT, orally, BID on Days 1-7, followed by a 14-day rest period in Cycle 3 and onwards (21-day cycles) until disease progression, occurrence of an unacceptable alisertib-related toxicity.

Drug: Alisertib

Interventions

Alisertib DRUG

Alisertib ECT

Also known as: MLN8237

Alisertib 50 mg Fasted + Fed; Alisertib 50 mg Fed + Fasted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Histologically or cytologically confirmed advanced tumors or lymphomas for which standard curative or life-prolonging treatment does not exist, or is no longer effective or tolerable
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Participant must meet protocol-specified laboratory values
• Suitable venous access
• Female participants who are postmenopausal for at least 1 year OR are surgically sterile OR if of childbearing potential, agree to practice 2 effective methods of contraception at the same time or agree to practice true abstinence
• Male participants who agree to practice effective barrier contraception during the entire study and through 4 months after the last dose of study drug OR agree to practice true abstinence

You may not qualify if:

• Prior or current investigational therapies within 4 weeks before the first dose of alisertib
• Female participants who are lactating or pregnant
• Participant requiring treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine, or phenobarbital, or rifampin, rifabutin, rifapentine, or St. John's wort within 14 days before the first dose of alisertib and during the study
• Medical conditions requiring daily, chronic, or regular use of proton pump inhibitors (PPIs) within 7 days preceding the first dose of alisertib, or histamine (H2)-receptor antagonists
• Participant requiring systemic anticoagulation
• Ongoing nausea or vomiting that is Grade 2 or worse in intensity
• Known gastrointestinal (GI) disease or GI procedures that could interfere with the oral absorption, excretion, or tolerance of alisertib
• History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness such as severe chronic obstructive pulmonary disease
• Known or suspected human immunodeficiency virus (HIV) positive or hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
• Participant who are lactose-intolerant or are unwilling/unable to consume the protocol specified standardized high-fat breakfast

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (3)

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Nashville, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

MLN 8237

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 12, 2013
• Study Start: July 16, 2013
• Primary Completion: March 5, 2014
• Study Completion: January 24, 2017
• Last Updated: June 21, 2019
• Results First Posted: June 21, 2019

Record last verified: 2019-03

Locations

US (3)