A Dose Escalation Study of MLN7243 (TAK-243) in Adult Participants With Advanced Solid Tumors

Stopped early · Phase 1

Conditions studied: Advanced Malignant Solid Tumors

In brief

The purpose of this study is to evaluate safety and tolerability (establish maximum tolerated dose \[MTD\], inform the recommended phase 2 dose \[RP2D\], and identify the dose-limiting toxicities \[DLTs\]) of MLN7243.

Key facts

Study ID

NCT02045095

Run by

Millennium Pharmaceuticals, Inc.

People needed

29

Starts

2014-01-31

Expected to finish

2016-11-09

Last updated by the study team

2019-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each participant must meet all of the following inclusion criteria to be enrolled in the study:
• Male or female participants 18 years or older.
• Participants must have a histologically confirmed diagnosis of an advanced, metastatic malignant solid tumor and must have failed or exhausted standard therapies or for which no standard therapy is available.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participants with adequate hematologic and organ function.
• All participants must have radiographically detectable tumors with measurable disease as defined by RECIST (version 1.1).
• Participants undergoing a biopsy procedure must have accessible lesions which are safe to biopsy.
• Recovered (that is, less than or equal to (<=) Grade 1 toxicity) from the reversible effects of prior antineoplastic therapy, except alopecia.
• Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 4 months after the last dose of study drug, or agree to practice true abstinence.
• Male participants who agree to practice effective barrier contraception during the entire study treatment period through 4 months after the last dose of study drug or agree to practice true abstinence.
• Suitable venous access for the study-required blood sampling including PK sampling.

You may not qualify if…

• Participants meeting any of the following exclusion criteria are not to be enrolled in the study:
• Participants with clinically significant pre-existing cardiac impairment.
• Participants homozygous for the ABCG2 (BCRP) c.421C greater than (>) 1 A polymorphism will be excluded from the study until the safety of a minimum of the first 3 dose levels has been characterized and the sponsor confirms that such participants can be enrolled at doses that are at least 3-fold lower than the most recently determined safe and tolerable dose among at least 3 dose limiting toxicities (DLT)-evaluable non-homozygous participants.
• Participants with known active central nervous system (CNS) lesions are excluded. Systemic antineoplastic therapy or investigational agents within 21 days before the first dose of study drug.
• Radiotherapy within 14 days before the first dose of study drug is not allowed except for limited field radiotherapy for palliative bone pain.
• For participants where tumor biopsies are required or requested:
• Any known coagulation abnormalities that would contraindicate the tumor biopsy procedure.
• Ongoing therapy with any anticoagulant or antiplatelet agents (example, aspirin, clopidogrel [Plavix®], heparin, or warfarin).
• Major surgery within 28 days before the first dose of MLN7243.
• Life-threatening illness unrelated to cancer.
• Any evidence of active infection or antibiotic therapy within 14 days before the first dose of MLN7243.
• Known human immunodeficiency virus (HIV) positivity or AIDS-related illness, hepatitis B virus, and hepatitis C virus.
• Participants whose weight is less than (<) 40 kilogram (kg).
• History of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease.
• Female participants who are lactating and breastfeeding or have a positive serum pregnancy test during the Screening period or a positive urine pregnancy test on Day 1 before first dose of study drug.

Where it is running

• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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