A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies

Completed · Phase 1

Conditions studied: Advanced Nonhematologic Malignancies

In brief

The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117. It also evaluated the single- and multiple-dose plasma pharmacokinetics (PK) of TAK-228+TAK-117 in participants with advanced nonhematologic malignancies.

Key facts

Study ID: NCT01899053
Run by: Millennium Pharmaceuticals, Inc.
People needed: 101
Starts: 2013-06-28
Expected to finish: 2018-04-30
Last updated by the study team: 2019-10-30

Who can join

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

You may qualify if…

Male or female participants 18 years or older
Participants must have a diagnosis and documented disease progression of a solid tumor malignancy, excluding primary brain tumor, for which standard, curative, or life prolonging treatment does not exist or is no longer effective
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Female participants who are postmenopausal for at least 1 year prior to screening. For women of child-bearing potential agree to practice 2 effective methods of contraception or agree to practice true abstinence
Male participants must agree to practice effective barrier contraception during the entire study treatment period and through 30 days after last dose of study drug or practice true abstinence
Voluntary written consent
Suitable venous access
Participants must have a block of banked tumor tissue and/or fresh tumor tissue or at least 10 unstained slides available to be sent to the central laboratory
Clinical laboratory values as specified in the protocol
Participants must have radiographically or clinically evaluable tumor

You may not qualify if…

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
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
Treatment with any investigational products within 30 days before the first dose of study drug
Previous treatment with TAK-117 and/or TAK-228; previous treatment with dual mTORC1/2 or dual PI3K-mTOR inhibitors
Failed to have recovered from the reversible effects of previous anticancer therapies
Have received systemic corticosteroid (inhalers are allowed) within 7 days before the first administration of study drug
Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of study drug
Diagnosis of diabetes mellitus
Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active CNS disease, active infection
Known human immunodeficiency virus (HIV) infection
Cardiovascular conditions as defined in the protocol
A requirement for positive inotropic support (excluding digoxin) or serious uncontrolled cardiac arrhythmia (including atrial flutter/fibrillation) within 1 year before screening
Participants who are taking proton pump inhibitors within 7 days of the first dose or who require treatment with proton pump inhibitors during the trial or those who are taking histamine-2 (H2) receptor antagonists within 24 hours of the first dose
Participants who received previous therapy with PI3K inhibitors or rapalogs will be allowed in the study if all other inclusion/exclusion criteria are met
Diagnosis of primary brain tumor or symptomatic brain metastasis. Participants with brain metastases must be without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs)

Where it is running

Study site — Boston, Massachusetts, United States
Study site — Nashville, Tennessee, United States
Study site — San Antonio, Texas, United States
Study site — Barcelona, Spain
Study site — Sutton, United Kingdom

Full record on ClinicalTrials.gov

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