Status:
COMPLETED
A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Conditions:
Advanced Nonhematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
The drug being tested in this study was TAK-228. TAK-228 was tested to evaluate the safety, pharmacokinetics and efficacy, of TAK-228 in combination with TAK-117 when administered to adult participant...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01899053
Start Date
June 28 2013
End Date
April 30 2018
Last Update
October 30 2019
Active Locations (5)
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1
Boston, Massachusetts, United States
2
Nashville, Tennessee, United States
3
San Antonio, Texas, United States
4
Barcelona, Spain