Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies
NCT ID: NCT01613261
Last Updated: 2013-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2013-08-31
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAK-733 and alisertib
TAK-733 and alisertib
TAK-733 will be administered orally once daily (QD) on Days 1 through 14 of the 21-day cycle.
Alisertib will be administered orally twice daily (BID) on Days 1 through 7 of the 21-day cycle.
Interventions
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TAK-733 and alisertib
TAK-733 will be administered orally once daily (QD) on Days 1 through 14 of the 21-day cycle.
Alisertib will be administered orally twice daily (BID) on Days 1 through 7 of the 21-day cycle.
Eligibility Criteria
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Inclusion Criteria
* Patients must have a diagnosis of a solid tumor malignancy for which standard, curative, or life-prolonging treatment does not exist or is no longer effective
* Radiographically or clinically evaluable tumor
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
* Female patients who are post menopausal for at least 1 year, surgically sterile, or agree to practice 2 effective methods of contraception through 30 days after the last dose of study drug or agree to abstain from heterosexual intercourse
* Male patients who agree to practice effective barrier contraception through 4 months after the last dose of alisertib or agree to abstain from heterosexual intercourse
* Voluntary written consent
* Clinical laboratory values as specified in the protocol
Exclusion Criteria
* Serious medical or psychiatric illness or laboratory abnormality that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
* Treatment with any investigational products within 28 days before the first dose of study drug
* Prior treatment with Aurora A-targeted agents, including alisertib
* Prior treatment with MEK inhibitors, including TAK-733
* Prior treatment with BRAF inhibitors
* Systemic anticancer therapy within 21 days before the first dose
* Prior biologic or immunotherapy within 28 days before the first dose
* Major surgery or serious infection within 14 days before the first dose
* Life-threatening illness unrelated to cancer
* Known active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C
* Cardiac condition as specified in study protocol or severe CNS, pulmonary, renal or hepatic disease
* Known GI conditions or GI procedure that could interfere with the oral absorption or tolerance of study drugs
* History of uncontrolled sleep apnea syndrome or other conditions that could result in excessive daytime sleepiness
* History of ongoing or a newly diagnosed eye abnormality
* Symptomatic brain metastases
Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons
18 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Countries
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Other Identifiers
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2012-000831-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C20002
Identifier Type: -
Identifier Source: org_study_id