Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies

Millennium Pharmaceuticals

Status and phase

Withdrawn

Phase 1

Conditions

Advanced Nonhematologic Malignancies

Treatments

Drug: TAK-733 and alisertib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01613261

2012-000831-22 (EudraCT Number)

C20002

Details and patient eligibility

About

This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients 18 years or older
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

Female patients who are breastfeeding and lactating or pregnant
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

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

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