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A Multicenter, Open-label, Phase 1b Study of TAK-733 (an Oral MEK Inhibitor) in Combination With Alisertib (an Oral Aurora A Kinase Inhibitor) in Adult Patients With Advanced Nonhematologic Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Nonhematologic Malignancies

Thank you

Trial Information

A Multicenter, Open-label, Phase 1b Study of TAK-733 (an Oral MEK Inhibitor) in Combination With Alisertib (an Oral Aurora A Kinase Inhibitor) in Adult Patients With Advanced Nonhematologic Malignancies


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Adverse Events (AEs), Serious Adverse Events (SAEs), assessments of clinical laboratory values, and vital sign measurements

Outcome Description:

To evaluate the safety profile and to determine DLTs, MTDs, and RP2D of oral TAK-733 + alisertib in patients with advanced nonhematologic malignancies

Outcome Time Frame:

From signing of the informed consent form through 30 days after the last dose of study drug

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C20002

NCT ID:

NCT01613261

Start Date:

June 2013

Completion Date:

Related Keywords:

  • Advanced Nonhematologic Malignancies
  • TAK-733,
  • alisertib,
  • MLN8237,
  • Oral MEK Inhibitor,
  • Oral Aurora A Kinase Inhibitor
  • Neoplasms

Name

Location

South Texas Accelerated Research Therapeutics (START)San Antonio, Texas  78229