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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01613261
First received: June 1, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Advanced Nonhematologic Malignancies
Drug: TAK-733 and alisertib
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Number of Adverse Events (AEs), Serious Adverse Events (SAEs), assessments of clinical laboratory values, and vital sign measurements [ Time Frame: From signing of the informed consent form through 30 days after the last dose of study drug ] [ Designated as safety issue: Yes ]
    To evaluate the safety profile and to determine DLTs, MTDs, and RP2D of oral TAK-733 + alisertib in patients with advanced nonhematologic malignancies

  • TAK-733 and alisertib PK parameters including, but not limited to Cmax, Tmax, Area Under Curve (AUC), apparent oral clearance (CL/F), peak-to-trough ratio, and accumulation ratio [ Time Frame: Escalation and MTD Refinement: Cycle 1-Day 1, 2, 7, 8, 14,and 15; Tumor Expansion Cohort: Cycle 1-Day 1, 7, 8, and 15; Cycle 2-Day 1, 8,and 15; PK Expansion Cohort: Cycle 1-Day 1, 7, and 8; Cycle 2-Day 7, 14, and 15. Each cycle is a 21 days cycle ] [ Designated as safety issue: No ]
    To characterize the single- and multiple-dose plasma PK of TAK-733 and alisertib in patients with advanced nonhematologic malignancies


Secondary Outcome Measures:
  • Measures of disease response, including objective response rate and duration of response based on investigator's assessment using RECIST guidelines [ Time Frame: On screening; Cycle 2: between Day 15 and 21, and every third cycle thereafter (5,8,11 etc.) until progressive disease for approximately 1 year ] [ Designated as safety issue: No ]
    To evaluate evidence of antitumor activity of TAK-733 + alisertib


Enrollment: 0
Study Start Date: August 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAK-733 and alisertib Drug: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613261

Locations
United States, Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01613261     History of Changes
Other Study ID Numbers: C20002, 2012-000831-22
Study First Received: June 1, 2012
Last Updated: October 31, 2013
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines

Keywords provided by Millennium Pharmaceuticals, Inc.:
TAK-733,
alisertib,
MLN8237,
Oral MEK Inhibitor,
Oral Aurora A Kinase Inhibitor

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014