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

NCT01613261 | Withdrawn Phase 1

• 2 other identifiers: C200022012-000831-22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Nonhematologic Malignancies

Keywords

TAK-733,; alisertib,; MLN8237,; Oral MEK Inhibitor,; Oral Aurora A Kinase Inhibitor

Outcome Measures

Primary Outcomes (2)

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

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

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

• 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

  To characterize the single- and multiple-dose plasma PK of TAK-733 and alisertib in patients with advanced nonhematologic malignancies

  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

Secondary Outcomes (1)

• Measures of disease response, including objective response rate and duration of response based on investigator's assessment using RECIST guidelines

  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

Study Arms (1)

TAK-733 and alisertib

EXPERIMENTAL

Drug: TAK-733 and alisertib

Interventions

TAK-733 and alisertib DRUG

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.

TAK-733 and alisertib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

TAK 733; MLN 8237

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2012
• First Posted: June 7, 2012
• Study Start: August 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (1)