Clinical trial · Interventional
Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies
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
NCT01613261CI-TRIAL-00012513withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Multicenter, Open-label, Phase 1b Study of TAK-733 in Combination With Alisertib in Adult Patients With Advanced Nonhematologic Malignancies
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Nonhematologic Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAK-733 and alisertib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAK-733 and alisertib
- interventionNames
- Drug: TAK-733 and alisertib
Primary outcomes (2)
- measure
- Number of Adverse Events (AEs), Serious Adverse Events (SAEs), assessments of clinical laboratory values, and vital sign measurements
- timeFrame
- From signing of the informed consent form through 30 days after the last dose of study drug
- description
- To evaluate the safety profile and to determine DLTs, MTDs, and RP2D of oral TAK-733 + alisertib in patients with advanced nonhematologic malignancies
- measure
- 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
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.