Clinical trial · Interventional
Dose Escalation Study of TAK-117 (MLN1117) in Subjects With Advanced Cancer
A Phase I, Dose Escalation Study of MLN1117 in Subjects With Advanced Solid Malignancies Followed by Expansion in Subjects With Measurable Disease
NCT01449370CI-TRIAL-00026364completedPhase 1Results postedClinicalTrials.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)
The purpose of this study is to determine the maximum tolerated dose (MTD) and/or optimal biologic dose(OBD), safety and tolerability, dose-limiting toxicity (DLT) of TAK-117 when administered orally in subjects with advanced solid 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 |
|---|---|---|---|
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAK-117 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- TAK-117 administered once a day orally
- interventionNames
- Drug: TAK-117
- type
- EXPERIMENTAL
- label
- Arm B
- description
- TAK-117 administered orally intermittently, once every other day (Monday, Wednesday, and Friday) each week
- interventionNames
- Drug: TAK-117
- type
- EXPERIMENTAL
- label
- Arm C
- description
- TAK-117 administered orally intermittently, once a day for 3 consecutive days (Monday, Tuesday, and Wednesday) each week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects have had their PIK3CA gene mutation status assessed prior to enrolling into the study * Subjects must have documented disease progression prior to enrolling into the study * locally advanced or metastatic solid tumors with the exception of primary brain tumor, and have failed or are not eligible for standard of care therapy. * Age greater than or equal to (\>=) 18 years, including males and females; * Eastern cooperative oncology group (ECOG) performance status (PS) 0-1; * Adequate organ function; * Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration; * Ability to swallow oral medications; * Ability to understand and willingness to sign informed consent prior to initiation of any study procedures; * For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration Exclusion Criteria: * Diagnosis of primary brain tumor; untreated brain metastasis or history of leptomeningeal disease or spinal cord compression; * Received prior cancer or other investigational therapy within 2 weeks prior to the first administration of study drug; * Have received a systemic corticosteroid within one week prior to the first administration of study drug; * Clinically significant cardiac disease; * Myocardial infarction or unstable angina within 6 months prior to the first administration of study drug; * Malabsorption ; * Poorly controlled diabetes mellitus; * Pregnancy (positive serum or urine pregnancy test) or breast feeding; * Untreated brain metastasis or history of leptomeningeal disease or spinal cord compression; * Failed to recover from the reversible effects of prior anticancer therapies; * Have received a selective phosphoinositide-3-kinase alpha isoform (PI3K-alpha) inhibitor * Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system (CNS) disease, active infection, or any other condition that could compromise the subject's participation in the study * Known human immunodeficiency virus (HIV) infection * Have a secondary malignancy within the last 3 years prior to first dose of study drug, excluding treated non-melanoma skin cancer, carcinoma in situ, or locally-treated prostate cancer
References
Publications (0)
Data not yet available
No reference posted for this study.