A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of MLN8237 in Japanese Subjects with Advanced Solid Tumors

Status

Unknown

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221283

Enrollment

Registered

2010-10-25

Start date

2010-10-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced solid tumor

Interventions

investigational material(s) Generic name etc : MLN8237 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Major inclusion criteria include the following: 1) Patients must have a diagnosis of a malignant solid tumor that is histologically or cytologically confirmed. 2) Patients with advanced solid tumor who are refractory to standard therapy, or for which no standard therapy is available. 3) Eastern Cooperative Oncology Group (ECOG) of 0 or 1

Exclusion criteria

Exclusion criteria: Major exclusion criteria include the following: 1) Prior treatment with Aurora kinase inhibitors 2) Prior transplantation of allogeneic bone marrow, stem cells, or other organs 3) Patients with diagnosed brain metastases which requires treatment or symptomatic brain metastases 4) Major surgery within 14 days prior to enrollment or not yet recovered from prior major surgery. 5) Serious infection or infection that requires intravenous antibiotics within 14 days prior to enrollment. 6) Simultaneously diagnosed with or treated for another malignancy, or having a clinical history of primary malignancy in another organ(s)

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026