Clinical trial · Interventional
A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)
A Phase I Study of MK2206 in Patients With Locally Advanced or Metastatic Solid Tumors
NCT01071018CI-TRIAL-00019053completedPhase 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 study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK2206 every other day | Drug | — | UNRESOLVED |
| MK2206 once weekly | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- QOD Schedule
- description
- QOD Schedule, MK2206 every other day
- interventionNames
- Drug: MK2206 every other day
- type
- EXPERIMENTAL
- label
- QW Schedule
- description
- QW Schedule, MK2206 once weekly
- interventionNames
- Drug: MK2206 once weekly
Primary outcomes (1)
- measure
- Characterize safety and tolerability of MK2206 by monitoring incidence of protocol-defined dose limiting toxicities (DLTs)
- timeFrame
- Day 1 - Day 28 (Cycle 1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy * Has adequate organ function * Is ECOG Performance Scale 0-1 * Has a negative urine pregnancy test if patient is female * Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis Exclusion Criteria: * Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment * Is currently participating or has participated in a study with an investigational compound or device within 28 days * Has a primary central nervous system tumor * Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure * Is a known diabetic who is taking insulin or oral antidiabetic therapy * Is pregnant or breastfeeding or planning to become pregnant during the study * Is positive HIV antibody, HBs antigen or HCV antibody
References
Publications (1)
- BACKGROUNDDoi T, Tamura K, Tanabe Y, Yonemori K, Yoshino T, Fuse N, Kodaira M, Bando H, Noguchi K, Shimamoto T, Ohtsu A. Phase 1 pharmacokinetic study of the oral pan-AKT inhibitor MK-2206 in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Aug;76(2):409-16. doi: 10.1007/s00280-015-2810-z. Epub 2015 Jun 24. PMID 26104654