Clinical trial · Interventional
Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)
A Phase I Dose Escalation Study of Oral MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors
NCT00670488CI-TRIAL-00037876completedPhase 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 primary purpose of this study is to investigate the Dose Limiting Toxicities (DLTs), pharmacokinetics (PK), and pharmacodynamics (PD) of MK-2206 administered orally to participants with advanced solid tumors. The preliminary efficacy of MK-2206 will also be investigated.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Locally Advanced Tumors | Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MK-2206 | Drug | Akt Inhibitor MK2206 | ALIAS |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- MK-2206 30 mg QOD
- description
- Participants receive 30 mg oral MK-2206 every other day (QOD) in repeating 4-week treatment cycles.
- interventionNames
- Drug: MK-2206
- type
- EXPERIMENTAL
- label
- MK-2206 60 mg QOD
- description
- Participants receive 60 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
- interventionNames
- Drug: MK-2206
- type
- EXPERIMENTAL
- label
- MK-2206 75 mg QOD
- description
- Participants receive 75 mg oral MK-2206 QOD in repeating 4-week treatment cycles.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participant 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 normal organ function; is no greater than 2 on the ECOG Performance Scale * Has a negative blood or urine pregnancy test within 72 hours of receiving the first dose of study drug if participant 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: * Participant 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 30 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 HIV-positive * Has known history of Hepatitis B or C or active Hepatitis A * Is receiving treatment with oral corticosteroids
References
Publications (2)
- RESULTYap TA, Yan L, Patnaik A, Fearen I, Olmos D, Papadopoulos K, Baird RD, Delgado L, Taylor A, Lupinacci L, Riisnaes R, Pope LL, Heaton SP, Thomas G, Garrett MD, Sullivan DM, de Bono JS, Tolcher AW. First-in-man clinical trial of the oral pan-AKT inhibitor MK-2206 in patients with advanced solid tumors. J Clin Oncol. 2011 Dec 10;29(35):4688-95. doi: 10.1200/JCO.2011.35.5263. Epub 2011 Oct 24. PMID 22025163
- DERIVEDYap TA, Yan L, Patnaik A, Tunariu N, Biondo A, Fearen I, Papadopoulos KP, Olmos D, Baird R, Delgado L, Tetteh E, Beckman RA, Lupinacci L, Riisnaes R, Decordova S, Heaton SP, Swales K, deSouza NM, Leach MO, Garrett MD, Sullivan DM, de Bono JS, Tolcher AW. Interrogating two schedules of the AKT inhibitor MK-2206 in patients with advanced solid tumors incorporating novel pharmacodynamic and functional imaging biomarkers. Clin Cancer Res. 2014 Nov 15;20(22):5672-85. doi: 10.1158/1078-0432.CCR-14-0868. Epub 2014 Sep 19. PMID 25239610