drugset / Trial / NCT00670488
Dose Escalation Study With MK-2206 in Patients With Locally Advanced or Metastatic Solid Tumors (MK-2206-002)
Non-randomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2008-04-15
- Primary completion
- 2011-07-11
- Completion
- 2011-07-11
Publications
- Results Yap 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.
- Yap 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MK-2206 | Small molecule | 30 mg | Oral |
| Subject | MK-2206 | Small molecule | 60 mg | Oral |
| Subject | MK-2206 | Small molecule | 75 mg | Oral |
| Subject | MK-2206 | Small molecule | 90 mg | Oral |
| Subject | MK-2206 | Small molecule | 135 mg | Oral |
| Subject | MK-2206 | Small molecule | 150 mg | Oral |
| Subject | MK-2206 | Small molecule | 200 mg | Oral |
| Subject | MK-2206 | Small molecule | 250 mg | Oral |
| Subject | MK-2206 | Small molecule | 300 mg | Oral |