Clinical Trials

MK-2206 dihydrochloride has been evaluated in numerous clinical trials, predominantly Phase 1 and Phase 2 studies, targeting diverse malignancies such as advanced solid tumors, relapsed or refractory lymphomas, renal cell carcinoma, non-small-cell lung cancer, and various breast cancer subtypes. Supported by diverse sponsors—including government bodies like the National Cancer Institute, research collaboratives, academic institutions, and industry partners like Merck Sharp & Dohme—these studies span recruitment statuses including completed, active not recruiting, recruiting, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01042379 RECRUITING
Breast Neoplasms; Breast Cancer; Breast Tumors; Angiosarcoma; TNBC - Triple-Negative Breast Cancer; HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer
QuantumLeap Healthcare Collaborative
 2010-03-01 PHASE2
NCT01248247 COMPLETED
Lung Cancer
M.D. Anderson Cancer Center
 2011-06-02 PHASE2
NCT01480154 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Stage III Cutaneous Melanoma AJCC v7; Stage III Prostate Cancer AJCC v7; Stage III Renal Cell Cancer AJCC v7; Stage IIIA Cutaneous Melanoma AJCC v7; Stage IIIB Cutaneous Melanoma AJCC v7; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Stage IV Prostate Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
 2011-11-23 PHASE1
NCT01239342 TERMINATED
Metastatic Kidney Carcinoma; Recurrent Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
 2011-01-27 PHASE2
NCT01251861 COMPLETED
Recurrent Prostate Carcinoma; Stage I Prostate Cancer AJCC v7; Stage IIA Prostate Cancer AJCC v7; Stage IIB Prostate Cancer AJCC v7; Stage III Prostate Cancer AJCC v7
National Cancer Institute (NCI)
 2011-03-17 PHASE2
NCT01370070 COMPLETED
Recurrent Nasopharyngeal Carcinoma
Chinese University of Hong Kong
 2011-07 PHASE2
NCT01783171 COMPLETED
Pancreatic Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IV Pancreatic Cancer AJCC v6 and v7; Unresectable Pancreatic Carcinoma
National Cancer Institute (NCI)
 2013-01-15 PHASE1
NCT01307631 COMPLETED
Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Recurrent Uterine Corpus Carcinoma
National Cancer Institute (NCI)
 2011-03 PHASE2
NCT01294306 COMPLETED
Adenosquamous Lung Carcinoma; Bronchioloalveolar Carcinoma; Large Cell Lung Carcinoma; Lung Adenocarcinoma; Recurrent Non-Small Cell Lung Carcinoma; Squamous Cell Lung Carcinoma
National Cancer Institute (NCI)
 2011-02 PHASE2
NCT01802320 COMPLETED
Colon Mucinous Adenocarcinoma; Colon Signet Ring Cell Adenocarcinoma; Rectal Mucinous Adenocarcinoma; Rectal Signet Ring Cell Adenocarcinoma; Recurrent Colon Carcinoma; Recurrent Rectal Carcinoma; Stage IIIA Colon Cancer; Stage IIIA Rectal Cancer; Stage IIIB Colon Cancer; Stage IIIB Rectal Cancer; Stage IIIC Colon Cancer; Stage IIIC Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer
National Cancer Institute (NCI)
 2013-03 PHASE2
NCT01658943 COMPLETED
Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer
National Cancer Institute (NCI)
 2012-08 PHASE2
NCT01776008 TERMINATED
Estrogen Receptor Positive; HER2/Neu Negative; Recurrent Breast Carcinoma; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
National Cancer Institute (NCI)
 2013-01 PHASE2
NCT01714128 WITHDRAWN
Breast Cancer
Washington University School of Medicine
 2013-06
NCT01283035 COMPLETED
Ovarian Sarcoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
National Cancer Institute (NCI)
 2011-04 PHASE2
NCT01245205 COMPLETED
HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Unspecified Adult Solid Tumor, Protocol Specific
National Cancer Institute (NCI)
 2010-11 PHASE1
NCT01277757 COMPLETED
Recurrent Breast Carcinoma; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
 2011-03 PHASE2
NCT01258998 COMPLETED
Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; B-cell Adult Acute Lymphoblastic Leukemia; B-cell Chronic Lymphocytic Leukemia; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Refractory Hairy Cell Leukemia; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; T-cell Adult Acute Lymphoblastic Leukemia; T-cell Large Granular Lymphocyte Leukemia; Testicular Lymphoma; Waldenström Macroglobulinemia
National Cancer Institute (NCI)
 2010-12 PHASE2
NCT01260701 COMPLETED
Adenocarcinoma of the Gastroesophageal Junction; Diffuse Gastric Adenocarcinoma; Gastric Intestinal Type Adenocarcinoma; Gastric Mixed Adenocarcinoma; Recurrent Gastric Carcinoma
National Cancer Institute (NCI)
 2011-01 PHASE2
NCT01306045 COMPLETED
Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell Lung; Carcinoma, Thymic
National Cancer Institute (NCI)
 2011-02-08 PHASE2
NCT01369849 COMPLETED
Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia
National Cancer Institute (NCI)
 2011-09 PHASE1; PHASE2
NCT01169649 COMPLETED
PANCREAS; Neuroendocrine
Memorial Sloan Kettering Cancer Center
 2010-07 PHASE2
NCT01281163 TERMINATED
Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Positive; Progesterone Receptor Negative; Progesterone Receptor Positive; Recurrent Breast Carcinoma; Stage IV Breast Cancer
National Cancer Institute (NCI)
 2011-01 PHASE1
NCT01295632 COMPLETED
Advanced Cancer
Merck Sharp & Dohme LLC
 2011-02 PHASE1
NCT01333475 COMPLETED
Colorectal Neoplasms
National Cancer Institute (NCI)
 2011-03 PHASE2
NCT01604772 COMPLETED
Recurrent Oral Cavity Adenoid Cystic Carcinoma; Recurrent Salivary Gland Carcinoma; Salivary Gland Adenoid Cystic Carcinoma; Stage IVA Major Salivary Gland Cancer AJCC v7; Stage IVA Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7; Stage IVB Major Salivary Gland Cancer AJCC v7; Stage IVB Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7; Stage IVC Major Salivary Gland Cancer AJCC v7; Stage IVC Oral Cavity Adenoid Cystic Carcinoma AJCC v6 and v7
National Cancer Institute (NCI)
 2012-07-23 PHASE2
NCT01253447 COMPLETED
Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia
National Cancer Institute (NCI)
 2010-10 PHASE2
NCT01349933 COMPLETED
Recurrent Squamous Cell Carcinoma of the Nasopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx
National Cancer Institute (NCI)
 2011-04 PHASE2
NCT01466868 TERMINATED
Diffuse Large B Cell Lymphoma
Centre Leon Berard
 2011-11 PHASE2
NCT01147211 UNKNOWN
Non Small Cell Lung Cancer
National Taiwan University Hospital
 2010-09 PHASE1
NCT01319539 TERMINATED
Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; HER2/Neu Positive; Progesterone Receptor Negative; Progesterone Receptor Positive; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Triple-Negative Breast Carcinoma
National Cancer Institute (NCI)
 2011-04 PHASE2
NCT01481129 COMPLETED
Diffuse Large B Cell Lymphoma
National Cancer Institute (NCI)
 2011-12 PHASE2
NCT01859182 WITHDRAWN
Adenocarcinoma of the Gallbladder; Adenocarcinoma With Squamous Metaplasia of the Gallbladder; Adult Primary Cholangiocellular Carcinoma; Advanced Adult Primary Liver Cancer; Cholangiocarcinoma of the Extrahepatic Bile Duct; Localized Unresectable Adult Primary Liver Cancer; Metastatic Extrahepatic Bile Duct Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Stage II Gallbladder Cancer; Stage IIIA Gallbladder Cancer; Stage IIIB Gallbladder Cancer; Stage IVA Gallbladder Cancer; Stage IVB Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer
National Cancer Institute (NCI)
 2013-01 PHASE2
NCT01425879 COMPLETED
Advanced Adult Hepatocellular Carcinoma; Localized Non-Resectable Adult Liver Carcinoma; Recurrent Adult Liver Carcinoma; Recurrent Gallbladder Carcinoma; Stage IV Distal Bile Duct Cancer; Stage IV Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Carcinoma; Unresectable Gallbladder Carcinoma
National Cancer Institute (NCI)
 2011-04 PHASE2
NCT01705340 TERMINATED
Adenocarcinoma of the Gastroesophageal Junction; HER2-positive Breast Cancer; Male Breast Cancer; Recurrent Breast Cancer; Recurrent Esophageal Cancer; Recurrent Gastric Cancer; Stage IIIC Breast Cancer; Stage IIIC Esophageal Cancer; Stage IIIC Gastric Cancer; Stage IV Breast Cancer; Stage IV Esophageal Cancer; Stage IV Gastric Cancer
National Cancer Institute (NCI)
 2012-09 PHASE1
NCT01519427 TERMINATED
Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
 2012-01 PHASE2
NCT01231919 COMPLETED
Accelerated Phase Chronic Myelogenous Leukemia; Acute Leukemias of Ambiguous Lineage; Acute Myeloid Leukemia/Transient Myeloproliferative Disorder; Acute Undifferentiated Leukemia; Aggressive NK-cell Leukemia; Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative; Blastic Phase Chronic Myelogenous Leukemia; Blastic Plasmacytoid Dendritic Cell Neoplasm; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Grade III Lymphomatoid Granulomatosis; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Chronic Eosinophilic Leukemia; Chronic Myelomonocytic Leukemia; Chronic Neutrophilic Leukemia; Chronic Phase Chronic Myelogenous Leukemia; Intraocular Lymphoma; Juvenile Myelomonocytic Leukemia; Mast Cell Leukemia; Myeloid/NK-cell Acute Leukemia; Noncutaneous Extranodal Lymphoma; Post-transplant Lymphoproliferative Disorder; Primary Central Nervous System Hodgkin Lymphoma; Primary Central Nervous System Non-Hodgkin Lymphoma; Progressive Hairy Cell Leukemia, Initial Treatment; Prolymphocytic Leukemia; Recurrent Childhood Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Hairy Cell Leukemia; Relapsing Chronic Myelogenous Leukemia; Secondary Acute Myeloid Leukemia; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Unspecified Childhood Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia
National Cancer Institute (NCI)
 2011-01 PHASE1
NCT01235897 COMPLETED
Advanced Solid Tumors; Tumors; Cancer
University of California, San Francisco
 2011-03 PHASE1
NCT01239355 TERMINATED
Adult Hepatocellular Carcinoma; Advanced Adult Hepatocellular Carcinoma; Localized Non-Resectable Adult Liver Carcinoma; Recurrent Adult Liver Carcinoma
National Cancer Institute (NCI)
 2010-12 PHASE2
NCT01243762 TERMINATED
Neoplasms Malignant
Merck Sharp & Dohme LLC
 2010-11-22 PHASE1
NCT01021748 COMPLETED
Locally Advanced or Metastatic Solid Tumors
Merck Sharp & Dohme LLC
 2009-11-23 PHASE1
NCT01263145 COMPLETED
Adult Solid Neoplasm; Recurrent Breast Carcinoma; Stage IV Breast Cancer
National Cancer Institute (NCI)
 2011-01-05 PHASE1
NCT01240941 WITHDRAWN
Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
 2011-02 PHASE2
NCT01480154 Active not recruiting
Advanced Malignant Solid Neoplasm|Stage III Cutaneous Melanoma AJCC v7|Stage III Prostate Cancer AJCC v7|Stage III Renal Cell Cancer AJCC v7|Stage IIIA Cutaneous Melanoma AJCC v7|Stage IIIB Cutaneous Melanoma AJCC v7|Stage IIIC Cutaneous Melanoma AJCC v7|Stage IV Cutaneous Melanoma AJCC v6 and v7|Stage IV Prostate Cancer AJCC v7|Stage IV Renal Cell Cancer AJCC v7
National Cancer Institute (NCI)
 2011-11-23 Phase 1
NCT01466868 Terminated
Diffuse Large B Cell Lymphoma
Centre Leon Berard|National Cancer Institute France
 2011-11 Phase 2
NCT01071018 COMPLETED
Solid Tumors
Merck Sharp & Dohme LLC
 2010-02 PHASE1
NCT00963547 TERMINATED
Advanced Solid Tumors; Breast Cancer
Merck Sharp & Dohme LLC
 2009-09-15 PHASE1
NCT01186705 TERMINATED
Colon Cancer; Rectal Cancer
Memorial Sloan Kettering Cancer Center
 2010-08 PHASE2
NCT00670488 COMPLETED
Locally Advanced Tumors; Metastatic Solid Tumors; Cancer; Neoplasms
Merck Sharp & Dohme LLC
 2008-04-15 PHASE1
NCT01344031 COMPLETED
Estrogen Receptor Positive; Invasive Breast Carcinoma; Recurrent Breast Carcinoma; Stage IV Breast Cancer AJCC v6 and v7
National Cancer Institute (NCI)
 2011-04-21 PHASE1
NCT00848718 COMPLETED
Locally Advanced, Metastatic Solid Tumors
Merck Sharp & Dohme LLC
 2009-03-17 PHASE1
NCT01240928 WITHDRAWN
Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
 PHASE1
NCT01249105 WITHDRAWN
Malignant Glioma
Dana-Farber Cancer Institute
 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-06)

Check the MK-2206 Dihydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MK-2206 dihydrochloride is a potent, non-ATP competitive allosteric inhibitor that binds selectively to Akt1, Akt2, and Akt3 isoforms, thereby blocking downstream Akt phosphorylation and pro-survival signaling cascades. Inhibition of this pathway induces autophagy and apoptosis while enhancing cellular radiosensitivity and chemosensitivity, ultimately suppressing tumor growth in clinical target indications such as advanced solid tumors, breast cancer, and hematologic malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Jump to

Note: Technical data last updated: Sep 1, 2026.