| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-02186 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2010-0243 | Other Identifier | M D Anderson Cancer Center | |
| 8731 | Other Identifier | CTEP | |
| N01CM00039 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This phase II trial is studying how well AKT inhibitor MK-2206 works in treating patients with relapsed or refractory acute myeloid leukemia (AML). AKT inhibitor MK-2206 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Determine the proportion of patients achieving Morphologic Complete Response (CR), Morphologic CR with incomplete count recovery (CRp) or Partial Response (PR) as best response within 3 cycles of therapy with MK-2206.
SECONDARY OBJECTIVES:
I. Describe the disease-free survival of patients that achieve CR/CRp.
II. Determine the toxicity profile of single-agent MK-2206 in this patient population.
III. To determine the biologic effects of MK-2206 on leukemia cells.
OUTLINE:
Patients receive AKT inhibitor MK-2206 orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Akt inhibitor MK2206) | Experimental | Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Akt inhibitor MK2206 | Drug | 200 mg orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Response of CR, CRp, or PR | Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count >/= 1.0 x10^9/L, Platelet count >/= 100 x10^9/L; Bone marrow aspirate and biopsy: </= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count >/=1.0 x10^9/L, Platelet count >/= 100 x10^9/L, >/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts \ | 12 weeks of treatment |
| Number of Participants With Treatment-related Non-hematological Toxicity | Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0) | Up to 30 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Percentage Change in Apoptosis | Peripheral blood Acute Myeloid Leukemia (AML) cells (total 2 x 10^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marina Konopleva, MD, PHD | UT MD Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | United States | ||
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24583795 | Derived | Konopleva MY, Walter RB, Faderl SH, Jabbour EJ, Zeng Z, Borthakur G, Huang X, Kadia TM, Ruvolo PP, Feliu JB, Lu H, Debose L, Burger JA, Andreeff M, Liu W, Baggerly KA, Kornblau SM, Doyle LA, Estey EH, Kantarjian HM. Preclinical and early clinical evaluation of the oral AKT inhibitor, MK-2206, for the treatment of acute myelogenous leukemia. Clin Cancer Res. 2014 Apr 15;20(8):2226-35. doi: 10.1158/1078-0432.CCR-13-1978. Epub 2014 Feb 28. |
| Label | URL |
|---|---|
| UT MD Anderson Cancer Center Official Website | View source |
Not provided
Not provided
Recruitment Period: October 27, 2010 to October 30, 2012. All recruitment done in medical clinics, either UT MD Anderson Cancer Center or Fred Hutchinson Cancer Research Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Akt Inhibitor MK2206) | Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Baseline to 12 courses |
| Seattle |
| Washington |
| 98109 |
| United States |
| Fred Hutchinson Cancer Research Center Official Website | View source |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Akt Inhibitor MK2206) | Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Response of CR, CRp, or PR | Responses defined by International Working Group (IWG) 2003 Response Criteria: Morphologic Complete Response (CR): Peripheral blood counts: No circulating blasts, Neutrophil count >/= 1.0 x10^9/L, Platelet count >/= 100 x10^9/L; Bone marrow aspirate and biopsy: </= 5% blasts, No detectable Auer rods, No extramedullary leukemia. Partial Response (PR): No circulating blasts, Neutrophil count >/=1.0 x10^9/L, Platelet count >/= 100 x10^9/L, >/= 50 % reduction in bone marrow blast to 6% to 25%, or blasts \ | No participant was not evaluable for response. | Posted | Number | participants | 12 weeks of treatment |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Treatment-related Non-hematological Toxicity | Toxicity assessed using the NIH-NCI Common Terminology Criteria for Adverse Events, version 4.0 (CTCAEv4.0) | Posted | Count of Participants | Participants | Up to 30 days post-treatment |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Percentage Change in Apoptosis | Peripheral blood Acute Myeloid Leukemia (AML) cells (total 2 x 10^6) used to determine induction of apoptosis in AML stem cells by 4-color flow cytometry assay (CD34/CD38/CD123/annexin). Two-sample t-test conducted to compare changes between the responders and non-responders. Responders are participants who obtain a CR, CRp, or PR, with or without cytogenetic response. | The Assay did not work so no comparison can be made. | Posted | Baseline to 12 courses |
|
|
Participants followed for up to a total of 12 cycles (up to 36 weeks), with serious adverse events captured from consent until 30 days after last dose of drug. Overall adverse events were collected from January 26, 2011 to October 22, 2012.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment (Akt Inhibitor MK2206) | Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle | 12 | 19 | 19 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorectal infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Infections | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Lung, Sepsis |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Lung infection | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment | Symptoms skin lesions |
|
| Neutrophil count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bilateral carck in lungs | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Reversible posterior leukoencephalopathy syndrome | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Mucor fungal infection | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Soft Tissue Infection (cellulitis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Bruising | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Chills | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Electrocardiogram QT corrected interval prolonged | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hidradenitis | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Epistaxis | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fever | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Flushing | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Gait disturbance | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Poor Appetitue, Gastrointestinal | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Throat Yeast infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pancytopenia | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Laryngitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Periorbital edema | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| acute renal insufficiency, elevated creatinine | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Petechiae | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Leukemia Cutis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sore throat | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marina Konopleva, MD, PHD / Professor | The University of Texas (UT) MD Anderson Cancer Center | CR_Study_Registration@mdanderson.org |
| ID | Term |
|---|---|
| D007947 | Leukemia, Megakaryoblastic, Acute |
| D007948 | Leukemia, Monocytic, Acute |
| D015470 | Leukemia, Myeloid, Acute |
| D000013 | Congenital Abnormalities |
| D015479 | Leukemia, Myelomonocytic, Acute |
| D004915 | Leukemia, Erythroblastic, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C548887 | MK 2206 |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Title | Measurements |
|---|
|
|