## Protocol Section
### Identification Module
**NCT ID:** NCT01425879

**Brief Title:** MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery

**Official Title:** A Multi-Institutional Phase II Study of the Akt Inhibitor MK-2206 in Refractory Biliary Cancers

#### Organization Study ID Info
**ID:** NCI-2011-02974
#### Organization
**Class:** NIH
**Full Name:** National Cancer Institute (NCI)
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2011-02974
**Type:** REGISTRY
**ID:** OSU-10104
**ID:** OSU 10104
**ID:** CDR0000698451
**Domain:** Ohio State University Comprehensive Cancer Center
**ID:** OSU 10104
**Type:** OTHER
**Domain:** CTEP
**ID:** 8735
**Type:** OTHER
**ID:** N01CM00070
**Link:** https://reporter.nih.gov/quickSearch/N01CM00070
**Type:** NIH
**ID:** P30CA016058
**Link:** https://reporter.nih.gov/quickSearch/P30CA016058
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2014-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2016-06-17

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-05-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-05

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2016-04-15

**Type:** ESTIMATED

**Results First Submit Date:** 2016-03-15

**Results First Submit QC Date:** 2016-03-15

#### Start Date
**Date:** 2011-04

**Status Verified Date:** 2016-05

#### Study First Post Date
**Date:** 2011-08-30
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-27
**Study First Submit QC Date:** 2011-08-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** This phase II trial is studying how well MD2206 works in treating patients with advanced refractory biliary cancer that cannot be removed by surgery.

**Detailed Description:** PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (complete and partial response), as defined by the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, in patients with advanced refractory biliary cancers (BC) receiving Akt inhibitor MK2206 (MK2206).

SECONDARY OBJECTIVES:

I. To determine the frequency and severity of adverse events and tolerability of the regimen in patients with advanced refractory BC receiving MK2206.

II. To determine the overall and progression-free survival of patients with advanced refractory BC receiving MK2206.

III. To determine the presence of genetic mutations of PI3-kinase/ Akt pathway signaling-pathway genes relevant to BC and how these correlate with objective response to treatment with MK2206.

IV. To determine the pharmacokinetic and pharmacogenetic profile as a way of assessing inter-individual variability as well as how these relate to clinical outcomes.

V. To determine genetic variants and mutations in genes encoding drug-metabolizing enzymes and transporters, and genes involved in tumor biology, and how these may be related to response to treatment.

OUTLINE: This is a multicenter study.

Patients receive Akt inhibitor MK2206 orally (PO) on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline and periodically during study for pharmacokinetic, pharmacogenetic, and other correlative studies. Previously collected tumor tissue is also analyzed.

After completion of study therapy, patients are followed up for 4 weeks.

### Conditions Module

**Conditions:**

- 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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 8

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

**Intervention Names:**

- Drug: Akt Inhibitor MK2206

- Other: Diagnostic Laboratory Biomarker Analysis

- Other: Pharmacological Study

**Label:** Treatment (Akt inhibitor MK2206)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Treatment (Akt inhibitor MK2206)

**Description:** Given PO

**Name:** Akt Inhibitor MK2206

**Other Names:**

- MK2206

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Treatment (Akt inhibitor MK2206)

**Description:** Correlative studies

**Name:** Diagnostic Laboratory Biomarker Analysis

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Treatment (Akt inhibitor MK2206)

**Description:** Correlative studies

**Name:** Pharmacological Study

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

**Measure:** Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1

**Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year

#### Secondary Outcomes

**Description:** Severity of adverse events is graded according to the NCI CTCAE 4.0.

**Measure:** Frequency of Adverse Events Related to MK-2206

**Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year

**Description:** Analyzed using Kaplan-Meier method.

**Measure:** Overall Survival

**Time Frame:** From study initiation to time of death, assessed up to 4 weeks after completion of study treatment

**Description:** Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

**Measure:** Progression-free Survival

**Time Frame:** From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients must have histologically confirmed biliary tract carcinoma that is surgically unresectable

  * Cytological confirmation is not allowed on this study, as tissue is needed for correlative science analysis
  * Either fresh-frozen tissue (FFT) or paraffin-embedded tissue blocks (PETB) will be required from patients before enrolling on this study
  * No biopsies will be required unless there is insufficient tissue or if the PETB available is more than 12 months old
* Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 10 mm with spiral CT scan (CT scan slice thickness no greater than 5 mm)

  * Malignant lymph nodes will be considered measurable if they are ≥ 15 mm in short axis
* Patients must have received one prior therapy for metastatic disease

  * No prior Akt inhibitors allowed
* Patients with known brain metastases should be excluded from this clinical trial
* Life expectancy greater than 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\<2 (Karnofsky \>= 60%)
* Leukocytes \>= 3,000/mcL
* Absolute neutrophil count (ANC) \>= 1,500/mcL
* Platelet count \>= 100,000/mcL
* Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\] =\< 2.5 x IULN
* Creatinine within normal institutional limits OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (measured or calculated using the Cockroft-Gualt formula)
* Women of childbearing potential and men must use two forms of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
* Not pregnant or nursing
* Able to swallow oral tablets
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to Akt Inhibitor MK2206 (MK2206) or other agents used in the study
* Patients with diabetes or in risk for hyperglycemia should not be excluded from trials with MK2206, but the hyperglycemia should be well controlled on oral agents before the patient enters the trial
* Cardiovascular: baseline QTcF \> 450 msec (male) or QTcF \> 470 msec (female) will exclude patients from entry on study
* Patients with clinically significant bundle branch block or pre-existing clinically significant bradycardia will be excluded from the study
* No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; or psychiatric illness/social situations that would limit compliance with study requirements
* No concurrent grapefruit or grapefruit juice
* For patients having prior cryotherapy, radiofrequency ablation, ethanol injection, transarterial chemoembolization (TACE), or photodynamic therapy, the following criteria must be met:

  * 6 weeks has elapsed since that therapy
  * Indicator lesion(s) is/are outside the area of prior treatment or, if the only indicator lesion is inside the prior treatment area, there must be clear evidence of disease progression associated with that lesion
  * Edges of the indicator lesion are clearly distinct on CT scanning
  * Prior radiation therapy with or without the use of a fluoropyrimidine as a radiosensitizer in the adjuvant setting will be allowed on study if \> 12 weeks have elapsed since therapy
  * Prior palliative radiation therapy will allowed as long as \> 4 weeks have elapsed since therapy
* No patients who have had chemotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
* Patients may not be receiving any other investigational agents
* Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible
* Patients receiving any medications or substances that are inhibitors or inducers of CYP 450 3A4 are ineligible

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Los Angeles

**Country:** United States

**Facility:** USC / Norris Comprehensive Cancer Center

**State:** California

**Zip:** 90033

**Location 2:**

**City:** Washington

**Country:** United States

**Facility:** MedStar Georgetown University Hospital

**State:** District of Columbia

**Zip:** 20007

**Location 3:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University/Winship Cancer Institute

**State:** Georgia

**Zip:** 30322

**Location 4:**

**City:** Chapel Hill

**Country:** United States

**Facility:** University of North Carolina at Chapel Hill

**State:** North Carolina

**Zip:** 27599

**Location 5:**

**City:** Cleveland

**Country:** United States

**Facility:** Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

**State:** Ohio

**Zip:** 44106

**Location 6:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

**State:** Ohio

**Zip:** 44195

**Location 7:**

**City:** Columbus

**Country:** United States

**Facility:** Ohio State University Comprehensive Cancer Center

**State:** Ohio

**Zip:** 43210

**Location 8:**

**City:** Houston

**Country:** United States

**Facility:** M D Anderson Cancer Center

**State:** Texas

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** Ohio State University Comprehensive Cancer Center

**Name:** Tanios Bekaii-Saab

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000008107

- Term: Liver Diseases

- ID: D000001661

- Term: Biliary Tract Neoplasms

- ID: D000001660

- Term: Biliary Tract Diseases

- ID: D000005705

- Term: Gallbladder Diseases

- ID: D000001649

- Term: Bile Duct Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: HIGH

- As Found: Carcinoma

- ID: M25356

- Name: Carcinoma, Ductal

- Relevance: LOW

- As Found: Unknown

- ID: M9613

- Name: Carcinoma, Hepatocellular

- Relevance: HIGH

- As Found: Liver Carcinoma

- ID: M14850

- Name: Recurrence

- Relevance: HIGH

- As Found: Recurrent

- ID: M20426

- Name: Cholangiocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M8824

- Name: Gallbladder Neoplasms

- Relevance: HIGH

- As Found: Gallbladder Carcinoma

- ID: M4936

- Name: Bile Duct Neoplasms

- Relevance: HIGH

- As Found: Bile Duct Cancer

- ID: M11113

- Name: Liver Neoplasms

- Relevance: HIGH

- As Found: Adult Liver Carcinoma

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4947

- Name: Biliary Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M4946

- Name: Biliary Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8823

- Name: Gallbladder Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4935

- Name: Bile Duct Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T761

- Name: Biliary Tract Cancer

- Relevance: HIGH

- As Found: Biliary Cancer

- ID: T2425

- Name: Gallbladder Cancer

- Relevance: HIGH

- As Found: Gallbladder Carcinoma

- ID: T755

- Name: Bile Duct Cancer

- Relevance: HIGH

- As Found: Bile Duct Cancer

### Condition Browse Module - Meshes

- ID: D000002277

- Term: Carcinoma

- ID: D000006528

- Term: Carcinoma, Hepatocellular

- ID: D000005706

- Term: Gallbladder Neoplasms

- ID: D000001650

- Term: Bile Duct Neoplasms

- ID: D000008113

- Term: Liver Neoplasms

- ID: D000012008

- Term: Recurrence

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.

#### Event Groups

**Group ID:** EG000

**Title:** Treatment (Akt Inhibitor MK2206)

**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Diagnostic Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

**ID:** EG000

**Other Num Affected:** 8

**Other Num at Risk:** 8

**Serious Number At Risk:** 8

**Title:** Treatment (Akt Inhibitor MK2206)

**Frequency Threshold:** 5

#### Other Events

**Term:** Anemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Thrombocytopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Dry Mouth

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Dry Skin

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Fever

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Hand Foot Syndrome

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Hypophosphatemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Leukopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** CTCAE version 4.0

**Term:** Lymphopenia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Macular Rash

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Mucositis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Vomiting

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE version 4.0

**Term:** Hyponatremia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** CTCAE version 4.0

**Time Frame:** All patients were evaluable for toxicity from the time of their first treatment with MK2206

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 8

**Units:** Participants

### Group

**ID:** BG000

**Title:** Treatment (Akt Inhibitor MK2206)

**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Diagnostic Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies

### Measure

#### Measurement

**Group ID:** BG000

**Lower Limit:** 40

**Upper Limit:** 83

**Value:** 58

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 7

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** Intrahepatic

#### Measurement

**Group ID:** BG000

**Value:** 0

**Class Title:** Gallbladder

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** Extrahepatic

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** PS 0

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** PS 1

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** FULL_RANGE
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** patients
### Measure 5
**Parameter Type:** NUMBER
**Title:** Disease site
**Unit of Measure:** patients
### Measure 6
**Description:** Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

PS 0 defined as Normal activity. Fully active, able to carry on all pre-disease performance without restriction.

PS 1 defined as Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light housework, office work).
**Parameter Type:** NUMBER
**Title:** ECOG Performance Status
**Unit of Measure:** patients
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Point of Contact
**Email:** tanios.bekaii-saab@osumc.edu
**Organization:** The Ohio State University
**Phone:** 614-293-9863
**Title:** Tanios Bekaii-Saab, MD
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 50
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2.2
- **Spread:** 
- **Upper Limit:** 6.7
- **Value:** 3.5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 0.5
- **Spread:** 
- **Upper Limit:** 5.6
- **Value:** 1.7
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year
**Title:** Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1
**Type:** PRIMARY
**Unit of Measure:** patients
##### Group
**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Diagnostic Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies
**ID:** OG000
**Title:** Treatment (Akt Inhibitor MK2206)
#### Outcome Measure 2
**Description:** Severity of adverse events is graded according to the NCI CTCAE 4.0.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Up to 4 weeks after completion of study treatment, for total treatment time of up to 1 year
**Title:** Frequency of Adverse Events Related to MK-2206
**Type:** SECONDARY
**Unit of Measure:** percentage of patients
##### Group
**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Diagnostic Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies
**ID:** OG000
**Title:** Treatment (Akt Inhibitor MK2206)
#### Outcome Measure 3
**Description:** Analyzed using Kaplan-Meier method.
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** From study initiation to time of death, assessed up to 4 weeks after completion of study treatment
**Title:** Overall Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Diagnostic Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies
**ID:** OG000
**Title:** Treatment (Akt Inhibitor MK2206)
#### Outcome Measure 4
**Description:** Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
**Dispersion Type:** 95% Confidence Interval
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** From start of treatment to time of documented progression or death whichever occurs first, assessed up to 4 weeks after completion of study treatment
**Title:** Progression-free Survival
**Type:** SECONDARY
**Unit of Measure:** months
##### Group
**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Diagnostic Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies
**ID:** OG000
**Title:** Treatment (Akt Inhibitor MK2206)
### Participant Flow Module
#### Group
**Description:** Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206: Given PO

Diagnostic Laboratory Biomarker Analysis: Correlative studies

Pharmacological Study: Correlative studies
**ID:** FG000
**Title:** Treatment (Akt Inhibitor MK2206)
#### Period
**Title:** Overall Study
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
**Recruitment Details:** Patients were enrolled between September 2012 and December 2013
**Has Results:** True