Trial Outcomes & Findings for MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery (NCT NCT01425879)

Last Updated: 2016-06-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

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

Results posted on

2016-06-17

Participant Flow

Patients were enrolled between September 2012 and December 2013

Participant milestones

Participant milestones
Measure	Treatment (Akt Inhibitor MK2206) 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
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MK2206 in Treating Patients With Advanced Refractory Biliary Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Akt Inhibitor MK2206) n=8 Participants 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
Age, Continuous	58 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 patients n=5 Participants
Disease site Intrahepatic	6 patients n=5 Participants
Disease site Gallbladder	0 patients n=5 Participants
Disease site Extrahepatic	2 patients n=5 Participants
ECOG Performance Status PS 0	2 patients n=5 Participants
ECOG Performance Status PS 1	6 patients n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=8 Participants 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
Overall Response Rate (Complete and Partial Response) as Defined by RECIST 1.1	0 patients

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=8 Participants 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
Frequency of Adverse Events Related to MK-2206 lymphopenia	75 percentage of patients
Frequency of Adverse Events Related to MK-2206 rash	63 percentage of patients
Frequency of Adverse Events Related to MK-2206 fatigue	50 percentage of patients
Frequency of Adverse Events Related to MK-2206 fever	50 percentage of patients
Frequency of Adverse Events Related to MK-2206 vomiting	50 percentage of patients
Frequency of Adverse Events Related to MK-2206 diarrhea	50 percentage of patients

SECONDARY outcome

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

Analyzed using Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=8 Participants 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
Overall Survival	3.5 months Interval 2.2 to 6.7

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=8 Participants 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
Progression-free Survival	1.7 months Interval 0.5 to 5.6

Adverse Events

Treatment (Akt Inhibitor MK2206)

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Akt Inhibitor MK2206) n=8 participants at risk 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
Blood and lymphatic system disorders Anemia	12.5% 1/8 • Number of events 1 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Gastrointestinal disorders Constipation	12.5% 1/8 • Number of events 1 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Blood and lymphatic system disorders Thrombocytopenia	25.0% 2/8 • Number of events 2 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Gastrointestinal disorders Diarrhea	50.0% 4/8 • Number of events 4 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Gastrointestinal disorders Dry Mouth	25.0% 2/8 • Number of events 2 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Skin and subcutaneous tissue disorders Dry Skin	37.5% 3/8 • Number of events 3 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
General disorders Fatigue	50.0% 4/8 • Number of events 4 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Blood and lymphatic system disorders Fever	50.0% 4/8 • Number of events 4 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Skin and subcutaneous tissue disorders Hand Foot Syndrome	37.5% 3/8 • Number of events 3 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Metabolism and nutrition disorders Hypophosphatemia	25.0% 2/8 • Number of events 2 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Investigations Leukopenia	12.5% 1/8 • Number of events 1 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Blood and lymphatic system disorders Lymphopenia	75.0% 6/8 • Number of events 6 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Skin and subcutaneous tissue disorders Macular Rash	62.5% 5/8 • Number of events 5 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Gastrointestinal disorders Mucositis	37.5% 3/8 • Number of events 3 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Gastrointestinal disorders Nausea	37.5% 3/8 • Number of events 3 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Gastrointestinal disorders Vomiting	50.0% 4/8 • Number of events 4 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.
Metabolism and nutrition disorders Hyponatremia	12.5% 1/8 • Number of events 1 • All patients were evaluable for toxicity from the time of their first treatment with MK2206 NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 was utilized for Adverse Event reporting.

Additional Information

Tanios Bekaii-Saab, MD

The Ohio State University

Phone: 614-293-9863

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60