Trial Outcomes & Findings for MK2206 in Treating Patients With Advanced Liver Cancer That Did Not Respond to Previous Therapy (NCT NCT01239355)

Last Updated: 2015-10-05

Results Overview

Estimated using the product-limit method of Kaplan and Meier. 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 (the sum must also demonstrate an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Until disease progression or death, up to 26 months

Results posted on

2015-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Akt Inhibitor MK2206) Patients receive 200mg oral Akt inhibitor MK2206 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 Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MK2206 in Treating Patients With Advanced Liver Cancer That Did Not Respond to Previous Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Akt Inhibitor MK2206) n=15 Participants Patients receive 200mg oral Akt inhibitor MK2206 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 Laboratory Biomarker Analysis: Correlative studies
Age, Continuous	65 years n=93 Participants
Sex: Female, Male Female	3 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Region of Enrollment United States	15 participants n=93 Participants

PRIMARY outcome

Timeframe: Until disease progression or death, up to 26 months

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=15 Participants Patients receive 200mg oral Akt inhibitor MK2206 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 Laboratory Biomarker Analysis: Correlative studies
Progression-free Survival	1.7 Months Interval 1.6 to 3.0

SECONDARY outcome

Timeframe: Evaluated for response every 2 cycles (8 weeks) with confirmatory evaluation at least 4 weeks following initial documentation of objective response, up to 26 months

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; Objective Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=15 Participants Patients receive 200mg oral Akt inhibitor MK2206 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 Laboratory Biomarker Analysis: Correlative studies
Objective Response	0 participants

SECONDARY outcome

Timeframe: Until death, up to 26 months

Survival will be estimated by the product-limit (Kaplan-Meier) estimator.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=15 Participants Patients receive 200mg oral Akt inhibitor MK2206 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 Laboratory Biomarker Analysis: Correlative studies
Overall Survival	6.1 Months Interval 3.0 to 8.4

Adverse Events

Treatment (Akt Inhibitor MK2206)

Serious events: 6 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Akt Inhibitor MK2206) n=15 participants at risk Patients receive 200mg oral Akt inhibitor MK2206 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 Laboratory Biomarker Analysis: Correlative studies
Gastrointestinal disorders Ascites	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Oral pain	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	13.3% 2/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	13.3% 2/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Bone pain	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Movements involuntary	6.7% 1/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Other adverse events

Other adverse events
Measure	Treatment (Akt Inhibitor MK2206) n=15 participants at risk Patients receive 200mg oral Akt inhibitor MK2206 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 Laboratory Biomarker Analysis: Correlative studies
Blood and lymphatic system disorders Anemia	73.3% 11/15 • Number of events 17 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Cardiac disorders Sinus tachycardia	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal distension	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Abdominal pain	6.7% 1/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Bloating	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Constipation	26.7% 4/15 • Number of events 6 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Diarrhea	40.0% 6/15 • Number of events 6 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Dry mouth	33.3% 5/15 • Number of events 6 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Gastrointestinal pain	6.7% 1/15 • Number of events 3 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Mucositis oral	20.0% 3/15 • Number of events 3 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Nausea	20.0% 3/15 • Number of events 4 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Rectal hemorrhage	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Stomach pain	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Toothache	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Gastrointestinal disorders Vomiting	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Chills	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema limbs	13.3% 2/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Edema trunk	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fatigue	60.0% 9/15 • Number of events 14 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Fever	13.3% 2/15 • Number of events 3 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Flu like symptoms	13.3% 2/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
General disorders Pain	13.3% 2/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Infections and infestations Mucosal infection	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Activated partial thromboplastin time pr	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alanine aminotransferase increased	46.7% 7/15 • Number of events 14 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Alkaline phosphatase increased	53.3% 8/15 • Number of events 21 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Aspartate aminotransferase increased	73.3% 11/15 • Number of events 26 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Blood bilirubin increased	20.0% 3/15 • Number of events 11 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Creatinine increased	20.0% 3/15 • Number of events 3 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Electrocardiogram QT corrected interval	20.0% 3/15 • Number of events 6 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations INR increased	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Lymphocyte count decreased	20.0% 3/15 • Number of events 7 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Neutrophil count decreased	26.7% 4/15 • Number of events 6 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Platelet count decreased	40.0% 6/15 • Number of events 17 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations Weight gain	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Investigations White blood cell decreased	20.0% 3/15 • Number of events 11 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Anorexia	26.7% 4/15 • Number of events 5 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypercalcemia	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperglycemia	60.0% 9/15 • Number of events 19 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyperkalemia	13.3% 2/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypoalbuminemia	46.7% 7/15 • Number of events 10 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypokalemia	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hyponatremia	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Metabolism and nutrition disorders Hypophosphatemia	20.0% 3/15 • Number of events 4 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Back pain	6.7% 1/15 • Number of events 4 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Flank pain	6.7% 1/15 • Number of events 4 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Dysgeusia	6.7% 1/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Headache	13.3% 2/15 • Number of events 4 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Presyncope	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Nervous system disorders Somnolence	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Depression	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Psychiatric disorders Insomnia	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urinary tract obstruction	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Renal and urinary disorders Urine discoloration	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	6.7% 1/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Cough	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.3% 2/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	6.7% 1/15 • Number of events 2 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Alopecia	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Dry skin	20.0% 3/15 • Number of events 3 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Periorbital edema	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Pruritus	26.7% 4/15 • Number of events 11 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 5/15 • Number of events 12 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.
Vascular disorders Hypertension	6.7% 1/15 • Number of events 1 • Adverse events recorded over a period of 1 year and 5 months. "Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Additional Information

DCC Project Administrator

California Cancer Consortium

Phone: 626-256-4673

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60