Trial Outcomes & Findings for Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer (NCT NCT01307631)

Last Updated: 2022-02-11

Results Overview

Activity will be ascertained by the proportion of patients who survive progression-free for at least 6 months after initiating therapy or who have objective tumor response. 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. Any pathological lymph node must have reduction in short axis to \< 10 mm; Partial Response (PR), at least 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

37 participants

Primary outcome timeframe

Up to 6 months

Results posted on

2022-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Akt Inhibitor MK2206) PIK3CA Mutation Patients with PIK3CA mutation receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies	Treatment (Akt Inhibitor MK2206) Wild Type Patients with wild type receive Akt inhibitor MK2206 PO once weekly. 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	9	28
Overall Study COMPLETED	9	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Akt Inhibitor MK2206 in Treating Patients With Recurrent or Advanced Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Akt Inhibitor MK2206 n=37 Participants Patients receive Akt inhibitor MK2206 PO once weekly. 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, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Number of patients who had an objective response.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206 n=37 Participants Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies	Treatment (Akt Inhibitor MK2206) Wild Type Patients with wild type receive Akt inhibitor MK2206 PO once weekly. 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 Tumor Response According to RECIST	2 Participants	—

PRIMARY outcome

Timeframe: From start of treatment to time of objective disease progression, assessed up to 6 months

Population: Number of patients who had a PFS \> 6 months.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206 n=37 Participants Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies	Treatment (Akt Inhibitor MK2206) Wild Type Patients with wild type receive Akt inhibitor MK2206 PO once weekly. 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 According to RECIST	4 Participants	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: Overall survival of all patients on study.

Estimated by using Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206 n=37 Participants Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies	Treatment (Akt Inhibitor MK2206) Wild Type Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Duration of Overall Survival	8 months Interval 0.0 to 12.0	—

SECONDARY outcome

Timeframe: Up to 3 years

Estimated by using Kaplan-Meier analysis.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206 n=9 Participants Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies	Treatment (Akt Inhibitor MK2206) Wild Type n=28 Participants Patients with wild type receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Duration of Progression-free Survival	1.6 months Interval 0.0 to 1.6	1.8 months Interval 0.0 to 1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 years

Data is reported in the Adverse Event table.

Outcome measures

Outcome data not reported

Adverse Events

Treatment (Akt Inhibitor MK2206

Serious events: 14 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Akt Inhibitor MK2206 n=37 participants at risk Patients receive Akt inhibitor MK2206 PO once weekly. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Skin and subcutaneous tissue disorders Rash	18.9% 7/37 • Number of events 7 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
General disorders Hyperglycemia	5.4% 2/37 • Number of events 2 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
General disorders Fever	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Blood and lymphatic system disorders Thromboembolic event	10.8% 4/37 • Number of events 4 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.

Other adverse events

Other adverse events
Measure	Treatment (Akt Inhibitor MK2206 n=37 participants at risk Patients receive Akt inhibitor MK2206 PO once weekly. 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 abdominal pain	10.8% 4/37 • Number of events 5 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Renal and urinary disorders Acute kdiney injury	5.4% 2/37 • Number of events 2 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
General disorders edema limbs	13.5% 5/37 • Number of events 5 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Metabolism and nutrition disorders anorexia	8.1% 3/37 • Number of events 3 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Investigations creatinine decreased	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Nervous system disorders peripheral sensory neuropathy	16.2% 6/37 • Number of events 6 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
General disorders fatigue	29.7% 11/37 • Number of events 13 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Gastrointestinal disorders constipation	13.5% 5/37 • Number of events 6 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Gastrointestinal disorders diarrhea	16.2% 6/37 • Number of events 8 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Infections and infestations urinary tract infections	5.4% 2/37 • Number of events 2 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Metabolism and nutrition disorders hyponatremia	2.7% 1/37 • Number of events 2 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Skin and subcutaneous tissue disorders skin ulceration	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Reproductive system and breast disorders pelvic pain	5.4% 2/37 • Number of events 2 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Reproductive system and breast disorders vaginal hemorrhage	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Gastrointestinal disorders nausea	13.5% 5/37 • Number of events 5 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Psychiatric disorders anxiety	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Metabolism and nutrition disorders hypomagnesemia	8.1% 3/37 • Number of events 3 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Psychiatric disorders insomnia	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Blood and lymphatic system disorders anemia	5.4% 2/37 • Number of events 5 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Musculoskeletal and connective tissue disorders arthralgia	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Musculoskeletal and connective tissue disorders back pain	8.1% 3/37 • Number of events 4 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Skin and subcutaneous tissue disorders nail discoloration	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Gastrointestinal disorders vomiting	8.1% 3/37 • Number of events 3 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Investigations weight loss	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Vascular disorders hot flashes	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Injury, poisoning and procedural complications bruising	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Metabolism and nutrition disorders hyperglycemia	10.8% 4/37 • Number of events 4 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Respiratory, thoracic and mediastinal disorders pleuritic pain	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
General disorders non-cardiac chest pain	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Respiratory, thoracic and mediastinal disorders cough	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Renal and urinary disorders urinary frequency	2.7% 1/37 • Number of events 2 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Renal and urinary disorders hematuria	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Investigations creatinine increased	2.7% 1/37 • Number of events 2 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Musculoskeletal and connective tissue disorders bone pain	5.4% 2/37 • Number of events 4 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.
Nervous system disorders ataxia	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the treatment start of the patient to 30 days after the patient has come off treatment.

Additional Information

Jennifer Curtis, MS

Dana-Farber Cancer Institute

Phone: 617-582-7183

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60