Trial Outcomes & Findings for A Phase II Study of Akt Inhibitor MK2206 in the Treatment of Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer (NCT NCT01283035)

Last Updated: 2016-06-24

Results Overview

If 4 or more of the final set of 29 patients demonstrate a response, then the null hypothesis H0: =\< 5% can be rejected in favor of the alternative hypothesis H1: \>= 20% with an alpha of 0.05 and beta of 0.20 (i.e., 80% power). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) 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; Progression, 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; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

6 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2016-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Akt Inhibitor MK2206) Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Akt Inhibitor MK2206) Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Overall Study Subject later found ineligible	1

Baseline Characteristics

A Phase II Study of Akt Inhibitor MK2206 in the Treatment of Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Akt Inhibitor MK2206) n=5 Participants Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug. 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	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: Five patients started study treatment.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=5 Participants Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Stable Disease	4 participants
Efficacy (as Measured by Objective Response Rate) of Akt Inhibitor MK2206 in Patients With Recurrent High-grade Platinum-resistant Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Progressive Disease	1 participants

SECONDARY outcome

Timeframe: Up to 3 years

Population: Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.

The frequency of mutations in the PI3K/AKT and RAS pathways, copy number alterations, and PTEN loss and AKT expression as assessed by IHC will be tabulated. Associations between these markers with clinical outcome such as response rate and duration of PFS will be assessed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.

Distributions will be estimated using Kaplan-Meier analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Minimal activity was observed and patient accrual was slow. This analysis was not completed as the data was not collected.

Distributions will be estimated using Kaplan-Meier analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Number of participants experiencing toxicities.

Outcome measures

Outcome measures
Measure	Treatment (Akt Inhibitor MK2206) n=5 Participants Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Toxicities of Akt Inhibitor MK2206, as Assessed by the Active Version of the NCI Common Terminology Criteria for Adverse Events (CTCAE v4.0)	5 participants

Adverse Events

Treatment (Akt Inhibitor MK2206)

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Akt Inhibitor MK2206) n=5 participants at risk Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Skin and subcutaneous tissue disorders Rash maculo-papular	80.0% 4/5 • Number of events 4 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Gastrointestinal disorders Colonic Obstruction	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.

Other adverse events

Other adverse events
Measure	Treatment (Akt Inhibitor MK2206) n=5 participants at risk Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug. Akt Inhibitor MK2206: Given PO Laboratory Biomarker Analysis: Correlative studies
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Metabolism and nutrition disorders Hyperglycemia	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Gastrointestinal disorders Abdominal Pain	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Gastrointestinal disorders Chelitis	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Eye disorders Conjunctivitis	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Gastrointestinal disorders Diarrhea	40.0% 2/5 • Number of events 2 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Nervous system disorders Dysgeusia	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
General disorders Fatigue	60.0% 3/5 • Number of events 3 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Investigations Increased urea	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Gastrointestinal disorders Oral mucositis	40.0% 2/5 • Number of events 2 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Skin and subcutaneous tissue disorders Pruritis	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Respiratory, thoracic and mediastinal disorders Throat tightening	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.
Respiratory, thoracic and mediastinal disorders Wheezing	20.0% 1/5 • Number of events 1 • Adverse event data was collected from the initiation of the study intervention, throughout the study, and within 30 days of the last study intervention.

Additional Information

Joyce Liu, MD, MPH

DFCI

Phone: 617-632-5269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60