Trial Outcomes & Findings for Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer (NCT NCT01186705)

Results Overview

in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

1 year

Results posted on

2015-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	MK-2206 This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens. MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical And Translational Study Of MK-2206 In Patients With Metastatic KRAS-Wild-Type, PIK3CA-Mutated, Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MK-2206 n=1 Participants This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens. MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

in patients with metastatic colorectal cancer with known PIK3CA mutations and wild type KRAS, to single agent MK-2206. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1)

Outcome measures

Outcome measures
Measure	MK-2206 n=1 Participants This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens. MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects.
Overall Objective Response Rate (ORR) Progression of Disease	1 participants
Overall Objective Response Rate (ORR) Stable Disease	0 participants

Adverse Events

MK-2206

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MK-2206 n=1 participants at risk This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens. MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1
Skin and subcutaneous tissue disorders Pruritus	100.0% 1/1 • Number of events 1
Metabolism and nutrition disorders Hypoalbuminemia	100.0% 1/1 • Number of events 1
Metabolism and nutrition disorders Hyperkalemia	100.0% 1/1 • Number of events 1
Blood and lymphatic system disorders White blood cell descreased	100.0% 1/1 • Number of events 1

Additional Information

Dr. Leonard Saltz

Memorial Sloan Kettering Cancer Center

Phone: 646-888-4286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place