Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer
This phase II clinical trial is studying how well Akt inhibitor MK2206 works in treating patients with advanced gastric or gastroesophageal junction cancer. Akt Inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Adenocarcinoma of the Gastroesophageal Junction
Adenocarcinoma of the Stomach
Recurrent Esophageal Cancer
Recurrent Gastric Cancer
Drug: Akt inhibitor MK2206
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer|
- Overall survival of patients treated with Akt inhibitor MK2206 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Progression-free survival of patients treated with Akt inhibitor MK2206 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Response rate (confirmed and unconfirmed complete and partial response) according to RECIST 1.1 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
- Frequency and severity of toxicity incidents assessed by Common Terminology Criteria for Adverse Events version 4.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2011|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Experimental: Treatment (Akt inhibitor MK2206)
Patients receive Akt inhibitor MK2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Drug: Akt inhibitor MK2206
Other Name: MK2206
I. To estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206.
I. To estimate the progression free survival (PFS) in this patient population. II. To estimate the response rate (confirmed and unconfirmed complete response [CR] and partial response [PR] by Response Evaluation Criteria In Solid Tumors [RECIST] 1.1) in this patient population.
III. To assess the frequency and severity of toxicity associated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive Akt inhibitor MK2206 orally (PO) once daily (QD), every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years.