Trials / Completed
CompletedNCT01260701
Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer
A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II clinical trial studies 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.
Detailed description
PRIMARY OBJECTIVES: I. To estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206 (Akt inhibitor MK2206). SECONDARY OBJECTIVES: 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 (CLOSED TO ACCRUAL 05/01/13): Patients receive Akt inhibitor MK2206 orally (PO) every other day on days 1-28. 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.
Conditions
- Adenocarcinoma of the Gastroesophageal Junction
- Diffuse Gastric Adenocarcinoma
- Gastric Intestinal Type Adenocarcinoma
- Gastric Mixed Adenocarcinoma
- Recurrent Gastric Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Akt Inhibitor MK2206 | Given PO |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2014-05-01
- Completion
- 2015-07-01
- First posted
- 2010-12-15
- Last updated
- 2016-01-18
- Results posted
- 2014-08-04
Locations
187 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT01260701. Inclusion in this directory is not an endorsement.