Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Adenocarcinoma

Stomach Neoplasms

Recurrence

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Patients receive Akt inhibitor MK2206 PO every other day on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Akt Inhibitor MK2206

Ramesh Ramanathan

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.

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.

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

Overall survival is calculated from date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

PFS is measured from date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and without report of progression are censored at date of last contact. Progression is one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy), as well as an absolute increase of at least 0.5 cm; unequivocal progression of non-measurable disease in the opinion of the treating physician; appearance of any new lesion/site; death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.

Complete response (CR) is complete disappearance of all target and non-target lesions, no new lesions, and no disease related symptoms. Any lymph nodes must have reduction in short axis to \< 1.0 cm. Partial response (PR) is \>= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions, no unequivocal progression of non-measurable disease, and no new lesions. Confirmed CR is two or more statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Confirmed PR is two or more statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration, but not qualifying as CR. Unconfirmed CR is one status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.

Any CTCAE 4.0 event of Grade 3 (severe), Grade 4 (life threatening), or Grade 5 (fatal) which were possibly, probably or definitely related to protocol treatment are included.

National Cancer Institute (NCI)

Eligible patients who received any treatment and were assessed for adverse events are included in the adverse event summaries.

Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

MK-2206

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

White

Asian

Unknown

Race/Ethnicity, Customized

Eligible patients who began protocol therapy.

Study Statistician

Eligible patients who began protocol therapy

Progression Free Survival (PFS)

Overall Survival (OS)

Eligible patients who began protocol therapy and were assessed for response.

Response Rate (Complete and Partial, Confirmed and Unconfirmed)

Adult respiratory distress syndrome

Alanine aminotransferase increased

Alkaline phosphatase increased

Allergic reaction

Anemia

Anorexia

Aspartate aminotransferase increased

Blood and lymphatic system disorders - Other

Blood bilirubin increased

Cardiac arrest

Dehydration

Dyspnea

Fatigue

Gastric hemorrhage

Gastroesophageal reflux disease

Hyperglycemia

Hypokalemia

Hyponatremia

Hypoxia

Lung infection

Lymphocyte count decreased

Nausea

Non-cardiac chest pain

Pleural effusion

Pneumonitis

Pruritus

Rash acneiform

Rash maculo-papular

Respiratory failure

Sinus bradycardia

Sinus tachycardia

Stroke

Upper gastrointestinal hemorrhage

Vomiting

Eligible patients who received any treatment and were assessed for adverse events are included in this summary.

Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer	NCT01260701	Adenocarcinoma ... Diffuse Gastric... Gastric Intesti... Gastric Mixed A... Recurrent Gastr...	Akt Inhibitor M...	18 Years -	National Cancer Institute (NCI)
Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer	NCT01260701	Adenocarcinoma ... Diffuse Gastric... Gastric Intesti... Gastric Mixed A... Recurrent Gastr...	Akt Inhibitor M...	18 Years -	National Cancer Institute (NCI)

Spots Global Cancer Trial Database for diffuse gastric adenocarcinoma