Akt Inhibitor MK2206 in Treating Patients With Advanced Gastric or Gastroesophageal Junction Cancer

Titre officiel

A Phase II Study of MK-2206 (NSC-749607) as Second Line Therapy for Advanced Gastric and Gastroesophageal Junction Cancer

Sommaire:

JUSTIFICATION : Le MK2206 pourrait stopper la multiplication des cellules tumorales en inhibant certaines des enzymes nécessaires à leur croissance. OBJET : Cette étude clinique de phase II vise à déterminer l’efficacité du MK2206 dans le traitement des patients atteints d’un cancer de l’estomac ou de la jonction œso-gastrique avancé.

Description de l'essai

Primary Outcome:

• Overall survival of patients treated with Akt inhibitor MK2206

Secondary Outcome:

• Progression-free survival of patients treated with Akt inhibitor MK2206
• Response rate (confirmed and unconfirmed complete and partial response) according to RECIST 1.1
• Frequency and severity of toxicity incidents assessed by Common Terminology Criteria for Adverse Events version 4.0

PRIMARY OBJECTIVES:
I. To estimate the overall survival (OS) for patients with advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma treated with MK-2206. 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 Tumours [RECIST] 1.1) in this patient population. III. To assess the frequency and severity of toxicity associated with this regimen. OUTLINE:

This is a multicentre 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.

Voir cet essai sur ClinicalTrials.gov