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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01260701
First received: December 14, 2010
Last updated: December 6, 2013
Last verified: December 2013

December 14, 2010
December 6, 2013
January 2011
May 2014   (final data collection date for primary outcome measure)
Overall survival of patients treated with Akt inhibitor MK2206 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Overall survival of patients treated with Akt inhibitor MK2206 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01260701 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression-free survival of patients treated with Akt inhibitor MK2206 [ Designated as safety issue: No ]
  • Response rate (complete or partial response) in patients treated with Akt inhibitor MK2206 according to RECIST [ Designated as safety issue: No ]
  • Toxicity of Akt inhibitor MK2206 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

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 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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adenocarcinoma of the Gastroesophageal Junction
  • Adenocarcinoma of the Stomach
  • Recurrent Esophageal Cancer
  • Recurrent Gastric Cancer
Drug: Akt inhibitor MK2206
Given PO
Other Name: MK2206
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.
Intervention: Drug: Akt inhibitor MK2206
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
64
Not Provided
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal (GE) junction

    • Disease that has progressed after first-line regimen or is recurrent within the past 6 months after adjuvant therapy
  • Measurable disease by computed tomography (CT) scans or magnetic resonance imaging (MRI) within the past 28 days
  • No known brain metastases
  • More than 3 weeks since prior chemotherapy or radiotherapy (6 weeks for nitrosoureas or mitomycin C)
  • No prior PI3, AKT, or Mtor inhibitor for any reason
  • Recovered to =< grade 1 toxicities from prior therapy
  • No concurrent or plan to receive any other investigational agents
  • Able to tolerate oral medications

    • No malabsorption or chronic diarrhea (>= grade 2)
    • No feeding tube
  • Hemoglobin >= 9 g/dL
  • Absolute neutrophil count (ANC) >= 1,500/mcL
  • Platelet count >= 100,000/mcL
  • Total bilirubin =< institutional upper limit of normal
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional upper limit of normal (IULN) (=< 5.0 times IULN for patients with liver metastases)
  • Serum creatinine =< IULN OR calculated creatinine clearance > 50 mL/min
  • International normalized ratio (INR) =< 1.2 (unless taking therapeutic warfarin)
  • Fasting blood sugar =< 150 mg/dL
  • Hemoglobin A1C < 7%
  • QTcF < 450 msec (male) or QTcF < 470 msec (female)
  • Zubrod performance status 0-1
  • None of the following:

    • History of congenital long QT syndrome
    • New York Heart Association (NYHA) class III or IV heart failure
    • History of myocardial infarction within the past 6 months
    • Uncontrolled dysrhythmia
    • Poorly controlled angina
    • Resting heart rate =< 50 bpm (bradycardia)
  • At least 2 weeks since prior and no concurrent drugs that are strong inducers or inhibitors of CYP3A4
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric illness and/or social situations that would limit compliance with study requirements
  • No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
  • Patient must not be pregnant or nursing because of the risk of fetal or infant harm; women/men of reproductive potential must have agreed to use two forms of contraception for the duration of protocol treatment and for one month after discontinuation of MK-2206; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any time a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • More than 5 years since another malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or adequately treated stage I or II cancer for which the patient is currently in complete remission
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01260701
NCI-2011-02619, NCI-2011-02619, SWOG-S1005, CDR0000689602, S1005, S1005, U10CA032102
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Ramesh Ramanathan Southwest Oncology Group
National Cancer Institute (NCI)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP