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



Status:Completed
Conditions:Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:January 2011
End Date:July 2015

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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 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.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed adenocarcinoma of the
stomach or gastroesophageal (GE) junction that has progressed after first-line
treatment, or is recurrent within 6 months after receiving adjuvant therapy; patients
must have had exactly one prior systemic treatment regimen; previous adjuvant
(chemotherapy [chemo]) radiotherapy is permitted; prior chemotherapy given
concurrently with radiation for radiosensitization is not considered one prior
systemic regimen

- Patients must have measurable disease; computed tomography (CT) scans or magnetic
resonance imaging (MRIs) used to assess measurable disease must have been completed
within 28 days prior to registration; CT scans or MRIs used to assess non-measurable
disease must have been completed within 42 days prior to registration; all disease
must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1)

- Patients must not have known brain metastases

- Patients must not have received chemotherapy or radiotherapy within 3 weeks (6 weeks
for nitrosoureas or mitomycin C) prior to registration

- Patient must not have received prior treatment with a phosphatidylinositol 3 (PI3),
v-akt murine thymoma viral oncogene homolog 1 (AKT) or mechanistic target of
rapamycin (Mtor) inhibitor for any reason

- All toxicities from prior therapy must have resolved to =< grade 1 (Common
Terminology Criteria for Adverse Events [CTCAE] version 4.0) prior to registration

- Patients must not be receiving or planning to receive any other investigational
agents

- Patients must be able to tolerate oral medications and must not have malabsorption or
chronic diarrhea (CTCAE version 4.0 grade 2 or higher); administration through a
feeding tube is not permitted

- Hemoglobin >= 9 g/dL

- Absolute neutrophil count (ANC) >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< institutional upper limit of normal (IULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 2.5 x
IULN; patients with liver metastases must have AST and ALT =< 5 x IULN

- Patients must have adequate kidney function as evidenced by at least ONE of the
following:

- Serum creatinine (mg/dL) =< IULN obtained within 14 days prior to registration

- Calculated creatinine clearance > 50 ml/min; the serum creatinine value used in
the calculation must have been obtained within 14 days prior to registration

- Patients must have international normalized ratio (INR) =< 1.2 unless taking
therapeutic doses of warfarin; this result must be obtained within 14 days prior to
registration

- Patients must have fasting blood sugar =< 150 mg/dL within 28 days prior to
registration

- Patients must have hemoglobin A1C < 7% within 28 days prior to registration

- Patients must have an electrocardiogram (ECG) within 28 days prior to registration;
patients must have corrected QT interval (QTcF) (by Fridericia's calculation) < 450
msec (male) or < 470 msec (female)

- Patients must have a Zubrod performance status of 0-1

- Patient must not have any of the following: a history of congenital long QT syndrome;
use of concomitant medications that could prolong the QTc interval; New York Heart
Association class III or IV heart failure; history of myocardial infarction within 6
months prior to registration; uncontrolled dysrhythmias; poorly controlled angina;
resting heart rate =< 50 bpm (bradycardia)

- Patients must not be receiving concurrent treatment with drugs that are strong
inducers or inhibitors of cytochrome P450 family 3, subfamily A, polypeptide 4
(CYP3A4); patients must be able to safely discontinue treatment with these agents for
>= 2 weeks prior to beginning protocol therapy

- Patient must not have uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements

- Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral
therapy are ineligible

- Patient must not be pregnant or nursing; 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

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease free for five years

- 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
We found this trial at
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929 N St Francis St
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1200 Moursund Street
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3181 Southwest Sam Jackson Park Road
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60 Crittenden Blvd # 70
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