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Phase 2
18 Years
Not Enrolling
Recurrent Adenoid Cystic Carcinoma of the Oral Cavity, Recurrent Salivary Gland Cancer, Salivary Gland Adenoid Cystic Carcinoma, Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity, Stage IVA Salivary Gland Cancer, Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity, Stage IVB Salivary Gland Cancer, Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity

Thank you

Trial Information



I. To determine the confirmed response rate in patients with progressive,
recurrent/metastatic adenoid cyst carcinoma (ACC) treated with Akt inhibitor MK2206


I. To evaluate the progression-free survival (PFS), overall survival (OS), and
safety/tolerability for MK-2206 in these patients.

ii. To explore potential genetic/cytogenetic/histopathologic predictors of clinical outcome
(i.e., response, PFS, OS) to MK-2206. (Exploratory) III. To explore the hypothesis that
MK-2206-mediated Akt inhibition and downregulation of c-myb protein levels in ACC tumors
correlates to clinical outcome (i.e., response, PFS, OS). (Exploratory)

OUTLINE: This is a multicenter study.

Patients receive Akt inhibitor MK2206 once weekly for 4 weeks. Courses repeat every 28 days
in the absence of disease progression or unacceptable toxicity. Patients may undergo tumor
tissue biopsies for correlative studies. Archived tumor tissue samples may be also

After completion of treatment, patients are followed up for up to 3 years.

Inclusion Criteria:

- Patients must have pathologically confirmed adenoid cystic carcinoma; confirmation
will be performed locally at each participating institution; cancers arising from
non-salivary gland primary sites are allowed

- (Salivary Gland Cancer [10039397] and Solid Tumor NOS [10029000])

- Patients must have measurable disease, as at least one lesion that can be accurately
measured in at least one dimension (longest diameter to be recorded for non-nodal
lesions and short axis for nodal lesions) as ≥ 2.0 cm with conventional techniques or
as ≥ 1.0 cm with spiral computed tomography (CT) scan; to be considered
pathologically enlarged and measurable, a lymph node must be > 1.5 cm in short axis
when assessed by CT scan (CT scan slice-thickness recommended to be no greater than 5

- Patients must have locally advanced and/or recurrent and/or metastatic disease not
amenable to potentially curative surgery or radiotherapy

- Patients must have increasing disease, defined as the presence of new or progressive
lesion(s) on CT/magnetic resonance imaging (MRI) within 6 months prior to study
enrollment and/or new/worsening disease-related symptoms; NOTE: This increase in
disease is to be determined in the oncologists best judgment and does not have to
meet RECIST criteria

- No patients with known brain metastases

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (equivalent to
Karnofsky ≥ 50%)

- Leukocytes ≥ 3,000/mm³

- Absolute neutrophil count ≥ 1,000/mm³

- Platelets ≥ 75,000/mm³

- Total bilirubin ≤ institutional upper limit of normal (ULN)

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or
serum glutamic pyruvate transaminase(SGPT) (alanine aminotransferase [ALT]) ≤ 2.5
institutional upper limit of normal

- Creatinine ≤ ULN OR creatinine clearance ≥ 60 mL/min

- Patients must be able to swallow whole tablets; NOTE: nasogastric or gastric (G) tube
administration is not allowed; tablets must not be crushed or chewed

- Patients must have the ability to understand and the willingness to sign a written
informed consent document

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to MK-2206 or other agents used in the study

- No diabetic patients with HbA1c levels of greater than 8%; patients with diabetes or
at risk for hyperglycemia should not be excluded from trials with MK-2206, but the
hyperglycemia should be well controlled before the patient enters the trial

- Cardiovascular baseline QTcF > 450 msec (male) or QTcF> 470 msec (female) will
exclude patients from entry on study

- No 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, in the opinion of the
investigator, would limit compliance with study requirements

- No pregnant women; women of child-bearing potential must have a negative serum or
urine pregnancy test within 7 days prior to registration

- Women of child-bearing potential and men must agree to use adequate
contraception (hormonal or barrier method of birth control; abstinence) prior to
study entry and for the duration of study participation

- No breastfeeding

- No human immunodeficiency virus (HIV)-positive patients on combination antiretroviral

- No other active malignancy, other than indolent malignancies which the investigator
determines are unlikely to interfere with treatment and safety analysis

- Chemotherapy and radiation therapy must be completed at least 4 weeks prior to

- If the last regimen included carmustine (BCNU) or mitomycin C, it must be
completed at least6 weeks prior to registration

- Any number of prior chemotherapy regimens is allowed, including no prior

- No patients who have received prior treatment with PI3K, Akt, or mTOR inhibitors for
recurrent/metastatic ACC

- No patients who are receiving any other investigational agents

- No patients receiving any medications or substances that are major inhibitors or
inducers of CYP450 3A4

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate (complete or partial response) according to Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Up to 32 weeks

Safety Issue:


Principal Investigator

Alan Thorson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B


United States: Food and Drug Administration

Study ID:




Start Date:

August 2012

Completion Date:

Related Keywords:

  • Recurrent Adenoid Cystic Carcinoma of the Oral Cavity
  • Recurrent Salivary Gland Cancer
  • Salivary Gland Adenoid Cystic Carcinoma
  • Stage IVA Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IVA Salivary Gland Cancer
  • Stage IVB Adenoid Cystic Carcinoma of the Oral Cavity
  • Stage IVB Salivary Gland Cancer
  • Stage IVC Adenoid Cystic Carcinoma of the Oral Cavity
  • Carcinoma
  • Carcinoma, Adenoid Cystic
  • Salivary Gland Neoplasms



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