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A PHASE II STUDY OF MK-2206 IN PATIENTS WITH PROGRESSIVE, RECURRENT/METASTATIC ADENOID CYSTIC CARCINOMA


Phase 2
18 Years
N/A
Not Enrolling
Both
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

A PHASE II STUDY OF MK-2206 IN PATIENTS WITH PROGRESSIVE, RECURRENT/METASTATIC ADENOID CYSTIC CARCINOMA


PRIMARY OBJECTIVES:

I. To determine the confirmed response rate in patients with progressive,
recurrent/metastatic adenoid cyst carcinoma (ACC) treated with Akt inhibitor MK2206
(MK-2206).

SECONDARY OBJECTIVES:

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
collected.

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
mm)

- 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
therapy

- 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
registration

- 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
treatment

- 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:

Interventional

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:

No

Principal Investigator

Alan Thorson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-01966

NCT ID:

NCT01604772

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

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021
Washington University School of Medicine Saint Louis, Missouri  63110
Fairview Ridges Hospital Burnsville, Minnesota  55337
Hutchinson Area Health Care Hutchinson, Minnesota  55350
United Hospital St. Paul, Minnesota  55102
Ridgeview Medical Center Waconia, Minnesota  55387
Carolinas Medical Center Charlotte, North Carolina  28232-2861
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Beebe Medical Center Lewes, Delaware  19958
Grandview Hospital Dayton, Ohio  45405
Mercy Hospital Coon Rapids, Minnesota  55433
Fairview-Southdale Hospital Edina, Minnesota  55435
Abbott-Northwestern Hospital Minneapolis, Minnesota  55407
Regions Hospital Saint Paul, Minnesota  55101
Saint Francis Regional Medical Center Shakopee, Minnesota  55379
Rice Memorial Hospital Willmar, Minnesota  56201
Miami Valley Hospital Dayton, Ohio  45409
Wayne Hospital Greenville, Ohio  45331
Greene Memorial Hospital Xenia, Ohio  45385
Union Hospital of Cecil County Elkton MD, Maryland  21921
Northwestern University Chicago, Illinois  60611
Hennepin County Medical Center Minneapolis, Minnesota  
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah  84112
Metro-Minnesota CCOP St. Louis Park, Minnesota  
Lakeview Hospital Stillwater, Minnesota  55082
University of Chicago Comprehensive Cancer Center Chicago, Illinois  60637-1470
Edna Williams Cancer Center at the Baptist Cancer Institute Jacksonville, Florida  32207
Reid Hospital and Health Care Services Richmond, Indiana  47374
Mercy Medical Center-Sioux City Sioux City, Iowa  51104
Saint Luke's Regional Medical Center Sioux City, Iowa  51104
Unity Hospital Fridley, Minnesota  55432
Saint John's Hospital - Healtheast Maplewood, Minnesota  55109
Minnesota Oncology Hematology PA-Maplewood Maplewood, Minnesota  55109
North Memorial Medical Health Center Robbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota  55416
Minnesota Oncology and Hematology PA-Woodbury Woodbury, Minnesota  55125
Cooper Hospital University Medical Center Camden, New Jersey  08103
Good Samaritan Hospital - Dayton Dayton, Ohio  45406
Dayton CCOP Dayton, Ohio  45429
Samaritan North Health Center Dayton, Ohio  45415
Blanchard Valley Hospital Findlay, Ohio  45840
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio  45005-1066
Kettering Medical Center Kettering, Ohio  45429
Upper Valley Medical Center Troy, Ohio  45373
Carolinas Medical Center - Northeast Concord, North Carolina  28025
Siouxland Hematology Oncology Associates Sioux City, Iowa  51101
Franciscan St. Francis Health Indianapolis, Indiana  46237
Christiana Care Health System-Christiana Hospital Newark, Delaware  19718
Carolinas Medical Center-Union Monroe, North Carolina  28112
Cleveland Regional Medical Center Shelby, North Carolina  28150