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Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors, Advanced or Metastatic Biliary Cancer, Metastatic Colorectal Cancer

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Trial Information

Inclusion Criteria


Key Inclusion Criteria (for Part 3):

- A histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma
which is metastatic (measurable disease).

- Documented KRAS- or BRAF- tumor mutation.

- Previously treated with or unsuitable for treatment with 5-Fluorouracil (5-FU),
oxaliplatin, irinotecan and, if available, bevacizumab.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.

- Additional criteria exist.

Key Exclusion Criteria (for Part 3):

- Uncontrolled or symptomatic brain metastases (if the patient has brain metastases and
is on steroids, the steroid dose must have been stable for at least 30 days).

- History of central serous retinopathy, retinopathy visible at baseline that would be
considered a risk factor for central serous retinopathy or retinal vein occlusion.

- Concomitant malignancies or previous malignancies with less than a 2-year disease
free interval at the time of enrollment; patients with adequately resected basal or
squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or stage A low
grade prostate cancer may enroll irrespective of the time of diagnosis.

- Prior treatment with a MEK inhibitor.

- Treatment with prior chemotherapy, anticancer immunotherapy, monoclonal antibodies or
other protein or peptide therapeutics within 21 days of the first dose of study drug.

- Treatment with a small molecule targeted agent or anticancer hormonal therapy within
14 days of the first dose of study drug.

- Treatment with prior radiotherapy within 28 days of initiating study drug (if the
radiation portal covered ≤ 10% of the bone marrow reserve, the patient may be
enrolled irrespective of the end date of radiotherapy).

- Major surgery within 4 weeks or minor surgery within 7 days prior to the first dose
of study drug.

- Known positive serology for the human immunodeficiency virus (HIV), hepatitis C,
and/or active hepatitis B.

- Additional criteria exist.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Establish the maximum tolerated dose (MTD) of the study drug.

Outcome Time Frame:

Part 1, one year

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

ARRAY-162-111

NCT ID:

NCT00959127

Start Date:

August 2009

Completion Date:

January 2013

Related Keywords:

  • Advanced Solid Tumors
  • Advanced or Metastatic Biliary Cancer
  • Metastatic Colorectal Cancer
  • Colorectal Adenocarcinoma
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms
  • Biliary Tract Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Colorado Cancer CenterDenver, Colorado  80262
Washington University School of MedicineSaint Louis, Missouri  63110
Ohio State UniversityColumbus, Ohio  43210
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231
University of California, Los AngelesLos Angeles, California  
Dana-Farber/Harvard Cancer CenterBoston, Massachusetts  02115
Sarah Cannon Research InstituteNashville, Tennessee  37203
South Texas Accelerated Research TherapeuticsSan Antonio, Texas  78229