Know Cancer

or
forgot password


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

Thank you

Trial Information


Key

Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of any advanced/metastatic solid
tumor suitable for treatment with docetaxel.

- Tumor recurred or progressed following at least one line of chemotherapy, except if
no standard of care exists or if the patient refuses standard of care treatment.

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

- Must be able to take and retain oral medications.

- Other criteria exist.

Key Exclusion Criteria:

- Active concomitant malignancies.

- Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and
is on steroids, the steroid dose must be stable for at least 30 days prior to study
start).

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

- Requiring intravenous (IV) alimentation.

- Pregnancy or lactation.

- Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21
days prior to first dose of study drug.

- Anti-ErbB1 and/or ErbB2 targeted therapy or anticancer hormonal therapy within 14
days prior to first dose of study drug.

- History of hypersensitivity to or intolerance of docetaxel.

- Other 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 study drug in combination with docetaxel.

Outcome Time Frame:

Duration of study

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

ARRAY-543-104

NCT ID:

NCT00833326

Start Date:

January 2009

Completion Date:

July 2010

Related Keywords:

  • Advanced Cancer
  • Neoplasms

Name

Location

University of Colorado Health Sciences CenterDenver, Colorado  80262
Sarah Cannon Research InstituteNashville, Tennessee  37203
Mayo Cancer CenterRochester, Minnesota  55905