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

Thank you

Trial Information


Key

Inclusion Criteria:



- Histological or cytological evidence of malignancy.

- Patients with advanced solid tumors who are no longer candidates for standard
therapy, have no standard therapy available, or choose not to pursue standard
therapy.

- Cardiac ejection fraction ≥ 50% by echocardiogram (ECHO) or multiple gated
acquisition (MUGA).

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

- Additional criteria exist.

Key Exclusion Criteria:

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

- Use of an investigational medication or device within 30 days prior to first dose of
study drug.

- Major surgery within 30 days prior to first dose of study drug.

- Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not
including palliative radiotherapy at focal sites).

- Active, uncontrolled infection requiring systemic antibiotic therapy or other serious
underlying medical condition which would impair the ability of the patient to receive
protocol treatment.

- Pregnancy or lactation.

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

- 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:

Characterize the safety profile of the new formulation of study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.

Outcome Time Frame:

Duration of study

Safety Issue:

Yes

Authority:

Canada: Health Canada

Study ID:

ARRAY-543-103

NCT ID:

NCT00637702

Start Date:

February 2008

Completion Date:

October 2012

Related Keywords:

  • Advanced Cancer
  • Neoplasms

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