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Phase 1
18 Years
Not Enrolling
Metastatic Cancer

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Trial Information


Inclusion Criteria:

- A histologically or cytologically confirmed diagnosis of advanced or metastatic solid
cancer refractory to standard treatment, for which no standard therapy is available
or for which the patient refuses standard therapy.

- Measurable disease or evaluable, nonmeasurable disease.

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

- Hemoglobin ≥ 9.0 g/dL, ANC > 1500/uL and platelet count ≥ 100,000/uL.

- AST/serum glutamic oxaloacetic transaminase (SGOT) and ALT/serum glutamic pyruvic
transaminase (SGPT) ≤ 2.5 × the upper limit of normal (ULN).

- Bilirubin ≤ ULN.

- Serum creatinine ≤ 1.5 × ULN.

- Potassium, magnesium and calcium (corrected calcium when serum albumin levels are
abnormal) within the normal range.

- Additional criteria exist.

Key Exclusion Criteria:

- 12-lead ECG demonstrating a mean QTcF > 450 msec (triplicate assessment) at the
Screening Visit or history/evidence of long QT syndrome.

- History of acute coronary syndromes, including unstable angina, coronary angioplasty,
or stenting, within the past 24 weeks.

- Use of concomitant medications that prolong the QT/QTc interval, as assessed by the
Investigator, within 14 days prior to first dose of study drug.

- Use of concomitant medication that is a strong CYP3A inhibitor or inducer within 14
days prior to first dose of study drug.

- Class II, III or IV heart failure as defined by the New York Heart Association (NYHA)
functional classification system.

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

- Active refractory nausea and vomiting, chronic gastrointestinal diseases (e.g.,
inflammatory bowel disease) or significant bowel resection that, in the judgment of
the Investigator, would preclude adequate absorption (a previous Whipple procedure is

- Additional criteria exist.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.

Outcome Time Frame:

Safety will be characterized for the duration of time that each patient stays on study; estimated one year.

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2011

Completion Date:

October 2012

Related Keywords:

  • Metastatic Cancer
  • CSF1R
  • M-CSF
  • CSF-1
  • c-FMS
  • Tumor-associated macrophage
  • Macrophage-Colony Stimulating Factor-1
  • Receptor tyrosine kinase inhibitor
  • Tumor cell-induced osteolysis
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Sarah Cannon Research InstituteNashville, Tennessee  37203
South Texas Accelerated Research Therapeutics (START)San Antonio, Texas  78229