A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01316822
First received: December 1, 2010
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

This is a Phase 1 study during which patients with advanced cancer will receive investigational study drug ARRY-382. Patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. Approximately 50 patients from the US will be enrolled in this study.


Condition Intervention Phase
Metastatic Cancer
Drug: ARRY-382, cFMS inhibitor; oral
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms. [ Time Frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year. ] [ Designated as safety issue: Yes ]
  • Establish the maximum tolerated dose (MTD) of study drug. [ Time Frame: The MTD will be based on Cycle 1 (28 days). ] [ Designated as safety issue: Yes ]
  • Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites. [ Time Frame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the efficacy of study drug in terms of incidence of response rate and duration of response. [ Time Frame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year. ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARRY-382 Drug: ARRY-382, cFMS inhibitor; oral
multiple dose, escalating

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key 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 allowed).
  • Additional criteria exist.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316822

Locations
United States, Tennessee
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Array BioPharma
  More Information

No publications provided

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT01316822     History of Changes
Other Study ID Numbers: ARRAY-382-101
Study First Received: December 1, 2010
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Array BioPharma:
CSF1R
M-CSF
CSF-1
c-FMS
Tumor-associated macrophage
Macrophage-Colony Stimulating Factor-1
Receptor tyrosine kinase inhibitor
Tumor cell-induced osteolysis

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 30, 2014