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

December 1, 2010
October 23, 2012
March 2011
October 2012   (final data collection date for primary outcome measure)
  • 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 ]
  • Characterize the safety profile 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 ]
Complete list of historical versions of study NCT01316822 on ClinicalTrials.gov Archive Site
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 ]
  • Assess the dosing schedule(s) for study drug. [ 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
Not Provided

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Cancer
Drug: ARRY-382, cFMS inhibitor; oral
multiple dose, escalating
Experimental: ARRY-382
Intervention: Drug: ARRY-382, cFMS inhibitor; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
October 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01316822
ARRAY-382-101
Not Provided
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP