Back to resultsA Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
Primary Purpose
Metastatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARRY-382, cFMS inhibitor; oral
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring CSF1R, M-CSF, CSF-1, c-FMS, Tumor-associated macrophage, Macrophage-Colony Stimulating Factor-1, Receptor tyrosine kinase inhibitor, Tumor cell-induced osteolysis
Eligibility 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.
Sites / Locations
- Sarah Cannon Research Institute
- South Texas Accelerated Research Therapeutics (START)
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ARRY-382
Arm Description
Outcomes
Primary Outcome Measures
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.
Establish the maximum tolerated dose (MTD) of study drug.
Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.
Secondary Outcome Measures
Assess the efficacy of study drug in terms of incidence of response rate and duration of response.
Full Information
NCT ID
NCT01316822
First Posted
December 1, 2010
Last Updated
September 17, 2020
Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01316822
Brief Title
A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array Biopharma, now a wholly owned subsidiary of Pfizer
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
CSF1R, M-CSF, CSF-1, c-FMS, Tumor-associated macrophage, Macrophage-Colony Stimulating Factor-1, Receptor tyrosine kinase inhibitor, Tumor cell-induced osteolysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARRY-382
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ARRY-382, cFMS inhibitor; oral
Intervention Description
multiple dose, escalating
Primary Outcome Measure Information:
Title
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.
Title
Establish the maximum tolerated dose (MTD) of study drug.
Time Frame
The MTD will be based on Cycle 1 (28 days).
Title
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.
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics (START)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
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