Clinical trial NCT01316822: A Study of ARRY-382 in Patients With Selected Advanced or Metastatic Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Array BioPharma
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.
timeFrame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
measure: Establish the maximum tolerated dose (MTD) of study drug.
timeFrame: The MTD will be based on Cycle 1 (28 days).
measure: Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.
timeFrame: Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Secondary outcomes:
measure: Assess the efficacy of study drug in terms of incidence of response rate and duration of response.
timeFrame: All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics (START)
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: