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

NCT ID: NCT01316822

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-10-31

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.

Conditions

Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARRY-382

Group Type: EXPERIMENTAL

ARRY-382, cFMS inhibitor; oral

Intervention Type: DRUG

multiple dose, escalating

Interventions

ARRY-382, cFMS inhibitor; oral

multiple dose, escalating

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Array Biopharma, now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Sarah Cannon Research Institute

Nashville, Tennessee, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ARRAY-382-101

Identifier Type: -

Identifier Source: org_study_id