Advanced Cancer
Conditions
Keywords
ErbB2+ Breast Cancer, HER2+ Breast Cancer
Brief summary
This is a Phase 1 study during which patients with advanced solid tumors will receive investigational study drug ARRY-334543. This study has 2 parts. In the first part, patients will receive increasing doses of study drug (2 dosing schedules will be evaluated) in order to achieve the highest dose possible that will not cause unacceptable side effects. Approximately 70 patients from the US and Canada will be enrolled in Part 1 (Completed). In the second part of the study, patients will receive the best dose(s) and schedule(s) of study drug determined from the first part of the study and will be followed to see what side effects the study drug causes and what effectiveness it has, if any, in treating the cancer. Approximately 40 patients from the US and Canada will be enrolled in Part 2 (Completed).
Interventions
Part 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule
Sponsors
Array Biopharma, now a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria (Part 2): * Histologically or cytologically confirmed diagnosis of ErbB2+ breast cancer, pancreatic, squamous cell head and neck, hepatocellular, hepatobiliary, glioblastoma, ovarian, prostate, upper GI, colorectal, non small cell lung, or bladder cancer or other relevant cancers if approved in advance by the Sponsor. * Measurable disease (at least 1 target lesion) according to modified RECIST. * Failed at least one previous therapeutic regimen and either no longer a candidate for standard therapy, has no standard therapy available, or chooses not to pursue standard therapy. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Must consent to allow the Sponsor access to an archival histological specimen or to have a pre-dose tumor biopsy. * Additional criteria exist. Key
Exclusion criteria
(Part 2): * Uncontrolled or symptomatic brain metastases (if a patient has brain metastases and is on steroids, the steroid dose must be stable for at least 30 days). * Use of an investigational medication or device within 30 days prior to first dose of study drug. * Major surgery within 30 days prior to first dose of study drug. * Radiotherapy or chemotherapy within 28 days prior to first dose of study drug (not including palliative radiotherapy at focal sites). * Pregnancy or lactation. * Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. Of note, if a patient has hepatocellular carcinoma, then they may be enrolled even if they are positive for hepatitis B and/or hepatitis C. * Additional criteria exist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the maximum tolerated dose (MTD) of study drug. | Part 1 |
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. | Part 1 and Part 2 |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations. | Part 1 and Part 2 |
| Assess the efficacy of the study drug in terms of tumor dimension assessment. | Part 1 and Part 2 |
Countries
Canada, United States
Outcome results
None listed