Advanced Cancer, Pancreatic Cancer
Conditions
Brief summary
This is a 2-phase study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and gemcitabine. The study has 2 parts. In the first part of the study, Phase 1, patients with advanced/metastatic solid tumors will receive increasing doses of study drug in combination with gemcitabine in order to achieve the highest dose of study drug possible that will not cause unacceptable side effects. Patients will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 24 patients from the US will be enrolled in Part 1 (Completed). In the second part of the study, Phase 2, patients with metastatic pancreatic cancer will receive the best dose of study drug, in combination with gemcitabine, determined from the first part of the study and will be followed to see what side effects the combination causes and what effectiveness the combination has, if any, in treating the cancer. Approximately 42 patients from the US will be enrolled in Part 2 (Withdrawn).
Interventions
multiple dose, escalating
DRUGGemcitabine, nucleoside analogue; intravenous
multiple dose, single schedule
Sponsors
Array BioPharma
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 1): * Histologically or cytologically confirmed diagnosis of a solid tumor suitable for treatment with gemcitabine. * No more than 3 prior anticancer regimens for advanced disease. * Measurable or evaluable, nonmeasurable disease. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. * Able to take and retain oral medications. * Additional criteria exist. Key
Exclusion criteria
(Part 1): * 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). * Treatment with prior chemotherapy within 21 days of first dose of study drug. * Requiring IV alimentation. * Pregnancy or lactation. * Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C. * History of being unable to tolerate gemcitabine or any of its components. * Additional criteria exist.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Establish the maximum tolerated dose (MTD) of study drug in combination with gemcitabine. | Part 1 |
| Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. | Part 1 |
| Characterize the pharmacokinetics (PK) of study drug, gemcitabine and a gemcitabine metabolite. | Part 1 |
| Assess the efficacy of the study drug in combination with gemcitabine in terms of progression-free survival (PFS) at 16 weeks. | Part 2 |
Secondary
| Measure | Time frame |
|---|---|
| Assess the efficacy of the study drug in combination with gemcitabine in terms of tumor response. | Part 1 |
| Characterize the safety profile of study drug in combination with gemcitabine in terms of adverse events, clinical laboratory tests and electrocardiograms. | Part 2 |
Countries
United States
Outcome results
None listed