A Study of ARRY-334543 and Capecitabine in Patients With Advanced Cancer
Overview
- Phase
- Phase 1
- Intervention
- ARRY-334543, EGFR/ErbB2 inhibitor; oral
- Conditions
- Advanced Cancer
- Sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This is a Phase 1 study during which patients with advanced/metastatic solid tumors will receive investigational study drug ARRY-334543 and capecitabine. Patients will receive increasing doses of study drug in combination with capecitabine 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 30 patients from the US and Canada will be enrolled in this study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed diagnosis of any advanced/metastatic cancer suitable for treatment with capecitabine. Pancreatic cancer is not allowed and patients with gastric or gastroesophageal junction (GEJ) cancer are only eligible if prior treatment did not include a total gastrectomy.
- •Target lesions may be in a previously irradiated field only if progression of the lesion has been clearly documented.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or
- •Must be able to take and retain oral medications.
- •Additional criteria exist.
Exclusion Criteria
- •Active concomitant malignancies.
- •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).
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Requiring intravenous (IV) alimentation.
- •Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or hepatitis C.
- •Pregnancy or lactation.
- •Chemotherapy, anticancer immunotherapy, monoclonal antibodies or biologics within 21 days prior to first dose of study drug.
- •Anti-EGFR and/or ErbB2 small molecule targeted therapy or hormonal anticancer therapy within 14 days prior to first dose of study drug.
- •History of any hypersensitivity to or intolerance of capecitabine or any of its components, or to fluorouracil or any fluoropyrimidine therapy.
- •Additional criteria exist.
Arms & Interventions
ARRY-334543 + capecitabine
Intervention: ARRY-334543, EGFR/ErbB2 inhibitor; oral
ARRY-334543 + capecitabine
Intervention: Capecitabine, 5-fluorouracil prodrug; oral
Outcomes
Primary Outcomes
Characterize the safety profile of study drug in combination with capecitabine in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time Frame: Duration of study
Characterize the pharmacokinetics (PK) of study drug and capecitabine.
Time Frame: Duration of study
Establish the maximum tolerated dose (MTD) of study drug in combination with capecitabine.
Time Frame: Duration of study
Secondary Outcomes
- Assess potential predictive biomarkers of clinical activity for the study drug in combination with capecitabine.(Duration of study)
- Assess the efficacy of the study drug in combination with capecitabine in terms of tumor response and changes in serological tumor markers.(Duration of study)