Clinical Trial 18923

Cancer Type: Thoracic
Interventions:BGB324; Erlotinib; Tarceva (Erlotinib)

Study Type: Treatment
Phase of Study: Phase I/II
Investigators:

  • Alberto Chiappori

Overview

Study Title

A Multi-Center Open-Label Phase 1/2 Study of BGB324 in Combination with Erlotinib in Patients with Stage IIIb or Stage IV Non-Small Cell Lung Cancer

Summary

The purpose of this study is to test the safety of the study drug BGB324 and see what effects it has on participants and their cancer when given with erlotinib (a drug used to treat some patients with non-small cell lung cancer).

Objective

Primary Objective: To explore the safety and tolerability of single agent BGB324 in patients with NSCLC. Secondary Objectives: To explore the safety and tolerability of BGB324 administered in combination with erlotinib in patients with NSCLC. To identify the dose limiting toxicity (DLT) profile of BGB324 administered in combination with erlotinib in this population. To assess the pharmacokinetics of BGB324 and erlotinib and the potential effect of BGB324 on erlotinib.

Inclusion Criteria

  • Provision of written informed consent to participate in this investigational study
  • Histological or cytological confirmation of Stage IIIb or Stage IV (unresectable) NSCLC
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Age 18 years or older
  • Known EGFR mutation status
  • Has been receiving erlotinib for treatment of NSCLC with erlotinib-related toxicities well-controlled and less than Grade 3 in severity at screening
  • Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to taking their first dose of BGB324. Males and females of reproductive potential must agree to practice highly effective methods of contraception throughout the study and for ≥3 months after the last dose of BGB324.

  • Exclusion Criteria

  • Pregnant or lactating
  • Abnormal left ventricular ejection fraction (less than the lower limit of normal for a patient of that age at the treating institution or less than 45%)
  • Treatment with any of the following: histamine receptor two inhibitors, protocol pump inhibitors or antacids within three days or five half-lives, whichever is longer
  • History of an ischemic cardiac event including myocardial infarction within 3 months of study entry
  • NSCLC with evidence of a centrally cavitating lesion
  • Pulmonary hemorrhage or hemoptysis > 2.5 mL blood within six weeks unless cause has been addressed and is medically resolved
  • Treatment with cytotoxic chemotherapy within the preceding four weeks
  • Treatment with other non-cytotoxic agents for NSCLC in the preceding ten days or four terminal half-lives, whichever is shorter
  • Congestive cardiac failure of >Grade 2 severity according to the NYHA defined as symptomatic at less than ordinary levels of activity
  • Unstable cardiac disease, including unstable angina or unstable hypertension, as defined by the need for change in medication for lack of disease control within the last three months