A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumours or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Official Title

An Open-Label, Phase I/II, Dose-Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumours or Non-Hodgkin's Lymphoma and in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Summary:

This is an open-label, multicentre, Phase I/II study to assess the safety, tolerability, and pharmacokinetics of GDC-0032. The Phase I portion will be divided into two stages. During Stage 1, GDC-0032 will be administered every day orally (PO) and at escalating doses in participants with locally advanced or metastatic solid tumours. During Stage 2, GDC-0032 will be administered alone or as combination therapy within indication-specific cohorts. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female participants with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative, hormone receptor-positive breast cancer.

Trial Description

Primary Outcome:

  • Area under the concentration-time curve (AUC) of GDC-0032
  • Minimum observed concentration (Cmin) of GDC-0032
  • Maximum observed concentration (Cmax) of GDC-0032
  • Incidence of adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE v4.0) grade and associated dose of GDC-0032
  • Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE v4.0 grade and associated dose of GDC-0032
  • Incidence of Grade 3 and 4 abnormalities in safety-related laboratory parameters and associated dose of GDC-0032
  • Phase II: Clinical benefit rate with the combination GDC-0032 + fulvestrant
  • Phase II: Objective response rate with the combination GDC-0032 + fulvestrant
Secondary Outcome:
  • Phase I: Best overall response
  • Phase I: Duration of objective response
  • Phase I: Progression-free survival (PFS)
  • Phase II: Duration of response with the combination GDC-0032 + fulvestrant
  • Phase II: PFS with the combination GDC-0032 + fulvestrant
  • Phase II: Overall survival with the combination GDC-0032 + fulvestrant

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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