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A Phase I Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Patients With Locally Advanced or Metastatic Solid Tumors And in Combination With Endocrine Therapy in Patients With Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer

Conditions

Anus | Bladder | Breast - Female | Breast - Male | Cervix Uteri | Colon | Esophagus | Kidney | Larynx | Liver | Lung | Other Digestive Organ | Other Endocrine System | Other Female Genital | Other Male Genital | Other Respiratory and Intrathoracic Organs

Trial Phase

Phase I

Trial Purpose and Description

Trial Purpose

This is an open-label, multicenter, Phase I, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0032 administered every day orally (PO) in patients with locally advanced or metastatic solid tumors. In Phase II of the study, the efficacy and safety of the combination GDC-0032 and fulvestrant will be evaluated in post-menopausal female patients with locally advanced or metastatic hormone receptor-positive breast cancer.


Participation Guidelines

Age:
Gender:
Female

Eligibility Criteria

Inclusion Criteria:

  • Histologically documented, locally advanced or metastatic solid malignancy that has progressed or failed to respond to at least one prior regimen and are not candidates for regimens known to provide clinical benefit
  • Phase II: Post-menopausal female patients with locally advanced or metastatic hormone receptor-positive breast cancer
  • Evaluable or measurable disease per RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at screening
  • Life expectancy of >= 12 weeks
  • Adequate hematologic and organ function within 14 days prior to initiation of study treatment
  • Documented willingness to use an effective means of contraception for both men and women while participating in the study
Sponsor:
Genentech, Inc.
Dates:
09/04/2013
Last Updated:
Study HIC#:
1306012166