Clareo Health | A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
A Dose-escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer or Non-small Cell Lung Cancer
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age \>=18 years
For paclitaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease
For docetaxel combination arms: histologically or cytologically documented adenocarcinoma of the breast with locally recurrent or metastatic disease or histologically documented advanced (Stage IV) or recurrent NSCLC
For participants with breast cancer: HER2-negative disease as defined by local clinical guidelines
Participants with NSCLC to be treated with docetaxel need to have received at least one prior anti-cancer treatment regimen in an advanced setting and to have docetaxel be considered appropriate treatment
Evaluable or measurable disease per response evaluation criteria in solid tumors (RECIST) v.1.1
Life expectancy \>=12 weeks
Eastern cooperative oncology group (ECOG) performance status of 0 or 1 at screening
Adequate hematologic and end organ function
Use of highly effective form of contraception
You may not be if
Prior anti-cancer therapy
Prior treatment with phosphoinositide 3-kinase (PI3K) inhibitor
Known significant hypersensitivity to any components of study treatment
Grade \>=2 peripheral neuropathy
Type 1 or Type 2 diabetes
Grade \>=2 hypercholesterolemia or hypertriglyceridemia
Congenital long QT syndrome
Active congestive heart failure or ventricular arrhythmia
