Full TitleAn Open-Label, Phase I/II, 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 (Version date 29-SEP-2016)
GDC-0032 is an investigational drug that works by inhibiting PI3 kinase (PI3K), an enzyme that fuels the growth of some types of cancer. Researchers are evaluating GDC-0032 alone and in combination with other therapies in patients with advanced cancer. GDC-0032 is a pill that is taken orally (by mouth).
In the phase I study, researchers are evaluating the safety and effectiveness of GDC-0032 in patients with advanced solid tumors that have extra copies of the PI3K gene.
In the phase II study, patients with breast cancer that is positive for the estrogen receptor and negative for HER2 which has continued to grow despite aromatase inhibitor therapy will receive GDC-0032 in combination with fulvestrant. Fulvestrant is already approved for the treatment of women with hormone receptor-positive breast cancer that continues to grow after hormonal therapy. It is given by injection.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- For the phase I study, patients must have an advanced solid tumor that has extra copies of the PI3K gene.
- For the phase II study, patients must have estrogen receptor-positive HER2-negative locally advanced or metastatic breast cancer that has continued to grow despite aromatase inhibitor therapy.
- At least 3 weeks must have passed since completion of chemotherapy and 4 weeks since major surgery or radiation therapy and entry into the study.
- Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
- This study is open to patients age 18 and older.