A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast 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
Phase I (Cohorts A through D, G, H, T, T2 and X): Histologically documented, locally advanced or metastatic solid malignancy or NHL 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 I (Cohorts E and F): Post-menopausal females with locally advanced or metastatic hormone receptor-positive breast cancer that has progressed or failed to respond to at least one prior endocrine therapy in the adjuvant or metastatic setting
Phase I (Cohorts J through S): Post-menopausal females with HER2-negative, hormone-receptor positive breast cancer that has progressed or failed to response to at least one prior endocrine therapy in the adjuvant or metastatic setting
Phase II: Post-menopausal female participants with locally advanced or metastatic HER2-negative, hormone receptor-positive breast cancer
Phase I (Cohorts A through S) and Phase II: Evaluable or measurable disease per RECIST version 1.1
Phase I (Cohorts T, and T2): Greater than or equal to (\>/=) 1 bi-dimensionally measurable lesion on computed tomography (CT) scan
Phase I (Cohort T): Participants with non-Hodgkin's lymphoma, regardless of PIK3CA mutation status
Phase 1 (Cohort T2): Participants with diffuse large B-cell lymphoma (DLBCL), regardless of PIK3CA mutation status
Phase I (Cohort X): Participants with PIK3CA-mutant tumors and 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 28 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
You may not be if
Known and untreated, or active central nervous system (CNS) metastases (progressing or requiring treatment)
Active congestive heart failure or ventricular arrhythmia requiring medication
Participants requiring any daily supplemental oxygen
Active inflammatory disease requiring immunosuppressants, including small or large intestinal inflammation such as Crohn's disease or ulcerative colitis
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Treatment with chemotherapy less than or equal to (\</=) 3 weeks before study treatment
Oral endocrine therapy \</= 2 weeks before study treatment
Treatment with investigational drug \</= 3 weeks or 5 half-lives before study treatment
Treatment with biologic therapy \</= 3 weeks before study treatment
Treatment with kinase inhibitors \</= 2 weeks before study treatment
Radiation therapy (other than radiation to bony metastases) as cancer therapy \</= 4 weeks before study treatment
Palliative radiation therapy to bony metastases \</= 2 weeks before study treatment
Major surgery \</= 4 weeks before study treatment
Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or renders the participant at high risk from treatment complications (examples include but are not limited to clinically significant non-healing wound, active bleeding, or ongoing fistula or active tuberculosis infection)
Clareo Health | A Dose Escalation Study Evaluating the Safety and Tolerability of GDC-0032 in Participants With Locally Advanced or Metastatic Solid Tumors or Non-Hodgkin's Lymphoma (NHL) and in Combination With Endocrine Therapy in Locally Advanced or Metastatic Hormone Receptor-Positive Breast Cancer
