Clareo Health | Evaluating the Safety and Tolerability of GDC-0349 in Patients With Locally Advanced or Metastatic Solid Tumors or Non Hodgkin's Lymphoma
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
Histologically documented, locally advanced or metastatic solid malignancy or NHL without leukemic phase that has progressed or failed to respond to at least one prior regimen and/or are not candidates for regimens known to provide clinical benefit
ECOG performance status of 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 and for 90 days after the last dose of GDC-0349
Willingness to provide archival tumor tissue
You may not be if
Leptomeningeal disease as the only manifestation of the current malignancy
History of Type 1 or 2 diabetes requiring daily medication
Known untreated central nervous system (CNS) malignancies or treated brain metastases that are not radiographically stable for \>= 3 months prior to initiation of study treatment
Active congestive heart failure or ventricular arrhythmia requiring medication
Uncontrolled ascites requiring weekly large-volume paracentesis for 3 consecutive weeks prior to initiation of study treatment
Active infection requiring intravenous (IV) antibiotics
Patients requiring any daily supplemental oxygen
Uncontrolled hypomagnesemia or hypokalemia
Any condition requiring anti-coagulants such as warfarin, heparin, or anti-thrombotics. Prophylactic anti-coagulation and/or local application of thrombolytic agents for catheter patency may be allowed for patients with normal INR and with prior approval from the Medical Monitor
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Known human immunodeficiency virus (HIV) infection
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 patients at high risk from treatment complications
Significant traumatic injury within 3 weeks prior to initiation of GDC-0349
Major surgical procedure within 4 weeks prior to initiation of GDC-0349
Treatment with chemotherapy, hormonal therapy (except GnRH agonists or antagonists for prostate cancer), immunotherapy, biologic therapy, or radiation therapy (except palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of study treatment. Kinase inhibitors, approved by national regulatory authorities, may be used up to 2 weeks prior to initiation of GDC-0349, provided that any drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor.
Palliative radiation to bony metastases within 2 weeks prior to initiation of GDC-0349
Treatment with an investigational agent within 4 weeks prior to initiation of GDC-0349
Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy
