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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Histologically or cytologically documented, locally advanced or metastatic solid tumors for which standard therapy either does not exist or has proven ineffective or intolerable
Evaluable disease or disease measurable
Life expectancy \> or = 12 weeks
Adequate hematologic and end organ function
For female patients of childbearing potential and male patients with partners of childbearing potential, use of an effective form of contraception with continued use for study duration and up to 3 months or more following discontinuation of treatment drug
Fluorodeoxyglucose positron emission tomography (FDG-PET) avid disease on baseline scan
For enrollment in part 2, patients must meet all of the following:
Measurable disease
No more than four prior systemic therapies for locally advanced or metastatic cancer
You may not be if
History of prior significant toxicity from another MEK inhibitor or ERK inhibitor requiring discontinuation of treatment
Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis
History of glaucoma
Intraocular pressure \> 21 mmHg as measured by tonometry
Predisposing factors to retinal vein occlusion (RVO)
History of RVO, neurosensory retinal detachment, or neovascular macular degeneration
Allergy or hypersensitivity to components of the cobimetinib or GDC-0994 formulation
Palliative radiotherapy within 2 weeks prior to first dose of study-drug treatment in Cycle 1
Experimental therapy within 4 weeks prior to first dose of study-drug treatment in Cycle 1
Major surgical procedure or significant traumatic injury within 4 weeks prior to the first dose of study-drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
Anti-cancer therapy within 28 days prior to the first dose of study-drug treatment in Cycle 1
Current severe, uncontrolled systemic disease
History of clinically significant cardiac dysfunction
History of symptomatic congestive heart failure or serious cardiac arrhythmia requiring treatment
History of myocardial infarction within 6 months prior to the first dose of study-drug treatment in Cycle 1
History of congenital long QT syndrome or QTc \> 470 msec
LVEF
History of malabsorption or other condition that would interfere with enteral absorption
Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
Any condition requiring warfarin or thrombolytic anticoagulants
Active autoimmune disease
Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Pregnancy, lactation, or breastfeeding
Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the Pharmacodynamic (PD) or efficacy assays
Clareo Health | A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
