Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT01875705
Eligibility Criteria:
Inclusion Criteria:
* 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 per RECIST 1.1
* Life expectancy \>= 12 weeks
* Adequate hematologic and end organ function
* Consent to provide archival tissue
Exclusion Criteria:
* History of prior significant toxicity from another MEK or ERK inhibitor requiring discontinuation of treatment
* History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
* Evidence of visible retinal pathology as assessed by ophthalmologic examination that is considered a risk factor for retinal vein thrombosis or neurosensory retinal detachment
* History of glaucoma
* Intraocular pressure \> 21 mmHg as measured by tonometry
* Predisposing factors to retinal vein occlusion, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
* History of retinal vein occlusion (RVO), neurosensory retinal detachment, or neovascular macular degeneration
* Allergy or hypersensitivity to components of the 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 first dose of study drug treatment in Cycle 1, or anticipation of the need for major surgery during the course of study treatment
* Prior anti-cancer therapy within 28 days or 5 times the half-life whichever is longer
* Current severe, uncontrolled systemic disease
* History of clinically significant cardiac dysfunction
* Pregnancy, lactation, or breastfeeding
* Active autoimmune disease
* Inability or unwillingness to swallow pills
* Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
* Clinically significant history of liver disease (including cirrhosis), current alcohol abuse, or current known active infection with HIV, hepatitis B virus, or hepatitis C virus
* Any condition requiring warfarin or thrombolytic anticoagulants
* Uncontrolled ascites requiring weekly large volume paracentesis for 3 consecutive weeks prior to enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01875705
Study Brief:
Protocol Section:
NCT01875705