Status:
COMPLETED
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
Lead Sponsor:
Genentech, Inc.
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors. Patients wi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 21 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2016
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01875705
Start Date
June 21 2013
End Date
September 23 2016
Last Update
April 6 2018
Active Locations (4)
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1
Yale Cancer Center; Medical Oncology
New Haven, Connecticut, United States, 06520
2
Karmanos Can Inst
Detroit, Michigan, United States, 48201
3
Sarah Cannon Research Inst.
Nashville, Tennessee, United States, 37203
4
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, France, 94805