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An Open-Label, Phase I, Dose Escalation Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 Administered Daily in Patients with Locally Advanced or Metastatic Solid Tumors.
Closed to Accrual with Ongoing Follow-up
Defintions of terms and FAQ about clinical trials.
Anthony El-Khoueiry, M.D.
Other Trial Staff:
Anayansi Miloud, D.M., Xiomara Menendez, R.N., Arthur Alvarez, D.M., Arthur Alvarez, D.M., Molly Oswald, R.N.
to see study documents.
You may participate in this study if:
Patient must have signed and dated IRB approved informed consent and HIPAA authorization forms.
Age greater than or equal to 18 years
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
Life expectancy greater than or equal to 12 weeks
Adequate hematologic and end organ function, defined by the following laboratory results obtained within 2 weeks prior to first dose of study drug treatment: Absolute neutrophil count greater than or equal to 1500 -Platelet count greater than or equal to 100,000 -Hemoglobin greater than or equal to 9.0 -Albumin greater than or equal to 2.5 -Baseline serum phosphorus less than or equal to 6.5 -Baseline serum Ca x P product <4 or <50 Total bilirubin less than or equal to ULN AST, ALT, and alkaline phosphatase (ALP) less than or equal to 2.5 x ULN, with the following exceptions: Patients with documented liver metastases: AST and/or ALT less than or equal to 5 x ULN Patients with documented liver or bone metastases: ALP less than or equal to 5 x ULN Serum creatinine less than or equal to 1.5 x ULN and creatinine clearance greater than or equal to 50 on the basis of the Cockroft-Gault glomerular filtration rate -PT/lNR and PTTless than or equal to 1.5 x ULN Prophylactic anticoagulation for venous access devices is allowed as long as PT/INR and PTI are less than or equal to 1.5 x ULN.
For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use an effective form of contraception (e.g., surgical sterilization, a reliable barrier method, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of the study
Consent to provide archival tissue (either a paraffin-embedded tissue block or at least 15 unstained slides) for testing BRAF, NRAS, KRAS, and PI3K mutational status, as well as PI3K amplification and PTEN protein status
Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Current cancer for which patient is enrolled on study must harbor a known BRAF, NRAS, or KRAS mutation
FDG-PET avid disease on baseline scan At least one target lesion on CT must also be an FDG-PET avid region of interest
You may not participate in this study if:
History of prior significant toxicity from another MEK pathway inhibitor requiring discontinuation of treatment
History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
History of retinal vein occlusion
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, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
Allergy or hypersensitivity to components of the GDC-0623 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 (e.g., biologic or other targeted therapy, chemotherapy, or hormonal therapy) within 28 days (6 weeks for nitrosoureas or mitomycin C or 14 days for hormonal therapy or kinase inhibitors) before the first dose of study drug treatment in Cycle 1. A washout of less than 28 days may be allowed provided that the patient has adequately recovered from any clinically relevant toxicity. All acute drug-related toxicity must have resolved prior to study entry, except for alopecia and Grade 1 neuropathy.
Current severe, uncontrolled systemic disease (including but not limited to clinically significant cardiovascular, pulmonary, or renal disease, ongoing or active infection)
History of clinically significant cardiac dysfunction, including the following: -Current uncontrolled Grade greater than or equal to 2 hypertension or unstable angina -History of symptomatic congestive heart failure of any New York Heart Association class or serious cardiac arrhythmia requiring treatment, with the exceptions of atrial fibrillation and paroxysmal supraventricular tachycardia -History of myocardial infarction within 6 months prior to first dose of study drug treatment in Cycle 1 -History of congenital long QT syndrome or QTc >470 msec
Inability or unwillingness to swallow pills
History of malabsorption or other condition that would interfere with enteral absorption
Any history of active GI bleeding within the past 6 months prior to screening
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
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. Patients with a history of adequately treated brain metastases are eligible. Adequately treated brain metastases are defined as those having no ongoing requirement for medical therapy to control symptoms, and no evidence of progression or hemorrhage for greater than or equal to 2 months after radiation treatment (such as whole brain radiotherapy or radiosurgery [Gamma Knife, L1NAC, or equivalent]) and/or greater than or equal to 3 months after surgical treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or CT scan) during the screening period. Any medical therapy for brain metastases (e.g., steroids or seizure medications) must have been discontinued without the subsequent appearance of symptoms for greater than or equal to 4 weeks before first dose of study drug treatment in Cycle 1.
Inability to comply with study and procedures
Any history of, or ongoing malignancy, that would potentially interfere with the interpretation of the PO or efficacy assays.
Need to take a concomitant medication, dietary supplement, or food that is prohibited during the study
For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.