A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GDC-0623 in Patients With Locally Advanced or Metastatic Solid Tumors
Completed · Phase 1
Conditions studied: Solid Cancers
In brief
This is an open-label, multicenter, Phase I dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0623 in patients with locally advanced or metastatic solid tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) followed by an expansion stage (Stage II). Stage I will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0623 administered orally on a 21 day on/7-day off dosing schedule.
Key facts
- Study ID
- NCT01106599
- Run by
- Genentech, Inc.
- People needed
- 61
- Starts
- 2010-04-01
- Expected to finish
- 2014-08-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 >= 12 weeks
- Adequate hematologic and end organ function
- Agreement to use effective form of contraception for the duration of the study
- Consent to provide archival tissue
- For the cohort expansion stage (Stage II): Patients in this cohort must have had no more than four prior systemic therapies for cancer and must have KRAS mutant CRC (Stage II A and B), pancreatic cancer (Stage IIC, or KRAS mutant NSCLC [Stage IID])
You may not qualify if…
- History of prior significant toxicity from a MEK pathway inhibitor requiring discontinuation of treatment
- History of parathyroid disorder or history of malignancy-associated hypercalcemia requiring therapy in the last 6 months
- History of retinal vein occlusion (RVO) or predisposing factors to RVO, including uncontrolled hypertension, uncontrolled diabetes, uncontrolled hyperlipidemia, and coagulopathy
- Evidence of visible retinal pathology considered a risk factor for retinal vein thrombosis
- History of glaucoma
- Palliative radiotherapy, experimental therapy, or anti-cancer therapy or major surgical procedure within a specified timeframe prior to first dose of study drug
- Current severe, uncontrolled systemic disease
- History of clinically significant cardiac dysfunction
- History of active gastrointestinal bleeding within 6 months prior to screening
- Clinically significant history of liver disease, current alcohol abuse, or current known active infection with HIV, or hepatitis B or C virus
- Active autoimmune disease
- Uncontrolled ascites
- Pregnancy, lactation, or breastfeeding
- Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms
- For the Exploratory PK Cohorts (Stage IB and Stage IC): Patients who have a history of or ongoing gastro-esophageal reflux disease or peptic ulcer, or who have gastric pathology or history of gastric surgery which could affect absorption of GDC-0623 from the stomach, will be excluded from these cohorts
Where it is running
- Study site — Los Angeles, California, United States
- Study site — Sacramento, California, United States
- Study site — Oklahoma City, Oklahoma, United States
- Study site — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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