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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00604721 |
AZD6244 will be administered at a dose of 100 mg twice daily approximately 12 hours apart, in a mix and drink formulation for the first 6 patients. Patients in the safety cohort will be counted toward the efficacy endpoints.
Enrollment of patients with moderate liver dysfunction will be held when the 6th patient begins therapy (if patients are enrolled simultaneously at several sites such that the number exceeds 6, all will be included in safety cohort analysis). Upon completion of a full cycle for the 6th patient, requirements for dose reductions (according to section 6) will be analyzed. If 3 or greater patients require dose reduction, or if > 2 patients exhibit grade 3/4 non-hematologic toxicity, subsequent patients will be treated at a starting dose of 50mg PO bid. If 2 or more patients require 2 dose reductions or discontinuation of therapy during the first cycle, the study will be suspended for consideration of amendment to a formal dose escalation trial for patients with moderate liver dysfunction.
Patients with normal liver function or minimal liver dysfunction will be treated with starting doses of 100 mg PO bid beginning 48 hours after the initial dose and PK draws.
Condition | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: AZD6244 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2 Study of AZD6244 in Advanced or Metastatic Hepatocellular Carcinoma |
Estimated Enrollment: | 44 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN)
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Drug: AZD6244
AZD6244 100mg orally twice per day
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2: Experimental
near normal liver function
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Drug: AZD6244
AZD6244 100mg orally twice per day
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The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) will comprise a "moderate liver dysfunction" safety cohort. AZD6244 will be administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation.
For the purposes of evaluation, a cycle will be defined as 21 days. Patients in the safety cohort will be counted toward the efficacy endpoints.
Enrollment of patients with moderate liver dysfunction will be held when the 6th patient begins therapy (if patients are enrolled simultaneously at several sites such that the number exceeds 6, all will be included in safety cohort analysis). Upon completion of a full cycle for the 6th patient, requirements for dose reductions (according to section 6) will be analyzed. If 3 or greater patients require dose reduction, or if > 2 patients exhibit grade 3/4 non-hematologic toxicity, subsequent patients will be treated at a starting dose of 50mg PO bid. If 2 or more patients require 2 dose reductions or discontinuation of therapy during the first cycle, the study will be suspended for consideration of amendment to a formal dose escalation trial for patients with moderate liver dysfunction.
Patients with normal liver function or minimal liver dysfunction will be treated with starting doses of 100 mg PO bid beginning 48 hours after the initial dose and PK draws.
The two parts of the formulation are AZD6244, supplied as a powder in glass bottles/vials, and an aqueous solution of the Captisol® vehicle which must be mixed and reconstituted as a suspension immediately before use.
Patients will be provided with a Medication Diary for AZD6244, instructed in its use, and asked to bring the diary with them to each appointment. A new copy of the Medication Diary will be given to patients whose dose is reduced due to adverse events The patient should take AZD6244 doses on an empty stomach at least 1 hour before or 2 hours after eating. Captisol and AZD6244 can be stored at room temperature.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bert H. O'Neil, MD | (919) 966-4431 | bert_oneil@med.unc.edu |
United States, Florida | |
H Lee Moffitt Cancer Ctr | Recruiting |
Tampa, Florida, United States, 33612 | |
Contact: Chris Garrett, MD 813-745-1965 chris.garrett@moffitt.org | |
Principal Investigator: Chris Garrett, MD | |
United States, Georgia | |
Winship Cancer Inst | Recruiting |
Atlanta, Georgia, United States, 30322 | |
Contact: John S. Kauh, MD 404-778-2407 john.kauh@emoryhealthcare.org | |
Principal Investigator: John S Kauh, MD | |
United States, North Carolina | |
UNC Lineberger CCC | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Bert H. O'Neil, MD 919-966-4431 bert_oneil@med.unc.edu | |
Principal Investigator: Bert H. O'Neil, MD | |
United States, Ohio | |
OSU CCC | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Tanios Bekaii-Saab, MD 614-293-9863 tanios.bekaii-saab@osumc.edu | |
Principal Investigator: Tanios Bekaii-Saab, MD | |
United States, Tennessee | |
Vanderbilt Ingram Cancer Ctr | Recruiting |
Nashville, Tennessee, United States, 37232-6307 | |
Contact: Laura Williams, MD 615-322-4967 laura.williams@vanderbilt.edu | |
Principal Investigator: Laura Williams, MD | |
United States, Virginia | |
Massey Cancer Center, Virginia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Ruey-min R. Lee, MD, PhD 804-628-2086 rlee5@vcu.edu | |
Principal Investigator: Ruey-min R. Lee, MD, PhD |
Study Chair: | Bert H. O'Neil, MD | UNC Lineberger CCC |
Responsible Party: | Southeast Phase II Consortium ( Bert H. O'Neil, MD ) |
Study ID Numbers: | NCI#7909 |
Study First Received: | January 17, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00604721 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Hepatocellular Carcinoma AZD6244 Pharmacokinetics |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular |
Gastrointestinal Neoplasms Hepatocellular Carcinoma Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |