AZD6244 and Sorafenib in Advanced Hepatocellular Carcinoma
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ClinicalTrials.gov Identifier: NCT01029418 |
Recruitment Status
:
Terminated
(The phase II portion was not conducted due to funding issue.)
First Posted
: December 10, 2009
Last Update Posted
: April 16, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatocellular Carcinoma | Drug: AZD6244 and sorafenib | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Study of AZD6244 in Combination With Sorafenib in Advanced Hepatocellular Carcinoma |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | February 2014 |
Actual Study Completion Date : | January 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: AZD6244 and sorafenib
AZD6244+ sorafenib
|
Drug: AZD6244 and sorafenib
dose escalation of AZD6244; sorafenib 400mg bd
Other Names:
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- To determine the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of the combination of AZD6244 and sorafenib in patients with advanced hepatocellular cancer. [ Time Frame: 12-15months ]
- To investigate if the combination sorafenib and AZD6244 increases Time To Progression (TTP) over sorafenib alone in patients with advanced hepatocellular carcinoma patients. [ Time Frame: 2-3 years ]

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Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with unresectable BCLC Stage B/C hepatocellular carcinoma that is biopsy-proven ( histology or cytology from prior tumor biopsy specimen is acceptable)
- Patients without prior systemic treatment ( chemotherapy or molecular targeted therapy) except prior adjuvant therapy, if given more than 6 months ago
- Patients who had prior local therapy ( TACE; PEI; RFA) more than 4 weeks prior to study entry
- No radiotherapy within 4 weeks before entry
- Child-Pugh class A only ( Appendix A)
- Age 21 years and older
- ECOG performance status 0 or 1 ( Appendix A)
- Life expectancy > 3 months.
- Patients must have normal organ and marrow function as defined below:
Absolute neutrophil count > 1.5 x 109/L;Platelets> 75 x 109/L; Haemoglobin > 9.0g/dl;Total bilirubin < 51umol/L ( 3 mg /dL); AST(SGOT)/ALT(SGPT) < 5 X institutional ULN; Creatinine 1.5 ULN; INR <1.7 or prothrombin time ( PT) <4 seconds above ULN; Left ventricular ejection fraction (LVEF) >50%
- Measurable disease according to RECIST. A lesion which has previously been locally treated (including TACE or RFA) is eligible as long as there is evidence of disease progression
- Suitable for oral administration of drug
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Prior systemic therapy including sorafenib or a MEK inhibitor or sunitinib or other investigational drugs
- Any prior local therapy ( surgery, radiation therapy, hepatic arterial embolization, or cryoablation) within 4 weeks of study entry.
- Prior liver transplant
- NCI CTCAE grade > 3 hemorrhage within 4 weeks of starting study treatment, or documented variceal hemorrhage of any grade within 12 months of study entry (as documented on endoscopy)
- Presence of esophageal varices (> Grade 2) at risk of bleeding and/or serious or non-healing wound/ulcer ( as documented by endoscopy)
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study entry
- Patients with underlying inflammatory bowel disease, partial or complete bowel obstruction or chronic diarrhea
- Any of the following within the 12 months prior to study drug administration: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, including transient ischemic attack, or pulmonary embolism.
- History of cardiac disease:
- active congestive heart failure
- cardiac arrythmias of NCI CTCAE grade >2 or requiring pacemaker
- uncontrolled hypertension
- cardiomyopathy
- atrial fibrillation rate >100bpm
- Patients with factors that increase the risk of QT prolongation or arrhythmic events ( hypokalemia, family history of long QT interval syndrome) or QTc interval of > 450ms for males or > 470ms for females on screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029418
Singapore | |
National University Hospital Singapore | |
Singapore, Singapore, 119074 | |
National Cancer Centre Singapore | |
Singapore, Singapore, 169610 |
Principal Investigator: | Su Pin Choo | National Cancer Centre, Singapore |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Choo Su Pin, Senior Consultant, National Cancer Centre, Singapore |
ClinicalTrials.gov Identifier: | NCT01029418 History of Changes |
Other Study ID Numbers: |
09-20-HEP |
First Posted: | December 10, 2009 Key Record Dates |
Last Update Posted: | April 16, 2015 |
Last Verified: | April 2015 |
Keywords provided by Choo Su Pin, National Cancer Centre, Singapore:
HCC hepatocellular carcinoma liver cancer |
Additional relevant MeSH terms:
Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Sorafenib Niacinamide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs |