Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma (AXITINIB)
This study is currently recruiting participants.
Verified March 2013 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01334112
First received: February 14, 2011
Last updated: March 18, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatocellular Carcinoma |
Drug: Axitinib (AG-013736) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma |
Resource links provided by NLM:
Further study details as provided by University Health Network, Toronto:
Primary Outcome Measures:
- Response rate [ Time Frame: Response rate assessed by CT scan at 16 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Feasibility [ Time Frame: Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total) ] [ Designated as safety issue: Yes ]The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID
- Overall survival [ Time Frame: At the completion of trial, 1.5 years ] [ Designated as safety issue: No ]
- Response rate comparison [ Time Frame: Comparison of outcomes with RECIST criteria to Choi criteria and changes to perfusion on DCE ultrasound will occur at the end of stage 1 (after accrual of 10 patients) and trial completion ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: At trial completion, 1.5 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: At completion of trial, 1.5 years ] [ Designated as safety issue: No ]Assessed by FACT-Hep
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: At completion of trial, 1.5 years ] [ Designated as safety issue: No ]Efficacy and Toxicity in Asian vs non-Asian patients will be assessed by comparing the adverse effects profile and rate of grade 3 and grade 4 toxicity in these populations
- Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: At completion of trial, 1.5 years ] [ Designated as safety issue: Yes ]Adverse effects profile and rate of grade 3 and 4 toxicity will be assessed as a measure of safety
| Estimated Enrollment: | 29 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Axitinib
Oral Axitinib (5mg, twice daily) will be administered to all patients
|
Drug: Axitinib (AG-013736)
5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse
|
Detailed Description:
This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Unresectable and/or metastatic Hepatocellular Carcinoma
- Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
- Life expectancy of ≥12 weeks
- At least one tumor lesion
- At least 2 weeks since the end of prior systemic treatment
- No evidence of pre-existing uncontrolled hypertension
- ECOG 0 or 1
- Adequate organ function
- Not appropriate for curative therapy
- Child A or B7 cirrhosis
- CLIP score ≤ 4
Exclusion Criteria:
- Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
- Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
- Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
- Severe acute or chronic medical or psychiatric condition
- Need for treatment with prohibited drugs
- Has received local therapy to all measurable lesions
- Stage B8 or higher liver cirrhosis
- Ascites refractory to diuretic therapy
- Clinically significant ECG abnormality
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01334112
Contacts
| Contact: Cristina Palmieri, BSc | cristina.palmieri@uhn.ca |
Locations
| Canada, Alberta | |
| Foothills Hospital, Alberta Health Services | Recruiting |
| Calgary, Alberta, Canada | |
| Contact: Kelly Burak, MD, FRCPC, BSc, MSc | |
| Sub-Investigator: Oliver F Bathe, MD | |
| Principal Investigator: Kelly Burak, MD, FRCPC, BSc, MSc | |
| Sub-Investigator: Gwyn Bebb, MD | |
| Sub-Investigator: Deepak Bhayana, MD | |
| Sub-Investigator: Mark Swain, MD | |
| Sub-Investigator: Sam Lee, MD | |
| Sub-Investigator: Alex Aspinall, MD | |
| Sub-Investigator: Sasha Lupichuk, MD | |
| Sub-Investigator: Scot Dowden, MD | |
| Sub-Investigator: Jay Easaw, MD | |
| Sub-Investigator: Patricia Tang, MD | |
| Sub-Investigator: Stephanie Wilson, MD | |
| Sub-Investigator: Carla Coffin, MD | |
| Sub-Investigator: Rob Myers, MD | |
| Canada, Ontario | |
| University Health Network, Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada | |
| Principal Investigator: Jennifer Knox, MSc, FRCPC, MD | |
| Sub-Investigator: Ronald Feld, BSc, FACP, FRCPC, MD | |
| Sub-Investigator: Anne Horgan, MD | |
| Sub-Investigator: Tae Kyoung Kim, MD | |
| Sub-Investigator: Korosh Khalili, MD | |
| Sub-Investigator: Patrick Rogella, MD | |
| Sub-Investigator: Hyun-Jung Jang, MD | |
Sponsors and Collaborators
University Health Network, Toronto
Pfizer
Investigators
| Principal Investigator: | Jennifer Knox, MSc, FRCPC, MD | University Health Network, Princess Margaret Hospital |
| Principal Investigator: | Kelly Burak, MD, FRCPC, BSc, MSc | University of Calgary |
More Information
No publications provided
| Responsible Party: | University Health Network, Toronto |
| ClinicalTrials.gov Identifier: | NCT01334112 History of Changes |
| Other Study ID Numbers: | WS515376 |
| Study First Received: | February 14, 2011 |
| Last Updated: | March 18, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Hepatocellular Carcinoma Advanced Hepatocellular Carcinoma Liver Cancer Axitinib AG-013736 |
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 |
ClinicalTrials.gov processed this record on June 18, 2013