A Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas (Axi-STS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01140737|
Recruitment Status : Active, not recruiting
First Posted : June 9, 2010
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Drug: Axitinib||Phase 2|
Soft tissue sarcomas are a heterogeneous group of rare malignancies that account for 0.72% of new malignancies and 0.65% of malignant deaths. Advanced sarcomas carry a poor prognosis. Angiogenesis is a hallmark of tumour growth, and there is increasing evidence that antiangiogenic drugs, including axitinib, can lead to tumour regression and improve patient survival in a variety of tumours.
Patients with angiosarcoma, synovial sarcoma, leiomyosarcoma and other sarcomas will be separately evaluated.
Patients will take axitinib 5mg tablets by mouth twice daily. This will be continued for 2 years or until disease progression, or development of limiting toxicity. In the event of severe toxicity, axitinib will be stopped until the toxicity has improved. Treatment may be interrupted for a maximum of 2 weeks. Following this, axitinib can be restarted at a lower dose of 3 mg twice daily. If the toxicity has not improved sufficiently, axitinib will be permanently stopped.
Patients will be monitored once weekly for the first month, then at 4 week intervals. Toxicity will be closely monitored. At each clinic visit, patients will have a physical examination and a routine blood test. A Chest x-ray, CT and/or MRI scans will be done before study entry, then every 12 weeks and at the end of treatment. Disease evaluation will be carried out 12 weeks after study entry, then every 12 weeks until disease progression. After disease progression, patients will be followed up every 3 months for survival. Patients will be followed up until death or a minimum follow up period of 1 year.
Patients will be enrolled from hospitals all over the UK.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||145 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinicopathological Phase II Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||December 2018|
Patients will take axitinib tablets 5 mg by mouth twice daily continuously. There may be one dose reduction to 3mg twice daily.
Patients will take axitinib tablets 5 mg by mouth twice daily continuously. There may be one dose reduction to 3mg twice daily. A four week dosing period will be considered as 1 cycle of treatment. Axitinib treatment will be continued until disease progression, or the development of limiting toxicity.
Other Name: AG-013736
- Progression-free survival rate at 12 weeks after starting treatment, defined according to the Response Evaluation Criteria In Solid Tumours(RECIST criteria) [ Time Frame: 12 weeks after trial entry, the final analysis of the primary outcome measure will take place after all patients have been followed for a minimum of 12 weeks ]Disease will be assessed by CT or MRI scan 12 weeks after entry to trial and will be compared to disease measured by CT or MRI scan on entry to the trial or within 4 weeks prior to entry. Response at 12 weeks will be measured using RECIST criteria. Progression-free survival rate is measured as the number of patients who are alive and progression-free at 12 weeks divided by the total number of patients who received at least one cycle of treatment
- Tumour response rate (using RECIST criteria) [ Time Frame: 12 weeks and final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year. ]Disease will be assessed at 12 weeks by CT or MRI scan and clinical photographs where indicated, and compared with disease measured at baseline. Response will be measured using RECIST criteria. Tumour response rate is defined as the number of patients who achieved a complete or partial response divided by the total number of patients who received at least one cycle of treatment.
- Progression-free interval [ Time Frame: final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year. ]Progression-free interval is defined as the time from trial entry to date when disease progression first observed where progression is defined in terms of RECIST criteria. Patients who die of disease without disease progression being recorded are defined as progression at date of death. Those that die of other causes are censored at date of death and those who are alive with no recorded progression at time of analysis are censored at date last seen alive and progression-free.
- Progression-free survival time [ Time Frame: final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year. ]Progression-free survival time is defined in the same way as progression-free interval except that all deaths, whatever the cause, are included as events in the analysis.
- Overall survival time [ Time Frame: final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year. ]Survival time is measured from trial entry to death from any cause or to date last seen alive for those patients who are still alive at the time of analysis.
- Change in performance status [ Time Frame: final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year. ]Changes in performance status from baseline according to the World Health Organisation (WHO) performance status scale.
- Toxicity rate [ Time Frame: final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year. ]Adverse events will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Toxicity rate is defined as the number of patients experiencing at least one grade 3, 4 or serious adverse reaction divided by the total number of patients who started treatment
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): NCT01140737
|Aberdeen Royal Infirmary|
|Aberdeen, Scotland, United Kingdom|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom|
|Bristol Haematology & Oncology Centre|
|Bristol, United Kingdom|
|St. James's Hospital|
|Leeds, United Kingdom|
|Royal Marsden Hospital|
|London, United Kingdom|
|London, United Kingdom|
|University College London Hospitals|
|London, United Kingdom|
|Manchester, United Kingdom|
|Nottingham City Hospital|
|Nottingham, United Kingdom|
|Oxford, United Kingdom|
|Sheffield, United Kingdom|
|Southampton General Hospital|
|Southampton, United Kingdom|
|Clatterbridge Centre for Oncology|
|Wirral, United Kingdom|
|Principal Investigator:||Penella Woll, BMedSci||Weston Park Hospital, Sheffield, UK|