A Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas
Axi-STS
A Clinicopathological Phase II Study of Axitinib in Patients With Advanced Angiosarcoma and Other Soft Tissue Sarcomas
2 other identifiers
interventional
145
1 country
13
Brief Summary
The study objective is to evaluate the therapeutic activity, safety and tolerability of axitinib in patients with advanced/metastatic soft tissue sarcoma who are unsuitable for or have relapsed after standard chemotherapy. The therapeutic activity will be separately assessed in angiosarcoma, synovial sarcoma, leiomyosarcomas and other sarcomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2010
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2010
CompletedFirst Posted
Study publicly available on registry
June 9, 2010
CompletedStudy Start
First participant enrolled
August 31, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2019
CompletedMarch 18, 2021
February 1, 2019
5.8 years
June 8, 2010
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival rate at 12 weeks after starting treatment, defined according to the Response Evaluation Criteria In Solid Tumours(RECIST criteria)
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
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
Secondary Outcomes (6)
Tumour response rate (using RECIST criteria)
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.
Progression-free interval
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
final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year.
Overall survival time
final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year.
Change in performance status
final analysis of all outcome measures will take place after all patients have been followed up for a minimum of 1 year.
- +1 more secondary outcomes
Study Arms (1)
Axitinib
EXPERIMENTALPatients will take axitinib tablets 5 mg by mouth twice daily continuously. There may be one dose reduction to 3mg twice daily.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Pathologically confirmed soft tissue sarcoma, including:
- Angiosarcoma, including intermediate and malignant vascular tumours (WHO classification, 2002) and Kaposi's sarcoma.
- Leiomyosarcoma, including uterine, skin or non organ origin.
- Synovial sarcoma.
You may not qualify if:
- Locally advanced or metastatic disease incurable by surgery or radiotherapy.
- Measurable disease according to RECIST criteria.
- Evidence of objective disease progression in the past 6 months, without anticancer treatment since progression.
- Patients ineligible for chemotherapy (eg. through age, clinical condition or patient refusal) or who have received no more than two prior chemotherapy regimens.
- Age \>or = 16.
- WHO performance status 0, 1 or 2.
- At least 4 weeks from prior anticancer treatment (surgery, radiotherapy and systemic therapies) and full recovery from all their adverse effects.
- No evidence of preexisting uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be \< or = 140 mm Hg, and the baseline diastolic blood pressure readings must be \< or = 90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- Adequate physiological function:
- renal : calculated or measured creatinine clearance \> or = 50 ml/min using the Cockcroft-Gault formula (see appendix 5).
- haematological: Absolute Neutrophil Count (ANC) \> or = 1.5 x 109/L, platelets \> or = 100 x 109/L, International Normalized Ratio (INR) \< or = 1.2.
- hepatic: bilirubin within normal range, AST and ALT \< or = 3 x upper limit of normal.
- cardiac: Left Ventricular Ejection Fraction (LVEF) measured by Echocardiogram or Multi Gated Acquisition Scan (MUGA) within normal range.
- Urinary protein \<2+ by urine dipstick. If dipstick is \>2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is \<2 g per 24 hours.
- Negative pregnancy test and agrees to comply with contraceptive measures
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheffield Teaching Hospitals NHS Foundation Trustlead
- University of Birminghamcollaborator
- Cancer Research UKcollaborator
- Pfizercollaborator
Study Sites (13)
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
Royal Marsden
London, United Kingdom
University College London Hospitals
London, United Kingdom
Christies
Manchester, United Kingdom
Clatterbridge Centre for Oncology
Metropolitan Borough of Wirral, United Kingdom
Nottingham City Hospital
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Penella Woll
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Penella Woll, BMedSci
Weston Park Hospital, Sheffield, UK
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2010
First Posted
June 9, 2010
Study Start
August 31, 2010
Primary Completion
June 11, 2016
Study Completion
January 8, 2019
Last Updated
March 18, 2021
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share