Phase II Study on Axitinib in Advanced Solitary Fibrous Tumor
Primary Purpose
Solitary Fibrous Tumor
Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Axitinib
Sponsored by
About this trial
This is an interventional treatment trial for Solitary Fibrous Tumor
Eligibility Criteria
Inclusion Criteria:
- Pat centrally confirmed diagnosis of solitary fibrous tumor
- Expression of PDGFRB and/or VEGFR2 by immunohistochemistry on formalin fixed-paraffin embedded (FFPE) material as minimal requirement. Activation of PDGFRB and/or VEGFR2 by real time C reactive protein of PDGFB and VEGFA on FFPE material (if in sufficient quantity) or by biochemistry on frozen material (if available)
- Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
- Measurable disease
- Centrally confirmed evidence of progression by RECIST during the 6 months before study entry
- 1st-line vs 3-rd-line
- Eastern Cooperative Oncology Group (ECOG) Performance Status = 0, 1, 2
- Adequate bone marrow function, defined as the following: absolute neutrophil count (ANC) >1.5 x 109/L, platelets >100 x 109/L, Hb >9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level
- Adequate organ function, defined as the following: total bilirubin within normal institutional limits (but in case of Gilbert's syndrome), aspartate aminotransferase (AST) and Serum Glutamic Pyruvic Transaminase (ALT) <2.5 x upper normal limit (UNL), creatinine <1.5 x upper normal limit (UNL), within normal institutional limits or creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Cardiac ejection fraction ≥50% as measured by echocardiogram
- Age > 18 yrs
- Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug
- No history of arterial and/or venous thromboembolic event within the previous 12 months
- Written, voluntary informed consent
Exclusion Criteria:
- Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
- Previous treatment with any other investigational or not investigational agents and or radiation therapy within 28 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Major surgery within 2 weeks prior to study entry
- Previous radiotherapy to ≥25 % of the bone marrow
- Concomitant other investigational agents or concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., history of uncontrolled or symptomatic angina, history of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation, myocardial infarction < 6 months from study entry, uncontrolled or symptomatic congestive heart failure, ejection fraction below the institutional normal limit)
- Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Known diagnosis of human immunodeficiency virus (HIV) infection
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Axitinib
- Expected non-compliance to medical regimens
Sites / Locations
- Fondazione IRCCS Istituto Naazionale dei Tumori
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Axitinib
Arm Description
Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.
Outcomes
Primary Outcome Measures
Response rate by Choi criteria
response rate, according to Choi Criteria
Secondary Outcome Measures
Response rate by RECIST criteria
response rate according to RECIST
Full Information
NCT ID
NCT02261207
First Posted
January 30, 2014
Last Updated
September 22, 2021
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
1. Study Identification
Unique Protocol Identification Number
NCT02261207
Brief Title
Phase II Study on Axitinib in Advanced Solitary Fibrous Tumor
Official Title
Phase II Study on Axitinib in Advanced VEGFR and/or PDGFR Solitary Fibrous Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an investigator initiated, open label, prospective, non-randomized, phase II trial aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.
Detailed Description
This is an investigator initiated, open label, prospective, non-randomized, phase II trial aimed at evaluating the activity of Axitinib in progressive VEGFR2 and/or PDGFRB positive advanced Solitary Fibrous Tumor (SFT) patients. Patients with a documented and centrally reviewed pathologic and radiologic diagnosis of progressive VEGFR2 and/or PDGFRB positive advanced SFT may enter in the study. Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.
The activity of Axitinib will be evaluated in terms of overall response rate according to Choi Criteria as defined for GIST patients treated with Imatinib, extended even to MRI.
Secondary objectives of the study will be: response rate by RECIST, progression free survival, overall survival, clinical benefit (RECIST Complete Response + Partial Response + Stable Disease >6 months). Whenever possible a post-treatment biopsy will be performed to assess Axitinib targets status after treatment and to correlate their status to the response.
Tumor assessment with CT scan and/or MRI will be performed within 4 weeks prior to first dose of Axitinib and after 4 weeks from starting treatment, then every 2 months until progression or toxicity.
As per protocol the experimental treatment can be administered in front or further line.
The study will be considered positive if 30% of response rate by Choi criteria is observed. To this end a maximum of 16 evaluable patients will be enrolled in two years.
In case of positive study the trial will be re-open to confirm the result in a larger number of patients.
.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Fibrous Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Axitinib
Arm Type
Experimental
Arm Description
Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.
Intervention Type
Drug
Intervention Name(s)
Axitinib
Other Intervention Name(s)
Inlyta
Intervention Description
Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.
Primary Outcome Measure Information:
Title
Response rate by Choi criteria
Description
response rate, according to Choi Criteria
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Response rate by RECIST criteria
Description
response rate according to RECIST
Time Frame
4 years
Other Pre-specified Outcome Measures:
Title
Overall survival
Description
Evaluation of overall survival
Time Frame
4 years
Title
Progression Free Survival
Description
Evaluation of Progression Free Survival
Time Frame
4 years
Title
Clinical Benefit
Description
Evaluation of clinical benefit according to response rate, overall survival, progression free survival
Time Frame
4 years
Title
Post-treatment Axitinib target status assessment
Time Frame
4 years
Title
Safety essessment
Description
assessment of the safety profile of Axitinib in agreement with the incidence of related adverse events.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pat centrally confirmed diagnosis of solitary fibrous tumor
Expression of PDGFRB and/or VEGFR2 by immunohistochemistry on formalin fixed-paraffin embedded (FFPE) material as minimal requirement. Activation of PDGFRB and/or VEGFR2 by real time C reactive protein of PDGFB and VEGFA on FFPE material (if in sufficient quantity) or by biochemistry on frozen material (if available)
Locally advanced disease (i.e. surgical resection of local disease unfeasible radically, or unaccepted by the patient, or amenable to become less demolitive, or feasible, or easier, after cytoreduction) and/or metastatic disease
Measurable disease
Centrally confirmed evidence of progression by RECIST during the 6 months before study entry
1st-line vs 3-rd-line
Eastern Cooperative Oncology Group (ECOG) Performance Status = 0, 1, 2
Adequate bone marrow function, defined as the following: absolute neutrophil count (ANC) >1.5 x 109/L, platelets >100 x 109/L, Hb >9 g/dL. Blood transfusions are allowed to reach the baseline requested Hb level
Adequate organ function, defined as the following: total bilirubin within normal institutional limits (but in case of Gilbert's syndrome), aspartate aminotransferase (AST) and Serum Glutamic Pyruvic Transaminase (ALT) <2.5 x upper normal limit (UNL), creatinine <1.5 x upper normal limit (UNL), within normal institutional limits or creatinine clearance ≥60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
Cardiac ejection fraction ≥50% as measured by echocardiogram
Age > 18 yrs
Female patients of child-bearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug
No history of arterial and/or venous thromboembolic event within the previous 12 months
Written, voluntary informed consent
Exclusion Criteria:
Other primary malignancy with <5 years clinically assessed disease-free interval, except basal cell skin cancer, cervical carcinoma in situ, or other neoplasms judged to entail a low risk of relapse
Previous treatment with any other investigational or not investigational agents and or radiation therapy within 28 days of first day of study drug dosing, or patients who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Major surgery within 2 weeks prior to study entry
Previous radiotherapy to ≥25 % of the bone marrow
Concomitant other investigational agents or concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded
Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., history of uncontrolled or symptomatic angina, history of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation, myocardial infarction < 6 months from study entry, uncontrolled or symptomatic congestive heart failure, ejection fraction below the institutional normal limit)
Known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
Known diagnosis of human immunodeficiency virus (HIV) infection
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Axitinib
Expected non-compliance to medical regimens
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Stacchiotti, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Naazionale dei Tumori
City
Milan
State/Province
MI
ZIP/Postal Code
20133
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Phase II Study on Axitinib in Advanced Solitary Fibrous Tumor
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