Glioma treated with AZD4547
- Conditions
- Recurrent grade III or IV glioma with FGFR3-TACC3 or FGFR1-TACC1 fusion positive by RT-PCRMedDRA version: 18.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-005428-81-FR
- Lead Sponsor
- ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 38
Recurrent grade III or IV glioma with FGFR3-TACC3 or FGFR1-TACC1 fusion positive by RT-PCR
Recurrence occurring more than three months from the end of the radiotherapy or occurring outside the irradiated volume
Age 18 years
WHO 0-2 (KPS>50)
Adequate biological parameters: blood count, renal function, liver function, calcium, phosphate
Use of effective means of contraception (men and women) in subjects of child-bearing potential or evidence of post-menopausal status
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 28
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Pregnancy or breast-feeding women
Congestive heart failure, long QT or risk factors for long QT, important abnormalities in rhythm and heart conduction
History of myocardial infarction, unstable angina, stroke or transient ischemic attack within the last 6 months
Major surgical procedure (excluding placement of vascular access) within 2 weeks prior to study enrolment
As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required
Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of AZD4547
Previous history of retinal pigmented epithelial detachment RPED, previous laser treatment or intra-ocular injection for macular degeneration previous history of retinal vein occlusion (RVO) and retinal degenerative disease or any relevant other clinically relevant chorioretinal defect
Any investigational agents or study drugs from a previous clinical study within 30 days before the first dose of study treatment
Any chemotherapy, anticancer immunotherapy or anticancer agents within 4 weeks (6 weeks for nitrosourea) before the first dose of study treatment,
Potent inhibitors or inducers of CYP3A4 or 2D6 or substrates of CYP3A4 within the required washout period
Prior exposure to AZD4547 or any other anti-FGFR drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method