Activity of sorafenib in schwannomas

Phase 4

Completed

• Conditions: Cancer; Brain and Nervous System Tumour; Acoustic nerve

• Registration Number: ISRCTN49989464
• Lead Sponsor: Plymouth Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-14
• Study Completion: 2015-12-31
• Last Update Posted: 30 May 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Written informed consent
2. Diagnosis of NF2
3. Over 18 years in age
4. Presence of more at least two cutaneous schwannomas >1cm3 in area and accessible for biopsy
5. WHO/ECOG Performance Status 0 or 1
6. Adequate bone marrow function within 28 days prior to the baseline visit and:
6.1. WBC > 3.4x109/l
6.2. Platelets > 99x109/l
7. Adequate renal function within 28 days prior to the baseline visit
7.1. creatinine < 2.5 x upper limit of normal
8. Adequate hepatic function within 28 days prior to the baseline visit
8.1. LFT < 1.5 x upper limit of normal
8.2. Serum amylase < 1.5 x upper limit of normal
8.3. Prothrombin (PT) or INR (International Normalized Ratio) and Prothrombin Time (PTT) < 1.5 x upper limit of normal
8.3.1. Able to swallow tablets
9.3.2. Ppatients with the potential for pregnancy or impregnating their partner must agree to use acceptable methods of birth control to avoid conception
8.4. Female patients who are not using hormonal contraception must agree to employ two barrier methods of contraception (e.g. condom, diaphragm with spermicidal jelly) during the study and for 3 months following the end of their study participation
8.5. Female patients who are using hormonal contraception must agree to use an additional barrier method (e.g. condom or diaphragm with spermicidal jelly) during the study and for 3 months following the end of study participation
8.6. Post menopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential.
9. Women of childbearing potential with a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit
10. Male and female
11. Lower Age Limit 18 years

Exclusion Criteria

1. Hypersensitivity to sorafenib or any of its excipients
2. Cardiac arrhythmias requiring antiarrhythmics (betablockers and digoxin are allowed)
3. Symptomatic coronary artery disease or ischemia
4. Myocardial infarction (MI) within the last six months; congestive cardiac failure > NYHA Class II
5. Active clinically serious bacterial or fungal infections
6. Known history of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
7. Pregnant or breastfeeding
8. Patients with uncontrolled hypertension
9. Serious uncontrolled concomitant medical or psychiatric illness
9.1. Concomitant medications which have adverse interactions with sorafenib: rifampicin, ritonavir, ketoconazole, itraconazole and St John?s Wort
10. Treatment with strong CYP3A4 inhibitors (e.g., erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) which has not been discontinued or switched to a different medication at least 2
weeks prior to starting the study drug.
11. Treatment with strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbitol, St John?s Wort), which has not been discontinued or switched to a different medication at least 2 weeks prior to starting the study drug.
12. Grade 3 or higher impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome)
13. History of acute pancreatitis within one year of study entry or medical history of chronic pancreatitis
14. History of another primary malignancy that is currently clinically significant or currently requires active intervention.
15. Any other clinically significant medical or surgical condition which, according to the CI/PI?s discretion, should preclude participation
16. History of significant congenital or acquired bleeding disorder
17. Patients taking warfarin or cytotoxic drugs

Study & Design

• Study Type: Interventional
• Study Design: Not specified