A Phase 2 study of Sorafenib (BAY 43-9006) in patients with advanced salivary Adenoid Cystic Carcinoma

Phase 1

• Conditions: advanced salivary adenoid cystic carcinoma; MedDRA version: 9.1 Level: PT Classification code 10053231 Term: Adenoid cystic carcinoma; MedDRA version: 9.1 Level: LLT Classification code 10051975 Term: Salivary gland carcinoma

• Registration Number: EUCTR2008-000066-22-GB
• Lead Sponsor: Christie Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-29
• Study Completion: 2013-06-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Age > 18 years old
2) Histological diagnosis of adenoid cystic carcinoma of the head and neck which is locally recurrent and/or metastatic
3) Patients with at least one uni-dimensional measurable lesion. Lesions must be measured by CT-scan or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST, see Appendix 10.3)
4) Life expectancy of at least 12 weeks
6) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures
7) Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
8) Ability to understand the patient information sheet and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
9) ECOG performance status of 0 or 1.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) History of cardiac disease: congestive heart failure >NYHA (New York Heart Association) class 2; active CAD (Coronary artery disease) (Myocardial Infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted) or uncontrolled hypertension
2) Known history of HIV (Human immunodeficiency virus) infection or chronic hepatitis B or C
3) Active clinically serious infections (> grade 2 NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0)
4) Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
5) Known brain metastasis. Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis.
6) History of organ allograft
7) Patients taking prophylactic warfarinwho are unable to convert to low molecular weight heparin
8) Patients who are taking cortocosteroids and whose steroid therpay cannot be stopped
9) Patients with evidence or history of bleeding diathesis or coagulopathy
10) Patients undergoing renal dialysis
11) Cancer other than salivary adenoid cystic carcinoma within 5 years prior to start of study treatment EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors [Ta (Noninvasive tumor), Tis (Carcinoma in situ) & T1 (Tumor invades lamina propria)]
12) Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
13) Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months.
14) Pulmonary haemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
15) Any other haemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
16) Serious, non-healing wound, ulcer, or bone fracture.
17) Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must use adequate birth control measures (such as a male condom) during the course of the trial.
18) Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
19) Known or suspected allergy to the investigational agent or any agent given in association with this trial.
20) Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
21) Patients unable to swallow oral medications.
22) Any malabsorption condition
23) History of severe skin disease, including hand-foot syndrome

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified