advanced HNSCC
Conditions
Interventions
Product Name: AT-101
Pharmaceutical Form: Tablet
INN or Proposed INN: (-)-Gossypol (G-)
Current Sponsor code: AT-101
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven squamous cell carcinoma of the head and neck • Oral cavity, oropharyngeal, or hypopharyngeal carcinoma • Inoperable TNM stage III/IV, M0 • Patient must have measurable disease • age > 18 years • performance status WHO 0-2 (see Appendix B) • No prior radiation therapy to head and neck region • No prior cisplatin-based chemotherapy • Adequate laboratory results: o WBC > 4.0 o platelets > 100,000 o calculated or 24 hour creatinine clearance > 50 ml/min o ASAT/ALAT =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel are excluded. Subjects with ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are also excluded. • Patients with Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification (see Appendix C) are excluded. • Patients with known active symptomatic fungal, bacterial and/or viral infection including active HIV are excluded. Note: protocol does not require screening for viruses; however, patients with known active infections are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to assess the feasibility, tolerability and the maximum tolerated dose (MTD) of oral AT-101 in combination with concurrent cisplatin-based chemotherapy and radiotherapy (RT) in advanced HNSCC, as a guidance for the recommended dose in future studies.;Secondary Objective: Additional objectives include the exploration of mechanisms, involved in the therapeutic effect of the different modalities in this combined modality treatment, exploration of pharmacokinetics of AT-101, and documentation of therapeutic effects.;Primary end point(s): • Tolerability of combined treatment consisting of oral AT-101 and concurrent cisplatin-based chemoradiation, i.e. the definition of a feasible, safely administrable daily dose of oral AT-101, close to the MTD, in combination with standard chemoradiation. | — |
Countries
Netherlands
Outcome results
None listed