Health Condition 1: null- Histologically and clinically confirmed oral leukoplakia Health Condition 2: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue
Conditions
Interventions
Intervention1: Apaziquone: Apaziquone is a novel, fully synthetic bioreductive alkylating indoloquinone. Apaziquone is enzymatically
reduced to generate cytotoxic species. It is a pro-drug that genera
Sponsors
Spectrum Pharmaceuticals Inc
Spectrum Oncology Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients, aged 18 years or older, with histologically and clinically confirmed oral leukoplakia
Exclusion criteria
Exclusion criteria: 1. Patient has presence of obvious head and neck or digestive tract cancer, carcinoma in situ (CIS), or previously treated head and neck cancer within the past 2 years 2. Patients with cases of carcinoma in situ, invasive squamous cell carcinoma, and lesions identified as inflammatory in nature (e.g. lichen planus) on biopsy 3. Patient has a contraindication to biopsy 4. Patient will need concurrent chemotherapy, radiotherapy, hormonal (other than Hormone Replacement Therapy for menopause), or immunotherapy during the time of study 5. Patient has used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study 6. Patient has had previous exposure to Apaziquone 7. Patient has a history of allergy to red color food dye 8. Patient is pregnant or breast-feeding 9. Patient has participated in another clinical trial in the past 6 months 10. Patient has received systemic steroids or topical oral steroid preparations in the past 3 months 11. Patient has a medical condition which in opinion of the investigator makes him not eligible to participate in the clinical study 12. Patient should not be receiving any other concomitant medication besides Apaziquone 13. Patient has received prior retinoid or other beta carotene therapy, including > 25,000 IU of vitamin A for any reason in the past 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 To determine the maximum tolerated dose (MTD) of Topical Apaziquone in patients with dysplastic oral leukoplakia. Part 2 Percentage of patients with complete/partial response to topical Apaziquone in patients with dysplastic oral leukoplakia.Timepoint: Each patient will be assessed at End of Treatment (EOT) Visit on Day 15 and End of Study (EOS) Visit conducted 30 days after administration of last dose of study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| The change in the histopathological grading of oral dysplastic lesions from baseline to EOS visit.Timepoint: Each patient will be assessed at End of Treatment (EOT) Visit on Day 15 and End of Study (EOS) Visit conducted 30 days after administration of last dose of study drug. | — |
Countries
India
Contacts
Public ContactDr Gaurav Kadam
Spectrum Oncology Pvt Ltd
Outcome results
None listed