Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Conditions
Sponsors
Nisarga Biotech Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with histologically confirmed, locally advanced and/or metastatic OSCC who are candidate for palliative chemotherapy or palliative radiotherapy as approved by the investigator. 2.Patients with adequate organ system function. 3.ECOG performance status of 0-2. 4.Life expectancy of at least 12 weeks. 5.Males and females >= 18 years of age. 6.Ability to swallow and retain oral medication. 7.Women of child-bearing potential with a negative serum pregnancy test. 8.Male should consent to use effective method of contraception and abstain from donating sperm, throughout the study period and for 12 weeks after the last dose of study drug. 9. Willingness and ability to comply with trial and follow-up procedures. 10. Ability to understand the nature of this trial and give written informed consent.
Exclusion criteria
Exclusion criteria: 1.Other cancer therapy such as immunotherapy or biologic therapy in the last 3 weeks or the last 5 T½ of the agent, whichever is shorter. 2.Patient has severe (Grade 3) adverse event of any previous cancer therapy. 3.Use of any investigational drug in the last 3 weeks or 5 T½ (whichever is shorter) prior to the first dose of study drug. 4. Known history of severe liver injury that includes drug-induced liver injury, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension. 5.Any severe and/or uncontrolled medical conditions or other conditions that in the opinion of Principal Investigator could affect their participation in the study. 6.Patient on any other alternative medications (ayurvedic, homeopathy or unani medicine). (There preparations/ medications should be discontinued 48 hours prior to first dose of study drug). 7.Presence of other active cancers at the time of enrollment. 8.Women who are pregnant or lactating. 9.Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 10.Concurrent condition that in the investigatorâ??s opinion would jeopardize compliance with the protocol. 11.Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Quality of life (measured using FACT-G questionnaire) from baseline till End of treatment (EOT) Timepoint: Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in levels of immune markers (e.g. IFN-γ, IFN-β, TNF-α, IL-6, IL-1 and NF-kβ) from Day1 to EOT (Day 84). 2. Incidence of adverse events (AEs) with Onconeem administered along with SOC. 3. Incidence of cancer chemotherapy induced nausea and vomiting using Visual Analogue Scale (VAS) 4. Incidence of viral infection (herpes zoster).Timepoint: Day 84 | — |
Countries
India
Contacts
Public ContactGirish Soman
Med Indite Communications Pvt Ltd
Outcome results
None listed