Health Condition 1: null- Phase I -squamous cell carcinoma of head & neck Phase II -locally advanced squamous cell carcinoma of head & neck
Conditions
Interventions
Intervention1: P276-00: dose level 1: 100 mg/m2/day dose level 2:
140 mg/m2/day
dose level 3: 185 mg/m2/day
to be given from day 1 to day 5 every 21 days for 2 cycle.
Intervention2: External beam
Sponsors
Piramal Life Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Disease specifications: a. Phase I component: Radiation naïve subjects with histologically and/ or cytologically confirmed squamous cell carcinoma of head and neck that is non-metastatic, unresectable and recurrent. Radiation naïve subjects with non-recurrent, non-metastatic, unresectable, disease can also be enrolled if he/she is intolerant to and/or unwilling for chemoradiotherapy involving standard cytotoxic agents (e.g. cisplatin, carboplatin, oxaliplatin, 5-FU, taxanes, methotrexate, etc) b. Phase II component: Radiation naïve subjects with non-recurrent, non-metastatic, unresectable, locally advanced squamous cell carcinoma of head and neck who are intolerant to and/or unwilling for chemoradiotherapy involving standard cytotoxic agents (e.g. cisplatin, carboplatin, oxaliplatin, 5-FU, taxanes, methotrexate, etc). 2. Treatment specifications: a. Phase I Component: subjects must not have received any treatment (chemotherapy, targeted or biologic agents, radiotherapy, surgery etc) for the recurrent disease. b. Phase II Component: The subjects must not have been curatively operated for the disease. 3. Subjects must have completed any prior chemotherapy, biologic/targeted anti-cancer therapy or surgery at least 4 weeks (at least 6 weeks for nitrosureas and mitomycin C) before initiation of protocol treatment and subjects must have recovered (to grade < or =1) from the toxic effects from any prior therapy 4. Measurable disease as per RECIST criteria. 5. Age > or =18 years 6. ECOG (Eastern Cooperative Oncology Group) performance status < or = 2 7. Life expectancy of at least 12 weeks 8. Normal organ and marrow function as defined below: Hemoglobin > or = 100 g/L, Leukocytes >or =3 x 109/L, Absolute Neutrophil Count (ANC) > or = 1.5 x 109/L, Platelets > or =75 x 109/L, Total bilirubin < or=1.5 X institutional Upper Limit of Normal (ULN), AST(SGOT) < or = 2.5 X institutional ULN, ALT(SGPT)< or =2.5 X institutional ULN, Creatinine < or = 1.5 X institutional ULN
Exclusion criteria
Exclusion criteria: 1. Nasopharyngeal carcinoma 2. Any other investigational drug therapy within 1 month prior to day 1 of study drug administration or non-recovery (to grade less than equal to 1) from adverse effects of the investigational agent received prior to this period. 3. History of unstable angina or myocardial infarction or stroke within 6 months prior to initiation of protocol treatment. 4. QTcF more than 450 msec 5. Uncontrolled inter-current illness or any condition that would limit compliance with study requirements. 6. Subjects known to be suffering from infection with HIV, Tuberculosis, Hepatitis C or Hepatitis B. 7. Pregnancy or lactation. 8. Women of childbearing potential or men, not agreeing to use at least 2 approved methods of contraception (one of which being a barrier method) unless they are surgically sterilised.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) and dose limiting toxicity (ies) (DLT/s) of P276-00 in combination with radiation in subjects with recurrent and/or locally advanced squamous cell carcinoma of head and neck (SCCHN).Timepoint: At the end of study | — |
Secondary
| Measure | Time frame |
|---|---|
| To analyze pharmacokinetics (PK) of P276-00 in the study population.Timepoint: At the end of study;To evaluate efficacy of the combination regimen of P276-00 and radiation in the study populationTimepoint: At the end of study;To evaluate safety and tolerability of the combination regimen of P276-00 and radiation in the study population.Timepoint: At the end of study;To perform exploratory analysis of biomarkers associated with use of P276-00 and radiation in the study populationTimepoint: At the end of study | — |
Countries
India
Contacts
Public ContactDr Sanjeev Hegde
Outcome results
None listed