CTRI/2022/06/043203已完成2 期
A Phase 2a, multi-center, placebo-controlled, randomized, assessor-blind study to assess the safety & efficacy of parenteral TK-90 or parenteral TK-90 placebo administered daily to Patients scheduled to receive radiotherapy for non-metastatic squamous cell carcinoma of the head and neck (SCCHN). - TOSK 0004
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Tosk Inc
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Participants must meet all of the following criteria at the time of screening unless otherwise specified:
- •1. Patient must sign study specific informed consent prior to study entry.
- •2. Male or Female patient aged 18 â?? 75 years.
- •3. Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx.
- •4. Patients must have at least 1 mucosal site of the oral cavity/oropharynx/hypopharnyx mucosa assessable by visual transoral inspection that will receive cumulative radiation dose of 70 Gy.
- •Note: Unavoidable doses of at least 60 Gy, to include entrance, exit, and scatter doses, still constitutes planned radiation.
- •5. Patients with tumors of the larynx or hypopharynx are eligible only if it is anticipated that at least 1 index site in the oral cavity/oropharynx/hypopharnyx mucosa will receive cumulative radiation dose of 70 Gy.
- •6. Selected Stage I to III or IVA B per AJCC, Cancer Imaging Manual, 8th edition, at study entry, including no distant metastases other than non metastatic SCCHN, based upon the following minimum diagnostic workup:
- •i) History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to randomization.
- •ii) Chest CT scan within 8 weeks prior to randomization.
- •iii) MRI or CT scan with contrast of tumor site within 8 weeks prior to randomization
- •7. Mucositis Grade less than or equal to 1 per WHO Scale and Xerostomia of Grade less than or equal to 2 per CTCAE version 5.0
- •8. ECOG Performance Status less than or equal to 2.
- •9. Adequate bone marrow function as per CTCAE V5, defined as follows (within 2 weeks prior to randomization):
- •i) Absolute neutrophil count more than or equal to 1500cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization.
- •ii) Platelets more than or equal to 100,000 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to randomization.
- •iii) Hemoglobin more than or equal to 8.0 g/dl based upon CBC/differential obtained within 2 weeks prior to randomization (Note: The use of transfusion or other intervention to achieve Hgb more than 8.0 g/dl is acceptable).
- •10. Adequate hepatic function with bilirubin less than or equal to 1.5 x upper-normal limit (ULN), AST or ALT less than or equal 3 x ULN within 2 weeks prior to randomization.
- •11. Adequate renal function with serum creatinine less than 1.5 mg/dl and creatinine clearance (CrC) more than or equal 50 ml/min determined by 24 hour collection or estimated by Cockcroft Gault formula. CrC male is equal to [(140 - age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)]. CrC female is equal to 0.85 x (CrCl male) within 2 weeks prior to randomization.
- •12. Normal serum calcium or normal corrected serum calcium within 2 weeks prior to randomization formula for corrected calcium if albumin valued is below normal range Corrected calcium (mg/dl) is equal to (4 Patients albumin (g/dl) x 0.8) plus Patients measured calcium (mg/dl).
- •13. Negative serum pregnancy test for women of childbearing potential.
- •14. Women of childbearing potential and male participants with female partners of childbearing potential must practice adequate contraception.
排除标准
- •Patients who meet any of the following criteria at the time of screening will be excluded:
- •1. Stage IVC (Any T, Any N, M1) per AJCC Cancer Staging Manual. 8th ed, or distant metastases at protocol study entry other than metastatic SCCHN.
- •2. Prior invasive malignancy (except non melanomatous skin cancer) unless disease free for a minimum of 3 years.
- •3. Patients who have not fully recovered after prior surgery. (Patients who have had prior surgery and have fully recovered and patients who may have surgery in the future are eligible.).
- •4. Severe, active co-morbidity, defined as follows:
- •i) Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV.
- •ii) Transmural myocardial infarction within the last 6 months.
- •iii) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of screening.
- •iv) Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening.
- •v) Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
- •vi) Patients known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV).
- •5. Collagen vascular disease, such as scleroderma.
- •6. Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin, within 28 days of randomization.
- •7. Any prohibited therapy 2 weeks prior to randomization.
- •8. Pregnancy, breast feeding or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception.
- •9. Substance abuse, medical, psychological or social conditions that may interfere with the patients participation in the study or evaluation of the study results.
- •10. Known hypersensitivity study medication or excipients in the formulation.
- •11. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
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