A clinical trial to study the Dose, Safety and tolerance of TK-112690 injection in Head and Neck cancer patients receiving radiation and chemotherapy
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2023/11/060212
- Lead Sponsor
- Tosk Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patient must sign study-specific Informed consent prior to study entry.
2. Male or Female patients aged 18 – 75 years.
3. Pathologically (histologically or cytologically) proven (from primary lesion and/or lymph nodes) diagnosis of squamous cell carcinoma of the oral cavity (Refer Definition in 10.13.1), 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 60-70 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 (Refer section 10.13.1) will receive cumulative radiation dose of 60-70 Gy.
6. Patients with Stage I to III or IVA-B as 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:
- History/physical examination, including documentation of tobacco/alcohol use and current medications (including opioids/dosing), within 8 weeks prior to enrollment.
- PET /CT Scan/MRI within 8 weeks of enrollment.
7. Mucositis Grade = 1 per WHO Scale and Xerostomia of Grade = 2 per CTCAE version 5.0.
8. ECOG Performance Status = 2.
9. Adequate bone marrow function as per CTCAE V 5, defined as follows (within 2 weeks prior to enrollment):
- Absolute neutrophil count = 1500 cells/mm3 based upon CBC/differential obtained within 2 weeks prior to enrollment.
- Platelets = 100,000 cells/mm3 based upon CBC obtained within 2 weeks prior to enrollment.
- Hemoglobin = 8.0 g/dl based upon CBC obtained within 2 weeks prior to randomization (Note: The use of transfusion or other intervention to achieve Hgb > 8.0 g/dl is acceptable).
10. Adequate hepatic function with bilirubin = 1.5 x upper-normal limit (ULN), AST or ALT
=3 x ULN within 2 weeks prior to enrollment.
11. Adequate renal function with serum creatinine < 1.5 mg/dl and creatinine clearance (CrC) = 50 ml/min determined by 24-hour collection or estimated by Cockcroft-Gault formula. CrC male equals [(140 - age) x (wt in kg)] / [(Serum Cr mg/dl) x (72)]. CrC female equals 0.85 x (CrCl male) within 2 weeks prior to enrollment.
12. Negative serum pregnancy test for women of childbearing potential.
13. Women of childbearing potential and male participants with female partners of childbearing potential must practice adequate contraception.
1. Stage IVC (Any T, Any N, M1) per AJCC Cancer Staging Manual. 8th ed, or distant metastases at protocol study entry.
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 to SCCHN surgery. (Except those 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:
-Symptomatic and/or uncontrolled cardiac disease, New York Heart Association Classification III or IV.
-Transmural myocardial infarction within the last 6 months.
-Acute bacterial or fungal infection requiring intravenous antibiotics at the time of screening.
-Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of screening.
-Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects.
-Patients known to be sero-positive for human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV).
5. Concurrent available or experimental systemic or topical pharmaceuticals or devices or low-level laser therapy for OM. Oral rinses—limited to sodium bicarbonate, lidocaine, and antifungal agents—will be permitted. Supportive care per ASCO guidelines is permitted and encouraged.
6. Collagen vascular disease, such as scleroderma.
7. Previous treatment with palifermin or other keratinocyte growth factors, such as velafermin or repifermin, within a month of enrollment.
8. Any prohibited therapy 2 weeks prior to enrollment. (see Section 8.4)
9. Pregnancy, breast feeding or women of childbearing potential and men who a sexually active and not willing/able to use medically acceptable forms of contraception.
10. Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
11. Known hypersensitivity study medication or excipients in the formulation.
12. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
13. The use of steroids during treatment.
14. Supportive care is allowed after approval of medical monitoring
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.DLTs- Any grade =3 DLTs during study graded according to the CTCAE, v5.0 that cannot clearly be attributed to a cause other than TK-112690. <br/ ><br>2.MTD. Highest dose administered that is not associated with a DLT if three patients are treated or two or more DLTs if 6 patients are treated. <br/ ><br>3.RP3D. Dose based on achieving a MTD or achieving a plasma concentration expected to be efficacious based on animal experiments with TK-112690. <br/ ><br>4.Incidence of radiation induced mucositis (RIM).Timepoint: 7 weeks
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI