An Open-label, Dose-escalation, Phase I Clinical Trial to Evaluate the Tolerability and Safety of Standard Radiotherapy Combination with VS-101 in Subjects with Head and Neck Cancer

Not Applicable

Recruiting

Conditions: Neoplasms

Registration Number: KCT0007606

Lead Sponsor: VSPharm Tech

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 9

Inclusion Criteria

Select subject who meets the following criteria.
1. Male or female, = 19 years and <70 years of age at the time of obtaining consent
2. Pathologically (histologically or cytologically) diagnosed squamous cell carcinoma as subjects with head and neck cancer confirmed by imaging (CT or MRI or Laryngoscopy)
3. Subjects with head and neck cancer who have limited surgery and chemotherapy at the screening and who need standard radiation therapy.
1) T1 and T2 of the floor of the mouth
2) T1 and T2 of the base of tongue
3) T1 and T2 of the larynx (Hypopharynx)
4) T1 and T2 of the larynx (Larynx)
5) T1, T2 and exophytic T3 of the tonsilar region
6) Subjects who require standard radiotherapy with maximum 70 Gy/35 Fraction by the decision of investigator
4. ECOG performance status of 0 or 1
Table 1. ECOG Performance status
0 Fully active, able to carry on all pre-disease performance without restriction
1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2 Ambulatory and capable of all selfcare but unable to carry out any work activities: up and about more than 50% of waking hours
3 Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4 Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5 Dead
5. Subjects who have recovered to = grade 1 (under the NCI-CTCAE ver.5.0) all acute or chronic AE related to previous treatments at the screening.
6. Predicted Life expectancy of = 20 weeks
7. Subjects who can comply with all requirements in the protocol
8. Subjects who voluntarily sign a written informed consent

Exclusion Criteria

Subjects who satisfy the following criteria are excluded.
1. Medical history
1) Subjects who have suicide attempt, major depressive disorder, psychotic disease [bipolar disorder, ADHD (attention deficit hyperactivity disorder) etc.]
2) Subjects with neuroleptic malignant syndrome, tardive dyskinesia, elderly subjects with dementia related psychosis, uncontrolled hyperglycemia/diabetes mellitus, venous thromboembolism
3) Subjects with orthostatic hypotension [cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or ECG abnormalities), cerebrovascular disease or conditions which would predispose subjects to hypotension (dehydration, hypovolemia and treatment with antihypertensive medications)]
4) Subjects with a history of seizures/convulsions
5) Subjects who have possibility impairments in cognition and motor performance (somnolence and sedation) and subjects who are taking drugs that may be affected)
6) Subjects who will be experiencing conditions which may contribute to an elevation in core body temperature, (e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration)
7) Subjects who have dysphagia (taking a medication causing this potential, aspiration pneumonia, esophageal dysmotility)
8) Subjects with a history of clinically significant allergy (except for mild allergic rhinitis that does not require medication administration) or known hypersensitivity to other drugs (aspirin, antibiotics etc.)
2. Subjects who show abnormalities in the following test results in laboratory tests at the time of screening
1) ALT or AST > 2.5 x ULN
2) Total serum creatinine > 1.5 x UNL
3) ANC < 1,500/?
4) Platelets < 100,000/?
5) Hemoglobin (Hb) < 9 g/?
6) Serum calcium > 1.5 x ULN
7) Potassium or Magnesium > Normal range
8) PT (INR) > 1.5 x ULN or aPTT (Sec) > Normal range
9) Positive results for Serology test (HBV, HCV, HIV, Syphilis reagin test)
10) Clinically significant ECG abnormalities
3. Known hypersensitivity to the active ingredient or excipients of the investigational product
4. Subjects with a history of drug abuse (particularly, drugs that act on the central nervous system such as sleeping pills, centrally acting analgesics, opiates or antipsychotic drugs)
5. Prohibited medication and therapy
1) Subjects who have administered CYP3A4 or CYP2D6 inducers or inhibitors (e.g., carbamazepine, rifampin, ketoconazole, quinidine, fluoxetine, paroxetine, itraconazole, clarithromycin etc.) within 1 month prior to baseline
2) Subjects who received chemotherapy within 28 days prior to baseline *
* Medications or therapies known to have anticancer effects, such as cytotoxic agent, antihormonal agent and targeted agent
3) Subjects who have administered intravenous antibiotics, antiviral agent or antifungal agent within 14 days prior to baseline
4) Subjects who participated in other clinical research study as subjects and administered investigational product within 4 weeks prior to baseline
6. Subjects and spouse (or partner) who do not agree to use medically acceptable methods of contraception during the period study
1) Use of hormonal contraception, an intrauterine device with proven pregnancy fails rates [Intrauterine device (IUD), Intrauterine system (IUS)]
2) Use of barrier contraception (male cond