Safety Issues
Conditions
Brief summary
Phase 1 open label dose ranging study of RH324 in advanced non-small cell lung cancer
Detailed description
This is a Phase 1 open label dose ranging study to assess the safety and tolerability of oral RH324 in advanced non-small cell lung cancer
Interventions
DRUGRH324
polymolecular
Sponsors
ReHeva Biosciences,Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Advanced Non-Small Cell Lung Cancer * Measurable Target Lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 * Failed all standard of care including chemotherapy, targeted therapy, and immunotherapy * Adults over 18 years * Performance status (Eastern Cooperative Oncology Group) less than or equal to 2 * Life expectancy greater than 2 months * Laboratory Values: Hemoglobin greater than or equal to 9; neutrophils greater than 1,000; platelets greater than 50,000 Liver function tests less than or equal to twice upper limit of normal Serum Creatinine less than or equal to 2 Creatinine clearance greater than or equal to 30 mL per minute Hemoglobin A1C less than 7 Normal Thyroid function * No history of hyperthyroidism * Abstinence from alcohol and supplements * Not pregnant, lactating and willing to use birth control throughout study * Able to provide consent * Positive Emission Tomography/Computer Tomography part of subjects care plan at baseline
Exclusion criteria
* Prior use of Withania somnifera * Phenylketonuria * Inability to swallow capsules * Hypersensitivity to study drug ingredients * Unstable medical or surgical condition * History of additional cardiac risk factors * Requiring drugs that are strong inhibitors of cytochrome P450 * Requiring irradiation * Requiring intravenous fluids or hyperalimentation * Requiring transfusions, dialysis, or other procedures * Active infection * Human Immunodeficiency Virus * Must exceed washout period of prior treatments * Psychiatric, neurological or other reason that precludes subjects ability to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events Per Common Terminology Criteria for Adverse Events Version 5 | Through Study Completion 28 Days | Percentage of Adverse Events Summarized by Causality and Grade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects with a Change from Baseline on Physical Examination and Vital Signs | Through Study Completion 28 Days | Percentage of Subjects with a Clinically Relevant Change from Baseline on Physical Exam and Vital Signs |
| Percentage of Subjects with a Change from Baseline on Laboratory Values | Through Study Completion 28 Days | Percentage of Subjects with a Clinically Relevant Change from Baseline on Blood and Urine Laboratory Values |
| Percentage of Subjects with a Change from Baseline on the Electrocardiogram | Through Study Completion 28 Days | Percentage of Subjects with a Clinically Relevant Change from Baseline on the 12-Lead Electrocardiogram |
| Percentage of Subjects with a Change from Baseline in Quality of Life | Through Study Completion 28 Days | Percentage of Subjects with a Clinically Relevant Change from Baseline in Quality of Life Based on the Eastern Cooperative Oncology Group Performance Status Levels |
Countries
United States
Contacts
Primary ContactCharles Packard
Outcome results
None listed