Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
Conditions
Interventions
Intervention1: JBI-778 Oral Capsule
40 mg daily dose in 21-day continuous cycles
Once daily dosing in repeated 21-day cycles. JBI-778
capsule is taken orally with water approximately same time
either
Sponsors
Jubilant Therapeutics India Limited
Eligibility
Inclusion criteria
Inclusion criteria: Males or females aged >= 18 years at the time of informed consent. Screening laboratory values: Absolute neutrophil count (ANC) >=1,500 cells/mm3. Platelet count >=100,000 cells/mm3. Total bilirubin syndrome may be enrolled with up to 3.0Ã?ULN. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ULN (unless liver metastases are present then up to Creatinine clearance (CrCL) >= 40 mL/min based on the Cockcroft-Gault glomerular filtration rate estimation or other equally relevant calculations. (Refer in Appendix VIII) Prothrombin Time (PT) or Activated Partial Thromboplastin Time (aPTT) ULN if the patient is not on anticoagulants (If the patient is on anticoagulants, the patient must be on a stable dose for at least 2-weeks prior to screening).
Exclusion criteria
Exclusion criteria: Treatment with systemic anticancer therapy or an investigational agent within 2-weeks or 5 half-lives, whichever is shorter, prior to the start of study drug treatment. Major surgery effects of such procedure. Surgery (e.g., stomach bypass) or medical condition that might significantly affect the absorption of medicines (as judged by the investigator). Radiotherapy within 4 week for brain metastases and 2-weeks for the rest of body part prior to the start of study drug treatment. Patients must have recovered from all radiotherapy-related toxicities prior to the start of study treatment. Severe or unstable medical condition, such as congestive heart failure (New York Heart Association [NYHA] Class III or IV), ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication (>= Grade 2, according to NCI CTCAE V5), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness. Note: stable chronic atrial fibrillation is allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint Incidence of dose-limiting toxicity (DLT)events during the DLT monitoring period.[Timeframe: Baseline through Day 21 of Cycle1]. Timepoint: [Timeframe: at 6 months and up to approximately 2 years] | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Incidence of adverse events (AE) characterized overall and by type, frequency,seriousness, relationship to study treatment,timing, and severity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. â?¢ Changes in clinical laboratory parameters, vital signs, electrocardiogram (ECG) parameters, eye examination including slit lamp examination and physical examination.Timepoint: [Timeframe: up to approximately 2 years];PK profile as assessed by single-dose and steady-state such as Cmax, tmax, AUC0-t, AUCÏ?, AUC0-â??, and t½ etc. â?¢ To assess exposure/QTc relationshipTimepoint: [Timeframe: up to approximately 2 years];â?¢ Change from baseline in symmetrical dimethylarginine (SDMA) as a PD measure. Timepoint: [Timeframe: up to approximately 2 years];IDH Mutated WHO Grade 3/4 Recurrent Glioma â?¢ Response rate by response assessment in neuro-oncology (RANO) â?¢ Progression free survival (median and landmark) by RANO Overall survival â?¢ Neurological assessment in neuro-oncology (NANO)Timepoint: [Timeframe: up to approximately 2 years];Metastatic or advanced, incurable disease arising from any primary site Progression free survival by RECIST 1.1 â?¢ Investigator-assessed overall response rate (ORR) and duration of response (DOR) as defined by response evaluation criteria (RECIST) Version 1.1. â?¢ Overall survival Timepoint: [Timeframe: at 6 months and up to approximately 2 years];Brain Metastases and extracerebral disease â?¢ Response rate by response assessment in neuro-oncology brain metastases (RANO). â?¢ Progression Free Survival for cerebral and extracerebral disease by RANO and RECIST 1.1 respectively. â?¢ Investigator-assessed ORR and DOR as defined by response evaluation criteria in solid tumors (RECIST) Version 1.1 for extracerebral disease. â?¢ Overall survival â?¢ Neurologic assessment in neuro-oncology (NANO) Timepoint: [Timeframe: up to approxima | — |
Countries
India
Contacts
Public ContactShawnavaz Vazeer
Jubilant Therapeutics India Limited
Outcome results
None listed