First in Human Multicenter Open Name Dose-increase,Consolidation method to Study Safety drug-level in Blood & drug metabolism Clinical Activity of Oral JBI-778 in Lung Cancer Patients with, without Brain Metastasis IDH Mutated WHO Grade 3,4 Recurrent Glioma, Salivary glands tumor
- Conditions
- Health Condition 1: C399- Malignant neoplasm of lower respiratory tract, part unspecified
- Registration Number
- CTRI/2024/07/070802
- Lead Sponsor
- Jubilant Therapeutics India Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 =1.5× ULN (upper limit of normal). Patients with Gilbert’s
syndrome may be enrolled with up to 3.0×ULN.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5×
ULN (unless liver metastases are present then up to =5×ULN is allowed).
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) =1.5×
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).
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 = 21 days prior to starting study drug or has not recovered from adverse
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method