Health Condition 1: D499- Neoplasm of unspecified behavior of unspecified site
Conditions
Interventions
Intervention1: LNP8701: 50 mg and 10 mg Tablets for
oral administration. LNP8701
will be administered orally in
once daily for 28 days for maximum of 6
cycles
Control Intervention1: Not Applicable: No
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female subjects =18 years of age. 2.Subjects must have a histologically or cytologically confirmed diagnosis of metastatic solid tumors. 3.Subjects with solid tumors must have at least one measurable tumor lesion according to response evaluation criteria in solid tumors (RECIST) v1.1. Subjects must have an ECOG performance status of 0 or 1. 4.Subjects must have clinical laboratory values that meet the following criteria: -Absolute neutrophil count =1.5 x 109/L -Platelets =100 x 109/L -Hemoglobin =9 g/dL -Serum bilirubin =1.5 x upper limit of normal (ULN) -Aspartate aminotransferase and alanine aminotransferase =3 x ULN in absence of liver metastases; or =5 x ULN if the subject has documented liver metastases 5.Subjects with history of disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumor type and disease stage, in the opinion of the investigator. 6.Subjects must have a life expectancy =12 weeks in the opinion of the Investigator.
Exclusion criteria
Exclusion criteria: 1. Subjects with symptomatic central nervous system (CNS) metastases. 2. History of another primary malignancy except for treated non-melanoma skin or cervical cancer in situ or ductal cancer in situ. 3. Evidence of clinically significant organ dysfunction. 4. Any major surgery, as determined by the investigator within 30 days of screening. 5. Positive screen test for HIV, Hepatitis B, Hepatitis C. 6. History of any relevant allergy/hypersensitivity to the study drugs or its excipient 7. Use of concomitant medication that might reasonably influence the results of the study prior to study drug administration and at any time during the study. 8. Received any therapy such as chemotherapy, radiotherapy, biologic therapy, immunotherapy, other investigational agent within 30 days or a washout of at least 5 half-lives whichever is long with respect to study drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine Maximum Tolerated Dose (MTD) of LNP8701Timepoint: From baseline till the end of cycle 1 at each dose level MTD will assessed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events (AEs) & serious AEs (SAEs) & PK parametersTimepoint: At the end of the treatment (approximately 24 weeks). | — |
Countries
India
Contacts
Public ContactDr Neelam Kardekar
Lupin Ltd.
Outcome results
None listed