Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: AXL1717 capsule: Single dose, Oral, one AXL1717 capsule containing 25 mg and 50 mg of AXL1717 with 7 days of follow-up for safety.
Control Intervention1: NIL: NIL
Sponsors
Cadila Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male/female Patients above the age of 18 years with Histologic or cytologic diagnosis of a solid tumor (preferably NSCLC - squamous or non-squamous) except cancers of the intestinal tract (gastric, colon, rectal, and pancreatic cancer). 2.Patients must have advanced disease and deemed refractory to standard anti-cancer therapy or are not expected to benefit or prolong survival from any standard anti-cancer therapy. 3.Royal Marsden Hospital score of ( 4.ECOG performance status 5.Patients have adequate bone marrow, kidney, liver, heart and lung function without clinical significant laboratory parameters as per below criteria: Hb >= 9.0 g/dL; Leukocyte count (>= 3.0 X 109/L), Neutrophil count (>= 1.5 X 109/L), Platelet count (>= 75 X 109/L), Total bilirubin (>= 1.5 times the upper institutional limit of the normal range), Liver transaminases (P-AST or P-ALT Alkaline phosphatase Plasma creatinine ( 12-lead ECG with normal tracings. 6.Fully recovered from any previous surgery (at least 4 weeks since major surgery). 7.Fully recovered from previous radiation therapy (at least 4 weeks). 8.Use of reliable forms of contraception in women of childbearing potential must [i.e., abstinence, spermicides, condoms, or other reliable forms of contraception other than oral contraceptives]. 9.All subjects must agree to practice approved methods of birth control (if applicable). A negative pregnancy test must be documented during the screening period for women of childbearing potential. 10.Patient capable of providing informed consent and compliance to follow study related procedure.
Exclusion criteria
Exclusion criteria: 1.Concurrent cancer chemotherapy, biologic therapy or radiotherapy. 2.No prior anti-cancer therapies within 4 weeks and recovered from toxicities due to prior anti-cancer therapy, 3.Use of potent inhibitors of CYP2C9 from 3 weeks to first administration of IP. 4.Concurrent treatment with CYP3A4 inhibitors. 5.Administration of any investigational agent within 28 days prior to current therapy. 6.Brain or leptomeningeal metastases, Tumors invading or abutting major blood vessels. 7. >=grade 2 diarrhoea or constipation within 14 days, bowel obstruction or motility disorders which influence drug absorption. 8.Concomitant severe or uncontrolled underlying medical disease unrelated to the tumour, psychiatric disorder. 9.Positive serology for HIV or active, known hepatitis B or C, HCV & HBsAg. 10.Unstable systemic disease (including active infection, uncontrolled HT, unstable angina, CHF, MI, cardiac arrhythmia, hepatic, renal or metabolic disease). 11.Female: pregnant, nursing an infant or planning pregnancy throughout the study, women of childbearing potential must use reliable forms of contraception. 12.Any condition in opinion of investigator may put patient at significant risk, confound results or interfere significantly with participation. 13.Participation in clinical study within 30 days prior to entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the maximum tolerated dose (MTD) of AXL1717. Identify starting dose for multiple dose study.Timepoint: End of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the safety and tolerability profile of AXL1717. Assessment of pharmacokinetic (PK) profile of AXL1717, including fasting and fed single oral dose.Timepoint: End of the study. | — |
Countries
India
Contacts
Public ContactDr Anil Avhad
Cadila Pharmaceuticals Limited
Outcome results
None listed