Health Condition 1: C768- Malignant neoplasm of other specified ill-defined sites
Conditions
Interventions
Intervention1: AUR-105: Once a day
Intervention2: AUR-105: 50 and 100mg orally Once Daily entire duration of the study
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Aurigene Discovery Technologies Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females >= 18 years of age . 2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. 3. Acceptable bone marrow and organ function at screening as described below: ANC >= 1500/μL (without WBC growth factor support) Platelet count >= 100,000/μL without transfusion support (Patients with lymphoma are allowed with Platelet count >= 75,000 / μL) Hemoglobin >= 9 g/dL (Transfusion is allowed to achieve this Hb) Total Bilirubin AST (SGOT) ALT (SGPT) Creatinine clearance (CrCl) greater than equal to 60 mL/min (either measured or estimated by the Cockcroft Gault formula). (Cockcroft Gault formula for estimated creatinine clearance (eCrCl) : eCrCl (140â?? Age)xWeight (kg)x(0.85 if Female)/ (72xserum creatinine mg/dL.) 4. Ability to swallow and retain oral medications 5. Histo pathological diagnosis of a solid tumor, Non Hodgkin lymphoma or Hodgkin Lymphoma Note: The solid tumors must be in Stage IV at screening. The lymphoma could be either in Stage III or IV according to Lugano classification (Cheson et al. 2014) at screening. Evidence of measurable disease per RECIST v1.1 for solid tumors (Eisenhauer et al. 2009) and per Lugano Criteria for Lymphoma (Cheson et al. 2014). 7. Standard curative measures do not exist and patient must have exhausted all effective therapies available locally. 7a. At a minimum solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer). 7b. At a minimum lymphoma patients must have received at least 2 prior lines of systemic therapies. These systemic therapies could be either in the stage II , III or IV. (Note: Any cancer patient with access to any effective therapy must not be enrolled)
Exclusion criteria
Exclusion criteria: 1. Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1 of the study. Note: Concomitant use of low dose prednisone (up to 10 mg/day) or medroxyprogesterone is allowed. Note: Patients with CRPC (castrate resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogues and such patients are allowed. 2. Presence of an acute or chronic toxicity resulting from prior anti cancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade 3. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial) 4. Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1 5. Use of moderate / strong CYP3A4 inhibitors/inducers or moderate / strong P-gp inhibitor/inducers within 2 weeks or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1 6. Known symptomatic or untreated or recently treated ( 6 months of screening) CNS metastases or CNS lymphoma and are now stable and asymptomatic from CNS perspective are allowed. 7. Major surgery 8. Patients with leukemia or myelodysplastic syndrome or multiple myeloma 9. Active infection requiring systemic therapy. Prophylactic use of antibiotics is allowed. Any infection detected during screening period which is resolved adequately according to investigator before the Cycle 1 Day 1 is allowed. 10. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome related illness 11 Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve) 12.The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study. 13.Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1 14. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months before Cycle 1 Day 1 15. QTc (Bazzett) interval >450 ms for male patients or >460 ms for female patients on ECG at screening and/or at Cycle 1 Day 1 pre-dose 16.Uncontrolled intercurrent illness including but not limited to symptomatic congestive heart failure uncontrolled hypertension unstable angina pectoris cardiac arrhythmia active peptic ulcer disease or significant gastritis active bleeding diatheses presence of any major medical illness eg renal hepatic hematologic gastrointestinal endocrine pulmonary or psychiatric illness social situations or clinically significant laboratory ECG abnormalities at screening any or a combination of illnesses which in the opinion of the PI may either put the patient at risk because of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoints First cycle DLT Safety and tolerability of AUR105 as measured by NCI CTCAE v 5.0 Recommended Phase 2 Dose (RP2D) PK parameters including but not limited to Cmax, Cmin, Tmax, AUC0-t, AUC0-last, MRT and t½ Comparison of PK parameters in fasting and fed conditions Timepoint: During first 28 Days (Cycle 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Exploratory Endpoints: PD biomarkers Efficacy assessments overall response rates, duration of response, PFS etc. as measured by RECIST 1.1 response criteria for solid tumor (Eisenhauer et al. 2009), Lugano Criteria for Lymphoma (Cheson et al. 2014) Change in Tumor Specific Markers like PSA in Castrate Resistant Prostate Cancer, CA-125 in ovarian cancer, CEA in colorectal cancer Timepoint: 43 Days | — |
Countries
India
Contacts
Public ContactOduru Suresh Reddy
Aurigene Discovery Technologies limited
Outcome results
None listed