Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Conditions
Interventions
Intervention1: AUR107: 5 mg, 10 mg, 20 mg, 40 mg, 60 mg, 90 mg, 135 mg, and 200mg orally Once Daily.
Duration of the study is 4 years
Control Intervention1: Nil: Nil
Sponsors
Aurigene Oncology Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and females â?¥ 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: a. ANC â?¥ 1500/μL (without WBC growth factor support). b. Platelet count â?¥ 100,000/μL without transfusion support. c. Hemoglobin â?¥ 9 g/dL (Transfusion is allowed to achieve this Hb). d. Total Bilirubin â?¤ 1.5 x ULN; (Patients with known Gilbertâ??s syndrome are allowed with a Total Bilirubin â?¤ 2.5 x ULN). e. AST (SGOT) â?¤ 3 x ULN (â?¤ 5 Ã? ULN if known liver metastases). f. ALT (SGPT) â?¤ 3 x ULN (â?¤ 5 Ã? ULN if known liver metastases). g. Creatinine clearance (CrCl) â?¥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). 4. Ability to swallow and retain oral medications. 5. Histo-pathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening. 6. Evidence of measurable disease per RECIST, v1.1 for solid tumors (Eisenhauer et al. 2009). 7. Standard curative measures do not exist, and patient must have exhausted all effective therapies, available locally. Notes: 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. 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 lesser than equal to 1, as determined by NCI CTCAE v 5.0. 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). â?¢ Use of any investigational agent within 28 days or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1. 4. Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1 (The list of these medications is provided in specific rows within Table 5). Note: This class of drugs are also prohibited during DLT evaluation period and must be either avoided or used with caution beyond DLT evaluation period. 5. Known symptomatic or untreated or recently treated (lesser than equal to 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (greater than 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed. 6. Major surgery lesser than equal to 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia). 7. Patients with leukemia, myelodysplastic syndrome, lymphoma, plasma cell leukemia, smoldering multiple myeloma, Waldenstrom s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis. 8. Active infection requiring systemic therapy. Note: 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. 9. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness. 10. Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve). 11. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study. 12. 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. 13. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in past 3 months, before Cycle 1 Day 1. 14. QTc (Bazzett) interval greater than 460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose. <br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ First cycle Dose Limiting Toxicities (DLT) â?¢ Safety and tolerability of AUR107 as measured by NCI CTCAE v 5.0 â?¢ Optimal Biological Dose (OBD) â?¢ PK parameters including but not limited to Cmax, Cmin, Tmax, AUC0-t, AUC0-last, MRT and t½ â?¢ Comparison of PK parameters in fasting and fed conditions Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ PD biomarkers â?¢ 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) â?¢ Change in Tumor Specific Markers like PSA in Castrate Resistant Prostate Cancer, CA-125 in ovarian cancer, CEA in colorectal cancer Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactOduru Suresh Reddy
Aurigene Oncology Limited (Subsidiary of Dr. Reddyâ??s Laboratories Limited)
Outcome results
None listed