CTRI/2022/09/046061
Recruiting
Phase 1
A Phase 1, Open Label, Dose Escalation, Dose Expansion, Multicenter, First in Human (FIH) Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of Oral AUR105 in Patients with Relapsed Advanced Malignancies (SURYA-1) - SURYA-1
Aurigene Discovery Technologies Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Aurigene Discovery Technologies Limited
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<\= 1\.5 x ULN; (Patients with known Gilbertâ??s syndrome are allowed with a Total Bilirubin \<\= 2\.5 x ULN)
- •AST (SGOT) \<\= 3 x ULN (\<\= 5 Ã? ULN if known liver metastases)
- •ALT (SGPT) \<\= 3 x ULN (\<\= 5 Ã? ULN if known liver metastases)
- •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.)
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 \<\= 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)
- •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) central nervous system (CNS) metastases or CNS lymphoma. Patients with previously treated ( \> 6 months of screening) CNS metastases or CNS lymphoma and are now stable and asymptomatic from CNS perspective are allowed.
- •7\. Major surgery \<\= 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia)
Outcomes
Primary Outcomes
Not specified
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