CTRI/2023/05/052954
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 AUR107 in Patients with Relapsed Advanced Malignancies (SHAKTI-1) - SHAKTI-1
Aurigene Oncology Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
- Sponsor
- Aurigene Oncology Limited
- Status
- Recruiting
- Last Updated
- last year
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:
- •a.ANC \= 1500/µL (without WBC growth factor support).
- •b.Platelet count \= 100,000/µL without transfusion support.
- •c.Hemoglobin \= 9 g/dL (Transfusion is allowed to achieve this Hb).
- •d.Total Bilirubin \= 1\.5 x ULN; (Patients with known Gilbert’s syndrome are allowed with a Total Bilirubin \= 2\.5 x ULN).
- •e.AST (SGOT) \= 3 x ULN (\= 5 × ULN if known liver metastases).
- •f.ALT (SGPT) \= 3 x ULN (\= 5 × ULN if known liver metastases).
- •g.Creatinine clearance (CrCl) \= 60 mL/min (either measured or estimated by the Cockcroft\-Gault formula).
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).
- •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 (\= 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated ( \> 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed.
- •6\.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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