CTRI/2023/08/056321
Recruiting
Phase 1
A Phase 1, Open Label, Dose Escalation, Dose Expansion, MulticenterStudy Evaluating the Safety, Pharmacokinetics and Pharmacodynamicsof Oral AUR108 in Patients with Relapsed Advanced Lymphomas(ASHA-1) - ASHA-1
Aurigene Oncology Limited(Subsidiary of Dr. Reddy’s Laboratories Limited)0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Aurigene Oncology Limited(Subsidiary of Dr. Reddy’s Laboratories Limited)
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Males or 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 \= 1000/µL (without WBC growth factor support)
- •b. Platelet count \= 75,000/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) \= 30 mL/min .
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.
- •2\. Presence of an acute or chronic toxicity resulting from prior anticancer 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\. Patients with cutaneous lymphomas, mycosis fungoides (MF) or Sézary syndrome (SS).
- •6\. Primary CNS lymphoma
- •7\. Known symptomatic or untreated or recently treated (\= 6 months of screening) central nervous system (CNS) lymphoma. Patients with previously treated ( \> 6 months of screening) CNS lymphoma and are now stable and asymptomatic, from CNS perspective, are allowed
- •8\. Patients with lymphoma that requires immediate cytoreductive therapy
- •9\. Patients with low\-grade lymphoma that does not meet conventional criteria for requiring treatment.
- •10\. Patients on the drugs which are sensitive substrates of CYP2C8 and cannot be discontinued at least one week prior to Cycle 1 Day 1\.
Outcomes
Primary Outcomes
Not specified
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