A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of AUR 109 in Patients With Colorectal, Ovarian, and Renal Cancers
NCT06760702 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2026-04-17
Summary
This is an open-label, multicentre, randomized, Phase II study and will be conducted with co-primary objectives of the study are to assess the efficacy of AUR109, as measured by ORR and safety / tolerability at three different dose levels of the study drug in three cancer indications i.e., colorectal, ovarian cancer and renal cancer.
Conditions
- Ovarian Cancer
- Colorectal Cancer
- Renal Cancer
Interventions
- DRUG
-
AUR109 200mg
AUR109 200mg (once daily)
- DRUG
-
AUR109 300mg
AUR109 300mg once daily
- DRUG
-
AUR109 400mg
AUR109 400mg once daily
Sponsors & Collaborators
-
Aurigene Discovery Technologies Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-11-09
- Primary Completion
- 2026-02-01
- Completion
- 2026-02-01
- FDA Drug
- Yes
Countries
- India
Study Locations
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