Health Condition 1: C189- Malignant neoplasm of colon, unspecified
Conditions
Interventions
Intervention1: AUR109 200 mg: Once a day, Oral Route, 28 days cycle, for at least 6 cycles
Control Intervention1: AUR 109 300 mg: Once a day, Oral Route, 28 days cycle, for at least 6 cycles
Sponsors
Aurigene Oncology Limited
Aurigene Oncology Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Provide signed and dated informed consent and agree to comply with all study related activities. 2) Male or female patients aged = 18 years. 3) Pathological diagnosis of adenocarcinoma of colorectal origin, epithelial ovarian cancer (ovarian cancer term also includes fallopian tube cancer as well as primary peritoneal cancer),or renal cell carcinoma of the kidney. 4) Patients must have received at least two lines of systemic therapy and should have exhausted all available local therapies.At a minimum,for each of the respective cancer types, patients should have received the following.
Exclusion criteria
Exclusion criteria: 1) Systemic anticancer therapy, such as chemotherapy, biological therapy, or Immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is longer, from the Cycle 1 Day 1of the study. 2) Pregnant or lactating women. 3) Any clinically significant medical, psychiatric, or social condition.or laboratory abnormality that may increase the risk of trialparticipation or may interfere with the informed consent process and or with compliance with the requirements of the trial or may interfere with the interpretation of the trial results and, in the Investigators opinion, would make the patient inappropriate forentry into this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy- To assess the efficacy of three dose levels of AUR 109 200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, and renal cancers, as measured by Objective Tumor Response Rate ORR CR + PR. To assess the safety and tolerability profile of the three dose levels of AUR 109 (200 mg, 300 mg, and 400 mg) in patients with colorectal, ovarian, and renal cancers.Timepoint: Baseline,Cycle 3,Cycle 6,Cycle 9, Cycle 12, Cycle 15. | — |
Secondary
| Measure | Time frame |
|---|---|
| B. SECONDARY ENDPOINTS Efficacy- To assess the efficacy of three dose levels of AUR 109 200 mg, 300 mg, and 400 mg in patients with colorectal, ovarian, and renal cancers as measured by: Duration of Response DoR. Clinical Benefit Rate CBR CR + PR + SD. Duration of CBR. Progression Free Survival. Overall Survival OS. Time to Progression TTP. Time to Objective Tumor Response TTR. To explore the pharmacodynamics PD effects of three dose levels of AUR 109 200 mg, 300 mg, and 400 mg on selected biomarkers in patients with colorectal, ovarian, and renal cancers. Timepoint: Baseline,Cycle 3,Cycle 6,Cycle 9, Cycle 12, Cycle 15. | — |
Countries
India
Contacts
Public ContactDr Akhil Kumar
Aurigene Oncology Limited (Subsidiary of Dr. Reddy’s Laboratories Limited)
Outcome results
None listed