AUR103 Calcium in Advanced Neuroendocrine Tumours (BHARAT-3 Study)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorAurigene Discovery Technologies Limited
About this trial
A phase 2 Study Evaluating the Efficacy and Safety of Single Agent AUR103 Calcium in Patients with Advanced, Well or Moderately differentiated Neuroendocrine Tumours.
This is a Proof of Concept (PoC) Phase 2 study of AUR103 calcium in patients with advanced, well or moderately differentiated neuroendocrine tumours.
The main objective is to evaluate the efficacy of AUR103 calcium in patients with well or moderately differentiated neuroendocrine tumors.
Patients with relapsed/refractory well or moderately differentiated neuroendocrine tumors.
AUR103 calcium will be administered twice daily. Patients will receive AUR103 calcium until disease progression or intolerable toxicity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years.
Eastern Coorperative Oncology Group (ECOG) Performance status of 0 or 1.
Pathologically confirmed, well or moderately differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumour.
Patients should have progressed after at least one line of therapy.
Disqualifiers
Neuroendocrine carcinoma, such as small cell carcinoma.
Grade 3 neuroendocrine tumours (NET) and/or Poorly differentiated NET.
Patients with known MEN-1 (Multiple Endocrine Neoplasia-1) or MEN-2 (Multiple Endocrine Neoplasia-2) syndromes.
Known impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral AUR103 calcium.
Trial design
Design model
Single group
Treatments tested in this trial
AUR103 Calcium
DrugAUR103 Calcium 200mg or 300mg administered twice daily
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Phase 2 single agent study AUR103 calcium administered as 200 mg or 300 mg twice daily.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate
Objective response rate (\[ORR\] = CR + PR) by RECISTv1.1.
Time frame
3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.Secondary outcomes
1
Efficacy: Time to response (TTR)
Time to respone (TTR) will be assessed during the study
Time frame
3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.2
Efficacy: Duration of Response (DOR)
Duration of Response (DOR) will be assessed during the study
Time frame
3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.3
Efficacy: Stable Disease (SD)
Sable Disease (SD) will be assessed during the study
Time frame
3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.4
Efficacy: Clinical Benefit Rate (CBR)
Duration of Clinical Benefit Rate (CBR) will be assessed during the study
Time frame
3rd week (Days 15-21) of Cycle 2, and thereafter every 2 cycles up till Cycle 6 (i.e., between Day 15-21 of Cycles 4, 6) and then every 3 cycles (i.e., towards the end of Cycle 9, 12). Each treatment cycle will be 28 days in length.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: