A Phase 2 Study Evaluating the Efficacy and Safety Agent AUR103 Calcium in Patients With Advanced, Well or Moderately Differentiated Neuroendocrine Tumours (BHARAT-3)
Aurigene Discovery Technologies Limited
Summary
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
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 18 years. 2. Eastern Coorperative Oncology Group (ECOG) Performance status of 0 or 1. 3. Pathologically confirmed, well or moderately differentiated (G1 or G2), advanced (unresectable or metastatic), neuroendocrine tumour. 4. Patients should have progressed after at least one line of therapy. Notes: 1. All previous treatments are allowed 2. There is no upper limit on the number of prior lines of therapy. 3. Patient should have received at least one FDA approved therapy for his/her disease (i.e., Patient should have received at least one of everolimus,…