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
Qualifiers
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
Treatments tested in this trial
- AUR103 Calcium
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov