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AUR103 Calcium for Neuroendocrine Tumors

(BHARAT-3 Trial)

Not yet recruiting at 4 trial locations
AK
AS
Overseen ByAmanchi Swathi
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Aurigene Discovery Technologies Limited
Must be taking: Somatostatin analogues
Must not be taking: TKIs, mTOR inhibitors
Disqualifiers: Neuroendocrine carcinoma, MEN syndromes, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced, well or moderately differentiated neuroendocrine tumors that have gotten worse after at least one prior treatment. Participants must be in good physical condition and have measurable disease. They should have tried at least one FDA-approved therapy for their tumor type.

Inclusion Criteria

I have only received somatostatin analogues as treatment.
I am fully active or restricted in physically strenuous activity only.
I have an advanced, well or moderately differentiated neuroendocrine tumor.
See 14 more

Exclusion Criteria

I have a digestive issue that affects how my body absorbs calcium.
I have an active or long-term hepatitis B or C infection.
I have not taken any experimental drugs in the past 21 days.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

AUR103 calcium is administered twice daily until disease progression or intolerable toxicity

Up to 12 cycles (each cycle is 4 weeks)
Visits every cycle (4 weeks)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AUR103 Calcium

Trial Overview

The study tests AUR103 calcium, taken twice daily by itself, to see if it works and is safe for people with advanced neuroendocrine tumors who haven't responded to previous treatments. Treatment continues until the cancer worsens or side effects become too severe.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Phase 2 single agent study AUR103 calcium administered as 200 mg or 300 mg twice daily.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aurigene Discovery Technologies Limited

Lead Sponsor

Trials
10
Recruited
640+

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