A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics (NCT05607199) | Clinical Trial Compass
TerminatedPhase 1
A First in Human Study of AUR 103 Calcium to Evaluate Safety, Pharmacokinetics and Pharmacodynamics
Stopped: Patient recruitment problems.
India27 participantsStarted 2022-09-16
Plain-language summary
A Phase I, Open Label, Dose-Escalation, First in Human (FIH) study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in patients with relapsed advanced malignancies (BHARAT-1).
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provide signed and dated informed consent and agree to comply with all study related activities.
. Male or female patients aged ≥ 18 years.
. Patients have to meet the following criteria for each of the respective parts of the study:
. Eastern Cooperative Oncology Group (ECOG) (Appendix D) Performance status of 0 or 1 (Patients with disease related ECOG 2 are allowed, in addition to ECOG 0 and 1).
. Acceptable bone marrow as described below:
. Acceptable organ function as described below:
. Ability to swallow and retain oral medications.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Negative serum pregnancy test in women of childbearing potential (WOCBP).
Exclusion criteria
. Systemic anti-cancer therapy, such as chemotherapy, or biological therapy, immunomodulatory drug therapy, received within the past 28 days or 5 half-lives, whichever is shorter, from the Cycle 1 Day 1 of the study. Concomitant use of prednisone or medroxyprogesterone is allowed. In Part 1, Patients with CRPC (castrate resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogues, and such patients are allowed.
. Acute promyelocytic leukemia (AML M3 subtype).
. Patients eligible for intensive chemotherapy for AML (such as the 3 + 7 regimen).
. CML in blast crisis (i.e., patients with known bcr-abl positive disease).
. Presence of an acute or chronic toxicity resulting from prior anti cancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade Less than 1, as determined by NCI CTCAE v 5.0 (Appendix G).
. Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited field palliative radiation is allowed and no restrictions during the screening period or during the trial).
. Use of any investigational agent within 28 days or 5 half-lives (whichever is shorter) prior to Cycle 1 Day 1.
. Known symptomatic or untreated or recently treated (Less than 6 months of screening) central nervous system (CNS) metastases or CNS lymphoma or CNS leukemia. Patients with previously treated (greater than 6 months of screening) CNS metastases or CNS lymphoma or CNS leukemia and are now stable and asymptomatic, from CNS perspective, are allowed.