A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)
NCT ID: NCT05865002
Last Updated: 2024-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
50 participants
INTERVENTIONAL
2023-09-05
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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AUR107, 5mg to 200mg
Currently, planned dose levels are 5 mg QD, 10 mg QD, 20 mg QD, 40 mg QD, 60 mg QD, 90 mg QD, 135 mg QD, and 200 mg QD
AUR107
Once daily
Interventions
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AUR107
Once daily
Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
3. Acceptable bone marrow and organ function at screening as described below:
1. ANC ≥ 1500/μL (without WBC growth factor support)
2. Platelet count ≥ 100,000/μL without transfusion support
3. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)
5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
7. Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula).
4. Ability to swallow and retain oral medications.
5. Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening.
6. Evidence of measurable disease per RECIST, v1.1 for solid tumors.
7. Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally.
Notes:
7a. At a minimum, solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer).
7b. Any cancer patient with access to any effective therapy must not be enrolled
Exclusion Criteria
Note: Concomitant use of low-dose prednisone (up to 10 mg/day) or medroxyprogesterone is allowed.
Note: Patients with CRPC (castrate-resistant prostate cancer) should continue to receive ongoing medical castration with LHRH analogs, and such patients are allowed.
2. Presence of acute or chronic toxicity resulting from prior anticancer treatment, with the exception of alopecia or nail changes, that has not resolved to Grade ≤ 1, as determined by NCI CTCAE v 5.0.
3. 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 longer) prior to Cycle 1 Day 1.
4. Use of drugs which are moderate / strong CYP3A4 inducers and/or drugs which are predominantly metabolized by CYP3A4 within 1week or 5 half-lives (whichever is longer) prior to Cycle 1 Day 1.
• Note: This class of drugs are also prohibited during DLT evaluation period and must be either avoided or used with caution beyond DLT evaluation period.
5. Known symptomatic or untreated or recently treated (≤ 6 months of screening) central nervous system (CNS) metastases. Patients with previously treated (\> 6 months of screening) CNS metastases and are now stable and asymptomatic, from CNS perspective, are allowed.
6. Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedure requiring general anesthesia).
7. Patients with leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma.
8. Active infection requiring systemic therapy. Note: Prophylactic use of antibiotics is allowed. Any infection detected during the screening period which is resolved adequately according to investigator before the Cycle 1 Day 1, is allowed.
9. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome-related illness.
10. Known active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve).
11. The patient who is expected to require any other form of antineoplastic therapy or targeted therapy while on study.
12. Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class 2-4), angina, myocardial infarction, cerebrovascular accident, coronary/peripheral artery bypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3 months prior to Cycle 1 Day 1.
13. Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment of cardiac dysrhythmias in the past 3 months, before Cycle 1 Day 1.
14. QTc (Bazzett) interval \>460 ms on ECG at screening and/or at Cycle 1 Day 1 pre-dose.
15. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or significant gastritis, active bleeding diatheses, presence of any major medical illness (e.g., renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, or psychiatric illness/social situations or clinically significant laboratory / ECG abnormalities at screening, any or a combination of illnesses, which, in the opinion of the PI, may either put the patient at risk because of participation in the study or influence the results or the patient's ability to participate in the study.
16. Current swab-positive or suspected (under investigation) Covid-19 infection or fever and other signs or symptoms suggestive of Covid-19 infection with recent contact of the person(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1.
17. Positive pregnancy test for women of childbearing potential (WOCBP) at the screening or enrolment visit.
18. Lactating women or WOCBP who are neither surgically sterilized nor willing to use reliable contraceptive methods. (hormonal contraceptive, IUD, or any double combination of the male or female condom, spermicidal gel, diaphragm, sponge, cervical cap).
18 Years
ALL
No
Sponsors
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Aurigene Discovery Technologies Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Akhil Kumar
Role: PRINCIPAL_INVESTIGATOR
Aurigene Oncology Limited
Locations
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HCG City Cancer Centre
Vijayawada, Andhra Pradesh, India
Omega Hospital
Visakhapatnam, Andhra Pradesh, India
Unique Hospital Multispeciality and Research Institute
Surat, Gujarat, India
Vydehi Institute of Medical Sciences and Research Centre
Bangalore, Karnataka, India
K R Hospital
Mysore, Karnataka, India
Krupamayi Hospital
Aurangabad, Maharashtra, India
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, India
All India Institute of Medical Sciences
New Delhi, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AUR107-101
Identifier Type: -
Identifier Source: org_study_id
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