Phase
Condition
Non-hodgkin's Lymphoma
Hematologic Cancer
Lymphoma
Treatment
AUR105
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Males and females ≥ 18 years of age
Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
Acceptable bone marrow and organ function at screening as described below:
ANC ≥ 1500/μL (without WBC growth factor support) Platelet count ≥ 100,000/μL without transfusion support (Patients with lymphoma are allowed with Platelet count ≥ 75,000 / μL) Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb) Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN) AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases) ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases) Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula). (Cockcroft-Gault formula for estimated creatinine clearance [eCrCl]: eCrCl = [140- Age] × Weight [kg] × [0.85 if Female] / [72 × serum creatinine (mg/dL)]).
Ability to swallow and retain oral medications
Histo-pathological diagnosis of a solid tumor, Non-Hodgkin lymphoma or HodgkinLymphoma
Evidence of measurable disease per RECIST, v1.1 for solid tumors (Eisenhauer et al.
- and per Lugano Criteria for Lymphoma (Cheson et al. 2014).
- Standard curative measures do not exist, and patient must have exhausted alleffective therapies, available locally.
At a minimum, solid tumor patients must have received at least two lines ofsystemic therapies in the metastatic incurable settings(these two lines must bein the metastatic setting and not in the earlier stage of cancer).
At a minimum, lymphoma patients must have received at least 2 prior lines ofsystemic therapies. These systemic therapies could be either in the stage II,III or IV.
Exclusion
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 longer, from the Cycle 1 Day 1 of the study.
Presence of an 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
Definitive Radiotherapy within the last 21 days of Cycle 1 Day 1 (limited fieldpalliative radiation is allowed and no restrictions during the screening period orduring the trial)
Use of any investigational agent within 28 days or 5 half-lives (whichever islonger) prior to Cycle 1 Day 1
Use of moderate / strong CYP3A4 inhibitors/inducers or moderate / strong P-gpinhibitor/inducers within 2 weeks or 5 half-lives (whichever is longer) prior toCycle 1 Day 1 (The list of these medications is provided in the first four rows ofTable 5)
Known symptomatic or untreated or recently treated (≤ 6 months of screening) centralnervous system (CNS) metastases or CNS lymphoma. Patients with previously treated (> 6 months of screening) CNS metastases or CNS lymphoma and are now stable andasymptomatic, from CNS perspective, are allowed
Major surgery ≤ 28 days from Cycle 1 Day 1 (major surgery is defined as a procedurerequiring general anesthesia)
Patients with leukemia or myelodysplastic syndrome or multiple myeloma
Active infection requiring systemic therapy.
- Prophylactic use of antibiotics is allowed.
Any infection detected during screening period which is resolved adequatelyaccording to investigator before the Cycle 1 Day 1, is allowed.
Known to be human immunodeficiency virus (HIV) positive or have an acquiredimmunodeficiency syndrome-related illnessKnown active or chronic hepatitis B (HBsAg +ve) or hepatitis C infection (HCV antibody +ve)
The patient who is expected to require any other form of antineoplastic therapy ortargeted therapy while on study.
Uncontrolled congestive heart failure (New York Heart Association [NYHA] Class 2-4),angina, myocardial infarction, cerebrovascular accident, coronary/peripheral arterybypass graft surgery, or transient ischemic attack, or pulmonary embolism within 3months prior to Cycle 1 Day 1
Ongoing cardiac dysrhythmias requiring treatment of any grade or treatment ofcardiac dysrhythmias in past 3 months, before Cycle 1 Day 1
QTc (Bazzett) interval >450 ms for male patients or >460 ms for female patients onECG at screening and/or at Cycle 1 Day 1 predose.
Uncontrolled intercurrent illness including, but not limited to, symptomaticcongestive heart failure, uncontrolled hypertension, unstable angina pectoris,cardiac arrhythmia, active peptic ulcer disease or significant gastritis, activebleeding diatheses, presence
Current swab-positive or suspected (under investigation) Covid19 infection or feverand other signs or symptoms suggestive of Covid-19 infection with recent contact ofperson(s) with confirmed Covid-19 infection, at screening or Day 1 of Cycle 1
History of another primary malignancy within 5 years prior to starting study drug,except for adequately treated basal or squamous cell carcinoma of the skin or cancerof the cervix in situ and the disease under study.
Positive pregnancy test for women of child-bearing potential (WOCBP) at thescreening or enrolment visit
Lactating women or WOCBP who are neither surgically sterilized nor willing to usereliable contraceptive methods (hormonal contraceptive, IUD, or any doublecombination of male or female condom, spermicidal gel, diaphragm, sponge, cervicalcap)
Study Design
Study Description
Connect with a study center
HCG City Cancer Center
Vijayawada, Andhra Pradesh 520002
IndiaSite Not Available
Omega Hospitals
Visakhapatnam, Andhra Pradesh 530040
IndiaSite Not Available
IMS&SUM Hospital
Bhubaneswar, Bhubaneswar 751003
IndiaSite Not Available
Kailash Cancer Hospital and Research Centre
Vadodara, Gujarat 391760
IndiaSite Not Available
Krupamayi Hospital
Aurangabad, Maharashtra 431001
IndiaSite Not Available
Moraya Multi-Speciality Hospital
Pune, Maharasthra 411033
IndiaSite Not Available
ALL India Institute of medical Scieneces
New Delhi, New Delhi 110029
IndiaSite Not Available
All India Institute of Medical Sciences
Bhubaneswar, Odisha 751019
IndiaSite Not Available
Sparsh Hospital and Critical Care
Bhubaneswar, Odisha 751007
IndiaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.