aggressive non-Hodgkin's lymphoma MedDRA version: 14.1 Level: LLT Classification code 10025311 Term: Lymphoma (non-Hodgkin's) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Tasidotin HCl
Product Code: Tasidotin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: tasidotin
CAS Number: 623174-20-9
Current Sponsor code: Tasidotin HCl
Other descriptive name
Sponsors
Ergomed Clinical Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Have a histological confirmed aggressive non-Hodgkin’s lymphoma that is not amenable to standard therapy with curative intent or that has progressed or recurred after prior standard therapy. (2) Have received at least 1 line of standard chemotherapy (3) Have at least one measurable lesion by computerized tomography (CT) or other techniques, that has not been previously irradiated, or has grown since the previous irradiation. (4) Male or female patient at least 18 years old. (5) ECOG performance status 0, 1, or 2. See Appendix B. (6) Life expectancy of at least 12 weeks. (7) Patient has adequate organ and immune system function as indicated by the laboratory values in the protocol (8) Any chemotherapy, major surgery, or irradiation must have been completed at least 4 weeks prior to starting treatment with study drug (a minimum 12 weeks or four half-lives whichever is greater for monoclonal antibodies; 12 weeks for vaccines; and 8 weeks for radioimmunotherapy). Additionally, patients must have recovered from clinically significant toxicities incurred as a result of previous therapy except nail dystrophy, alopecia, grade 1 peripheral neuropathy, or local radiation therapy induced effects (impotence or incontinence) (9) Be able to comply with study procedures and follow-up examinations. (10) Not pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy. Acceptable birth control method requires the use of a double-barrier method (meaning the man to use a condom plus additional methods, like oral contraceptives, intra-uterine device, spermicidal foam). (11) Signed informed consent. (12) Patients on immune-suppressive agents such as corticosteroids may be enrolled, however, (s)/he must be on stable dose for at least 4 weeks prior start of study therapy and are planned to continue with the same dose while in the trial Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 23 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: (1) Patients with known or symptomatic or progressive meningeal infiltration. (2) Received previous treatment with Tasidotin HCl or known hypersensitivity to Tasidotin HCl or its analogues. (3) Prior autologous or allogenic marrow or stem cell transplant within 6 months of study entry. (4) Blood transfusions within 4 weeks of study entry. (5) Used any investigational agents during the 30 days prior to the first dose. (6) Has any clinical indication that may affect gastrointestinal (GI) absorption (e.g., diarrhea, ulcers, GI surgery, or other GI abnormalities). (7) History of other malignancy that could affect compliance with the protocol or interpretation of results (8) Has psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. (9) Has uncontrolled congestive heart failure (CHF) or angina, including patients with a history of myocardial infarction within 2 months of enrollment, or patients with cardiac functional capacity Class III or IV as defined by the New York Heart Association Classification. See Appendix D. (10) Has a systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement) despite appropriate antibiotics or other treatment. (11) Known human immunodeficiency virus (HIV) positivity. (12) Has any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo chemotherapy. (13) Patient is a dependant of the investigator or sponsor (e.g., family, relatives, employee…)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of Tasidotin HCl administered orally for 14 consecutive days every 28 days cycle by identifying the MTD when administered in patients with relapsed/refractory aggressive non-Hodgkin’s lymphomas;Secondary Objective: To assess the antitumor activity of oral Tasidotin HCl as measured using the International Workshop Criteria for evaluation of response in Non-Hodgkin’s lymphoma (IWC) 14 in patients with relapsed/refractory aggressive non-Hodgkin’s lymphomas To assess clinical benefit as determined by the Investigator and defined as improvement in Eastern Cooperative Oncology Group (ECOG) performance status and improvement in LDH and ß-2 microglobulin levels (when appropriate) in the absence of an objective tumor response according to IWC To evaluate the pharmacokinetic characteristics of orally administered Tasidotin HCl To determine the recommended Phase 2 dose (RP2D);Primary end point(s): 1. MTD as determined by the DLT(s) ;Timepoint(s) of evaluation of this end point: Last patient, last visit (the trial will finish when the last patient progresses on therapy) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety based on the incidence, severity, causality, and seriousness of adverse events (AEs) and clinical laboratory results. Antitumor activity measured by IWC Clinical benefit as assessed by changes in ECOG performance status and improvement in LDH and ß-2 microglobulin levels (when appropriate) Pharmacokinetic parameters of orally administered Tasidotin HCl and M1 metabolite Pharmacodynamic parameters (POP enzyme activity in tumor, and LDH and ß-2 microglobulin levels when applicable) ;Timepoint(s) of evaluation of this end point: Last patient, last visit (the trial will finish when the last patient progresses on therapy) | — |
Countries
Bosnia and Herzegovina, Germany, Poland, Serbia
Contacts
Public ContactRegulatory Affairs Director
Ergomed Limited
Outcome results
None listed