Lymphoma
Conditions
Brief summary
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas
Detailed description
Safety: Treatment-Emergent Adverse Events (AE); Treatment related AE, Serious Adverse Events (SAE) and Clinical significant AE; Dose Limiting Toxicities (DLT). Pharmacokinetics (PK): Peak Plasma Concentration (Cmax), Area under the plasma concentration versus time curve (AUC), Time of Maximum Concentration Observed (Tmax). Efficacy: Overall Response Rate (ORR), Progression Free Survival (PFS); Overall Survival (OS) and duration of Response (DoR).
Interventions
DRUGRP4010
Escalating doses starting at 25 mg
Sponsors
Rhizen Pharmaceuticals SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Refractory to or relapsed after at least 1 prior treatment line. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Patients must be ≥18 years of age * Able to give a written informed consent.
Exclusion criteria
* Patients receiving cancer therapy within 3 weeks prior to Cycle1 Day1 (C1D1). * Patients with active Hepatitis B virus (HBV), Hepatitis C virus (HCV) or Human immune deficiency virus (HIV) infection * Patients who received Allo-Stem cell Transplantation(Allo-SCT) within 12 months. * Patients with graft versus-host disease (GVHD) * Subjects who have received drugs that directly or indirectly inhibit calcineurin or Nuclear Factor of activated T cells (NFAT) activity . * Patient with symptomatic, or history of documented congestive heart failure (NY Heart Association functional classification III-IV); * Patient with Frederica's (QTcF) formulas (QTcF) ≥450 msec; * Patient with angina not well-controlled by medication; * Women who are pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Tolerated Dose (MTD) Determination | 28 days | To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax). | 24 hrs | To assess the Maximum Plasma Concentration (Cmax). |
| Area under the curve (AUC) | 24 hrs | To assess the Area under the plasma concentration versus time curve (AUC) |
| Anti-tumor activity-Overall response rate (ORR) | 2 months | To assess the anti-tumor activity of RP4010 as determined by overall response rate (ORR) |
Countries
Australia, United States
Outcome results
None listed