Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
Status: | Recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/10/2019 |
Start Date: | May 11, 2017 |
End Date: | May 2020 |
Contact: | Prajak Barde, MD |
Email: | pjb@rhizen.com |
Phone: | +41 32 580 0113 |
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or
Refractory Lymphomas
Refractory Lymphomas
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).
(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).
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.
We found this trial at
7
sites
Click here to add this to my saved trials
4100 John R
Detroit, Michigan 48201
Detroit, Michigan 48201
800-527-6266
Phone: 734-325-3832
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Cleveland, Ohio 44012
Principal Investigator: Paolo Caimi, MD
Phone: 216-844-0139
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials