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
Cleveland, Ohio 44012
Principal Investigator: Paolo Caimi, MD
Phone: 216-844-0139
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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...
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