Clinical trial NCT03119467: Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas
Official title: A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients With Relapsed or Refractory Lymphomas
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Lymphoma
Lead sponsor: Rhizen Pharmaceuticals SA
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD) Determination
timeFrame: 28 days
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax).
timeFrame: 24 hrs
measure: Area under the curve (AUC)
timeFrame: 24 hrs
measure: Anti-tumor activity-Overall response rate (ORR)
timeFrame: 2 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Duarte
country: United States
facility: City of Hope
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Sidney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Benowa
country: Australia
facility: Pindara Private Hospital
state: Queensland
city: Greenslopes
country: Australia
facility: Brisbane Clinic for Lymphoma, Myeloma and Leukaemia
state: Queensland
city: Richmond
country: Australia
facility: Epworth HealthCare
state: Victoria
Study officials:
References: