NCT03119467

Safety and Efficacy Study 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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Rhizen Pharmaceuticals SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	RP4010	Escalating doses starting at 25 mg

Timeline

• Start date: 2017-05-11
• Primary completion: 2019-11-29
• Completion: 2019-12-19
• First posted: 2017-04-18
• Last updated: 2019-12-27

Locations

11 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study