Safety and Efficacy Study of RP4010, in Patients With Relapsed or Refractory Lymphomas

NCT03119467 | Terminated Phase 1 FDA Drug

• 1 other identifier: RP4010-1601
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 11

Brief Summary

A Phase I/Ib, Study to Evaluate Safety and Efficacy of RP4010, in Patients with Relapsed or Refractory Lymphomas

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) Determination

  To determine the maximum tolerated dose of RP4010 in patients with Relapsed or Refractory Non-Hodgkin Lymphoma

  28 days

Secondary Outcomes (3)

• Maximum Plasma Concentration (Cmax).

  24 hrs

• Area under the curve (AUC)

  24 hrs

• Anti-tumor activity-Overall response rate (ORR)

  2 months

Study Arms (1)

Single arm

EXPERIMENTAL

RP4010 to be administered

Drug: RP4010

Interventions

RP4010 DRUG

Escalating doses starting at 25 mg

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rhizen Pharmaceuticals SA: lead

Study Sites (11)

University of Alabama

Birmingham, Alabama, 35294-3300, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Utah Cancer Specialists

Salt Lake City, Utah, 84106, United States

Location

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

Location

Brisbane Clinic for Lymphoma, Myeloma and Leukaemia

Greenslopes, Queensland, 4120, Australia

Location

Epworth HealthCare

Richmond, Victoria, 3121, Australia

Location

MeSH Terms

Conditions

Lymphoma

Interventions

RP4010

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 18, 2017
• Study Start: May 11, 2017
• Primary Completion: November 29, 2019
• Study Completion: December 19, 2019
• Last Updated: December 27, 2019

Record last verified: 2019-12

Locations

AU (4); US (7)