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Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients

NCT01018979 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-05-11

Study results available
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Summary

A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.

Conditions

Interventions

DRUG

TG-0054 (2.24 mg/kg)

TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

DRUG

TG-0054 (3.14 mg/kg)

TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

Sponsors & Collaborators

  • GPCR Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Tzeon-Jye Chiou, MD · Taipei Veterans General Hospital, Taiwan

  • Tso-Fu Wang, MD · Buddist Tzu Chi General Hospital

  • Sheng-Fung Lin, MD · Kaohsiung Medical University

  • Chih-Cheng Chen, MD · Chang Gung Memorial Hospital, Chiayi

  • Po-Nan Wang, MD · Chang Gung Memorial Hospital

  • Jih-Luh Tang, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01018979 on ClinicalTrials.gov