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

NCT ID: NCT01018979

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-10-31

Brief 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

Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

TG-0054 (2.24 mg/kg)

Intervention Type: DRUG

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

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)

Group Type: EXPERIMENTAL

TG-0054 (3.14 mg/kg)

Intervention Type: DRUG

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

Interventions

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)

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female 18 to 70 years of age inclusive
• Patients with confirmed pathology diagnosis of MM, NHL or HD
• Potential candidate for autologous stem cell transplantation at Investigator's discretion
• ≦ 2 prior regimens of cytotoxic chemotherapy (rituximab, thalidomide, and bortezomib will not be considered as cytotoxic chemotherapy)
• > 4 weeks since last cycle of chemotherapy prior to the study drug administration
• Total dose of melphalan received ≦ 200 mg in the most recent chemotherapy treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Recovered from all acute toxic effects of prior chemotherapy at Investigator's discretion
• White blood cell (WBC) count ≧ 3.0 x 109/L on screening laboratory assessments
• Absolute neutrophil count ≧ 1.5 x 109/L on screening laboratory assessments
• Platelet count ≧ 100 x 109/L on screening laboratory assessments
• Serum creatinine ≦ 2.2 mg/dL on screening laboratory assessments
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin < 2 x upper limit of normal (ULN) on screening laboratory assessments
• Negative for human immunodeficiency virus (HIV)
• Adequate cardiac and pulmonary function to undergo leukapheresis at Investigator's discretion
• For females, one of the following criteria must be fulfilled:

1. At least one year post-menopausal, or

2. Surgically sterile, or

3. Willing to use a double-barrier method [intrauterine device (IUD) plus condom, spermicidal gel plus condom] of contraception throughout the study

• Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from study Day 1 until 28 days after the last dose of TG-0054
• Able to provide the signed informed consent

Exclusion Criteria

• Received radiation therapy around the pelvic or spinal area within 6 months prior to the study drug administration
• >10% bone marrow involvement of lymphoma in NHL patients
• Failed previous stem cell collection [failed to collect 2 x 106 CD34+ cells/kg within 4 apheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)]
• Patients who have undergone previous stem cell transplantation procedure
• Received G-CSF within 2 weeks prior to the study drug administration
• History of other cancer within the past 5 years excluding MM, NHL, HD, basal cell or squamous cell carcinoma of the skin
• History of other hematologic disorders including bleeding or thromboembolic disease
• History of poor and uncontrollable cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, stroke or Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized more than two times a year due to underlying disease
• Diagnosis of sickle cell anemia or documented sickle cell trait
• Uncontrollable malignancy with MM, NHL or HD, or carcinomatous meningitis, at Investigator's discretion
• Any infection required antibiotic treatment or unexplained fever above 38 °C within 3 days prior to dosing
• Pregnant or breast-feeding
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study
• Received any other investigational drug within 1 month before entering the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GPCR Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tzeon-Jye Chiou, MD

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Tso-Fu Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Buddist Tzu Chi General Hospital

Sheng-Fung Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Chih-Cheng Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Chiayi

Po-Nan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Jih-Luh Tang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

Chang-Gung Memorial Hospital Chiayi

Chiayi City, , Taiwan

Buddist Tzu Chi General Hospital

Hualien City, , Taiwan

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Chang-Gung Memorial Hospital Linkou

Linkou District, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

TG-0054-02

Identifier Type: -

Identifier Source: org_study_id