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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01018979
Other study ID # TG-0054-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2010
Est. completion date October 2011

Study information

Verified date April 2021
Source GPCR Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

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)
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)

Locations

Country Name City State
Taiwan Chang-Gung Memorial Hospital Chiayi Chiayi
Taiwan Buddist Tzu Chi General Hospital Hualien
Taiwan Kaohsiung Medical University Hospital Kaohsiung
Taiwan Chang-Gung Memorial Hospital Linkou Linkou
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
GPCR Therapeutics, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD). Patients who met the target CD34+ cell collection of ?2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success. 1 week
Secondary Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. Baseline, 3 hours and 6 hours after infusion
Secondary Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary Terminal Elimination Rate Constant (?z) of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. 36 hrs after infusion
Secondary Circulating CD34+ Cell Counts in Peripheral Blood. Baseline, 3 hours and 6 hours after infusion
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