Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
Sponsor
GPCR Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01018979
Collaborator
(none)
19
6
2
19.9
3.2
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
19 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II, Open-Label, Multi-Center 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
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
Oct 1, 2011
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 (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)
|
| Experimental: 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) |
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)
|
Outcome Measures
Primary Outcome Measures
- 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). [1 week]
Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.
Secondary Outcome Measures
- Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. [Baseline, 3 hours and 6 hours after infusion]
- Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- 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. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- 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. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. [36 hrs after infusion]
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
- Circulating CD34+ Cell Counts in Peripheral Blood. [Baseline, 3 hours and 6 hours after infusion]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
-
At least one year post-menopausal, or
-
Surgically sterile, or
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chang-Gung Memorial Hospital Chiayi | Chiayi | Taiwan | ||
| 2 | Buddist Tzu Chi General Hospital | Hualien | Taiwan | ||
| 3 | Kaohsiung Medical University Hospital | Kaohsiung | Taiwan | ||
| 4 | Chang-Gung Memorial Hospital Linkou | Linkou | Taiwan | ||
| 5 | National Taiwan University Hospital | Taipei | Taiwan | ||
| 6 | Taipei Veterans General Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- GPCR Therapeutics, Inc.
Investigators
- Principal Investigator: Tzeon-Jye Chiou, MD, Taipei Veterans General Hospital, Taiwan
- Principal Investigator: Tso-Fu Wang, MD, Buddist Tzu Chi General Hospital
- Principal Investigator: Sheng-Fung Lin, MD, Kaohsiung Medical University
- Principal Investigator: Chih-Cheng Chen, MD, Chang-Gung Memorial Hospital Chiayi
- Principal Investigator: Po-Nan Wang, MD, Chang Gung Memorial Hospital
- Principal Investigator: Jih-Luh Tang, MD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
GPCR Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01018979
Other Study ID Numbers:
- TG-0054-02
First Posted:
Nov 25, 2009
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Period Title: Overall Study | ||
| STARTED | 7 | 13 |
| Received at Least One Dose | 7 | 12 |
| COMPLETED | 4 | 3 |
| NOT COMPLETED | 3 | 10 |
Baseline Characteristics
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) | Total |
|---|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) | Total of all reporting groups |
| Overall Participants | 7 | 12 | 19 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
47.3
(15.5)
|
52.4
(9.3)
|
50.5
(11.8)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
57.1%
|
7
58.3%
|
11
57.9%
|
| Male |
3
42.9%
|
5
41.7%
|
8
42.1%
|
| Height (centimeters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [centimeters] |
162.7
(10.1)
|
158.7
(8.6)
|
160.2
(9.1)
|
| Weight (kilogram) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilogram] |
67.3
(23.1)
|
60.6
(10.2)
|
63.1
(15.9)
|
| Body Mass Index (kilogram/ meter^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilogram/ meter^2] |
25.1
(6.0)
|
24.0
(3.0)
|
24.4
(4.2)
|
| Diagnosis (participants) [Number] | |||
| Multiple myeloma |
3
42.9%
|
4
33.3%
|
7
36.8%
|
| Non-Hodgkin lymphoma |
3
42.9%
|
7
58.3%
|
10
52.6%
|
| Hodgkin disease |
1
14.3%
|
1
8.3%
|
2
10.5%
|
Outcome Measures
| Title | 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). |
|---|---|
| Description | Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success. |
| Time Frame | 1 week |
Outcome Measure Data
| Analysis Population Description |
|---|
| In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure. In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 4 | 3 |
| MM |
1
14.3%
|
1
8.3%
|
| NHL |
1
14.3%
|
0
0%
|
| HD |
0
0%
|
0
0%
|
| Title | Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [ng/mL] |
20971
(6995)
|
29665
(18583)
|
| Title | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. |
|---|---|
| Description | |
| Time Frame | Baseline, 3 hours and 6 hours after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Multiple Myeloma (MM) | Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD) | All Patients |
|---|---|---|---|
| Arm/Group Description | 7 patients with MM were enrolled. | 10 patients and 2 patients with NHL and HD were enrolled, respectively. | All patents = MM + NHL + HD |
| Measure Participants | 7 | 12 | 19 |
| Fold increase (3 hours after infusion) |
7.0
(5.9)
|
6.1
(6.1)
|
6.4
(5.9)
|
| Fold increase (6 hours after infusion) |
7.8
(7.2)
|
7.8
(10.4)
|
7.8
(9.1)
|
| Fold increase (Maximum increase) |
9.3
(7.5)
|
10.3
(8.9)
|
10.0
(8.4)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | TG-0054 (2.24 mg/kg) |
|---|---|---|
| Comments | Analyze whether the mean fold increase from the baseline to the peak time change was significant or not. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.023 |
| Comments | P values less than 0.05 are considered statistically significant in this study. | |
| Method | t-test, 2 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Comments | Analyze whether the mean fold increase from the baseline to the peak time change was significant or not. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.038 |
| Comments | P values less than 0.05 are considered statistically significant in this study. | |
| Method | t-test, 2 sided | |
| Comments | ||
| Title | Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [hr] |
0.25
(0)
|
0.25
(0)
|
| Title | Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [hr] |
4.65
(0.4)
|
4.28
(0.6)
|
| Title | Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [1/hr] |
0.15
(0.01)
|
0.16
(0.02)
|
| Title | 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. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [hr*ng/mL] |
43610
(7034)
|
55814
(12153)
|
| Title | 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. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [hr*ng/mL] |
43713
(7039)
|
55920
(12170)
|
| Title | Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [mL/ hr/kg] |
52.5
(9.4)
|
58.6
(13.0)
|
| Title | Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [mL/kg] |
351
(62)
|
366
(112)
|
| Title | Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
|---|---|
| Description | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Time Frame | 36 hrs after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion. |
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) |
|---|---|---|
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
| Measure Participants | 6 | 6 |
| Mean (Standard Deviation) [mL/kg] |
179
(64)
|
193
(76)
|
| Title | Circulating CD34+ Cell Counts in Peripheral Blood. |
|---|---|
| Description | |
| Time Frame | Baseline, 3 hours and 6 hours after infusion |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Multiple Myeloma (MM) | Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD) | All Patients |
|---|---|---|---|
| Arm/Group Description | 7 patients with MM were enrolled. | 10 patients and 2 patients with NHL and HD were enrolled, respectively. | All patents = MM + NHL + HD |
| Measure Participants | 7 | 12 | 19 |
| PB CD34+ count (Baseline) |
1.0
(0.7)
|
0.9
(0.5)
|
1.0
(0.6)
|
| PB CD34+ count (3 hours after infusion) |
5.7
(4.0)
|
4.0
(2.1)
|
4.6
(2.9)
|
| PB CD34+ count (6 hours after infusion) |
6.3
(3.9)
|
4.3
(2.7)
|
5.1
(3.3)
|
| PB CD34+ count (Maximum increase) |
7.8
(4.4)
|
5.2
(3.7)
|
6.5
(4.1)
|
Adverse Events
| Time Frame | The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study. | |||
| Arm/Group Title | TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) | ||
| Arm/Group Description | 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 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) | ||
All Cause Mortality |
||||
| TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/7 (28.6%) | 6/12 (50%) | ||
| Surgical and medical procedures | ||||
| ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST | 0/7 (0%) | 3/12 (25%) | ||
| AUTOLOGOUS STEM CELL TRANSPLANT | 0/7 (0%) | 1/12 (8.3%) | ||
| HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION | 1/7 (14.3%) | 0/12 (0%) | ||
| AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION | 1/7 (14.3%) | 0/12 (0%) | ||
| TREATMENT OF NON-HODGKIN LYMPHOMA | 0/7 (0%) | 1/12 (8.3%) | ||
| PEIPHERAL BLOOD STEM CELL HARVEST | 0/7 (0%) | 1/12 (8.3%) | ||
Other (Not Including Serious) Adverse Events |
||||
| TG-0054 (2.24 mg/kg) | TG-0054 (3.14 mg/kg) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/7 (85.7%) | 8/12 (66.7%) | ||
| Blood and lymphatic system disorders | ||||
| LEUKOCYTOSIS | 2/7 (28.6%) | 3 | 2/12 (16.7%) | 2 |
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| DIARRHEA | 1/7 (14.3%) | 1 | 1/12 (8.3%) | 1 |
| EMESIS | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| MILD ABDOMINAL PAIN | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| MILD DIARRHEA | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| NAUSEA | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| General disorders | ||||
| ECCHYMOSIS OVER FEMORAL PUNCTURE SITE | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| FEVER | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| Investigations | ||||
| ABNORMAL DATA OF INCREASE BILIRUBIN | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| INCREASE ALANINE AMINOTRANS-FERASE | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| INCREASE ALPHA-GANNA GLUTAMYL TRANSPEPTIDASE | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| HYPERCALCEMIA | 1/7 (14.3%) | 3 | 0/12 (0%) | 0 |
| HYPOCALCEMIA | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| HYPOCALCIUM | 1/7 (14.3%) | 2 | 0/12 (0%) | 0 |
| HYPOKALEMIA | 1/7 (14.3%) | 1 | 1/12 (8.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| LOW BACK PAIN | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| Nervous system disorders | ||||
| CLONIC OF RIGHT KNEE | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| DIZZINESS | 2/7 (28.6%) | 2 | 1/12 (8.3%) | 1 |
| MILD DIZZINESS | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| MILD HEADACHE | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| NUMBNESS OF FACE | 0/7 (0%) | 0 | 1/12 (8.3%) | 2 |
| NUMBNESS OF FACE AND PALM | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| NUMBNESS OF FACE HANDS AND LEGS | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| NUMBNESS OF LEGS AND LIPS | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| NUMBNESS OF LIPS | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| CHEST TIGHTNESS | 1/7 (14.3%) | 2 | 0/12 (0%) | 0 |
| DRY COUGH | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| ITCHY SKIN | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| Vascular disorders | ||||
| HYPERTENSION | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| HYPOTENSION | 0/7 (0%) | 0 | 1/12 (8.3%) | 1 |
| HYPOTENSION BP 82/51MMHG | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
| HYPOVOLEMIC HYPOTENSION BP 78/56MMHG | 1/7 (14.3%) | 1 | 0/12 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed.
Results Point of Contact
| Name/Title | Chen-En Tsai, M.D., Ph.D. |
|---|---|
| Organization | TaiGen Biotechnology Co., Ltd. |
| Phone | +886-2-8177-7072 ext 1211 |
| cetsai@taigenbiotech.com |
Responsible Party:
GPCR Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01018979
Other Study ID Numbers:
- TG-0054-02
First Posted:
Nov 25, 2009
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021