Phase 2
N=20
Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
Multiple Myeloma · Non-Hodgkin Lymphoma · Hodgkin Disease
Bottom Line
View on ClinicalTrials.gov: NCT01018979 ↗Enrolled (actual)
20
Serious AEs
42.1%
Results posted
Jan 2015
Primary outcome: 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). — 1; 1; 1; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TG-0054 (2.24 mg/kg) (Drug); TG-0054 (3.14 mg/kg) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GPCR Therapeutics, Inc.
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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). |
1; 1; 1; 0; 0; 0 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
20971; 29665 | — |
| SECONDARY Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. |
7.0; 6.1; 6.4; 7.8; 7.8; 7.8 | 0.023 sig |
| SECONDARY Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
0.25; 0.25 | — |
| SECONDARY Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
4.65; 4.28 | — |
| SECONDARY Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
0.15; 0.16 | — |
| 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. |
43610; 55814 | — |
| 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. |
43713; 55920 | — |
| SECONDARY Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
52.5; 58.6 | — |
| SECONDARY Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
351; 366 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. |
179; 193 | — |
| SECONDARY Circulating CD34+ Cell Counts in Peripheral Blood. |
1.0; 0.9; 1.0; 5.7; 4.0; 4.6 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT01018979). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.