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

GPCR Therapeutics

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Hodgkin Disease

Non-Hodgkin Lymphoma

Treatments

Drug: TG-0054 (2.24 mg/kg)

Drug: TG-0054 (3.14 mg/kg)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01018979

TG-0054-02

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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