Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Cohort 1: 1x10\^6 cells/kg Cohort 2: 1x10\^7 cells/kg

Cohort 3: 1x10\^6 cells/kg Cohort 4: 3x10\^6 cells/kg Cohort 5: 1x10\^7 cells/kg Cohort 6: 3x10\^7 cells/kg

Allogeneic NK cells

Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.

Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor

A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor

DLT is defined as follows:

* Any toxicity at grade 3 or over for 5 days or more
* All grade 4 toxicities
* GVHD at grade 2 or over

RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma

To quantify the persistence of donor NK cells in recipients

GC Biopharma Corp

Seoul National University Hospital

Tae Min Kim/Assistant Professor

Repeated ascending oral doses of 4SC-205.

4SC-205

Klaus Mross, PD Dr. med.

The purpose of the study is to investigate safety and tolerability of repeated ascending oral doses of 4SC-205 in patients with advanced and incurable solid tumors or malignant lymphomas.

Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies

Open Label, Dose Escalation Trial of Oral 4SC-205 in Patients With Advanced Malignancies: First-In-Man Study of a Newly Developed, Oral Inhibitor of Kinesin-spindle Protein, Eg5

4SC AG

Symptoms and General Pathology

Heart and Blood Diseases

Syndrome

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Multiple Myeloma

Neoplasms, Plasma Cell

Hematologic Neoplasms

Leukemia, Lymphocytic, Chronic, B-Cell

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Acute Graft Versus Host Disease

All Drugs and Chemicals

Histone Deacetylase Inhibitors

oral administration dose escalation twice daily (bid)or three times a day (tid) continuous dosing for 21 days per cycle

4SC-202

Andreas Engert, Prof. MD

The purpose of this study is to determine the Maximum Tolerated Dose, Dose Limiting Toxicities and optimal dosing schedule of 4SC-202 investigating its safety, tolerability and pharmacokinetics.

Oral Histone Deacetylase Inhibitor 4SC-202 in Patients With Advanced Hematologic Malignancies (TOPAS)

Open Label, Dose Escalation Study of 4SC-202 in Patients With Advanced Hematologic Malignancies: First-In-Man Study of a Newly Developed, Oral Histone Deacetylase Inhibitor

The safety and tolerability will be determined by occurrence of adverse events (AEs), vital signs (VS) \[body temperature, weight, blood pressure (BP), pulse rate\], electrocardiogram (ECG), performance status and clinical laboratory parameters.

The plasma concentrations of 4SC-202 will be determined at the following time-points:

Cycle 1 Day 1: Pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 8 h, 24 h p.a. Cycle 1 Day 5: Pre-dose, 0.5 h, 1h, 2h Cycle 1 Day 14: Pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 8 h, 24 h p.a. Cycle 2 Day 1: Pre-dose, 0.5 h, 1 h, 2 h, 3 h, 4 h, 5 h, 8 h, 24 h p.a. using AUC0-infinity, AUClast, Cmax, tmax, t1/2, CL/F

The assessment will be performed by assessment of tumor response, duration of response and progression free survival

Anemia

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Hematinics

Epoetin Alfa

The purpose of this study is to observe correction of haemoglobin (Hb) levels in patients receiving chemotherapy as a consequence of a solid tumour, a malignant lymphoma or a multiple myeloma and who are treated with Retacrit™.

This is a non-interventional, descriptive, national, multi-site, longitudinal and prospective observational study in adult patients who are suffering from cancer or malignant blood disease and whose chemotherapy treatment has induced symptomatic anaemia and being treated with Retacrit® to correct haemoglobin levels.

Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology

Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology; Non-interventional, Observational, Prospective Study

Participants who have hemoglobin values between 11 and 12 g/dl after 6 months of treatment.

Observation of blood value development: hemoglobin, hematocrit, reticulocytes, serum iron, ferritin, transferrin saturation

Hospira, now a wholly owned subsidiary of Pfizer

Antineoplastic Agents

Gemcitabine

Antimetabolites

Subjects will receive a single 5-mg (nontherapeutic) dose of gemcitabine (Gemzar®) via an IV push and then treated with Gemcitabine HCl Oral Formulation (D07001-F4)according to assigned cohort (2 mg to 80 mg) on Day 1, 3, 5, 8, 10, and 12 of 4 21-day cycles study treatment period.

Gemcitabine HCl Oral Formulation

Chia-Chi Lin, MD

Wu-Chou Su, MD

Yee Chao, MD

Open-label Phase 1 sequential dose-escalation study of 10 increasing doses (3 to 6 patients each)to determine and characterize the DLTs and MTD of gemcitabine HCl oral formulation (D07001-F4). Patients will be assigned to receive oral D07001-F4 on Days 1, 3, 5, 8, 10, and 12 of 4 21-day cycles each to further characterize safety and tolerability.

Phase1 Study of Gemcitabine HCl Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

An Open Label, Phase 1, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Clinical Activity of Gemcitabine Hydrochloride Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas

MTD will be determined by study structure and DLT will be determined by definition

AEs will be assessed via the CTCAE version 4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor	NCT01212341	Malignant Lymph... Solid Tumors	Allogeneic NK c...	18 Years -	Seoul National University Hospital
Open Label, Dose Escalation Trial of Oral Eg5 Kinesin-spindle Inhibitor 4SC-205 in Patients With Advanced Malignancies	NCT01065025	Advanced and In... Malignant Lymph...	4SC-205	18 Years -	4SC AG
Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor	NCT01212341	Malignant Lymph... Solid Tumors	Allogeneic NK c...	18 Years -	Seoul National University Hospital
Oral Histone Deacetylase Inhibitor 4SC-202 in Patients With Advanced Hematologic Malignancies (TOPAS)	NCT01344707	Advanced Hemato...	4SC-202	18 Years -	4SC AG
Biosimilar Retacrit™ (Epoetin Zeta) in the Treatment of Chemotherapy-Induced Symptomatic Anaemia in Haematology and Oncology	NCT01626547	Chemotherapy-in... Solid Tumours Malignant Lymph... Multiple Myelom...		18 Years -	Hospira, now a wholly owned subsidiary of Pfizer
Phase1 Study of Gemcitabine HCl Oral Formulation(D07001-F4) in Patients With Advanced Solid Malignancies and Malignant Lymphomas	NCT01800630	Advanced Solid ... Malignant Lymph...	Gemcitabine HCl...	20 Years -	InnoPharmax Inc.

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