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| Name | Class |
|---|---|
| Kyowa Hakko Kirin UK, Ltd. | INDUSTRY |
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The aim of this study is to determine the safety, tolerability and dose-limiting toxicities of KW-2478 and to determine the Maximum Tolerated Dose and recommended Phase II dose for patients with relapsed/refractory MM, CLL or B-cell NHL.
This is a Phase I, open-label, dose-escalation study of KW-2478 in patients with relapsed/refractory multiple myeloma, chronic lymphocytic leukaemia or B-cell Non-Hodgkin's lymphoma who have no established therapeutic alternatives. Up to 42 patients will be enrolled at up to six investigational sites over a period of approximately 12 months until an MTD is reached. An additional 12 patients may be enrolled at the MTD in an expanded cohort of one or more of the eligible conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental | Intravenous KW-2478 (ascending dose cohorts) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KW-2478 | Drug | Daily intravenous KW-2478 for 5 days in 14-day cycles, ascending dose cohorts |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine Safety & Tolerability by adverse event rates in order to determine recommended Phase II dose | At every visit and at the end of each 14-day treatment cycle |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics and Pharmacodynamics | At baseline and steady state during cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Responsible Medical Officer KHKUK | Kyowa Hakko Kirin UK | Study Director |
| J D Cavenagh, MD. MRCP, MRCPath | St Bartholomew's Hospital, London, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomew's Hospital | London | United Kingdom | ||||
| UCLH |
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| London |
| United Kingdom |
| Christie Hospital | Manchester | United Kingdom |
| Nottingham University NHS Trust | Nottingham | United Kingdom |
| Cancer Research UK Clinical Centre | Southampton | United Kingdom |
| Royal Marsden Hospital | Sutton | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D015448 | Leukemia, B-Cell |
| D016393 | Lymphoma, B-Cell |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D007938 | Leukemia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D008206 | Lymphatic Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
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| ID | Term |
|---|---|
| C551428 | KW-2478 |
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