Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Kyowa Hakko Kogyo Co., Ltd. |
---|---|
Information provided by: | Kyowa Hakko Kirin Pharma, Inc. |
ClinicalTrials.gov Identifier: | NCT00355472 |
This is a Phase I label dose dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell lymphoma (PTCL).
Condition | Intervention | Phase |
---|---|---|
Adult T-Cell Leukemia and Lymphoma (ATL) Adult Peripheral T-Cell Lymphoma (PTCL) |
Drug: KW-0761 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Phase I Dose Escalation Study of KW-0761 in Patients With Relapsed Adult T-Cell Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL) |
Estimated Enrollment: | 20 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
KW-0761
|
Drug: KW-0761
IV administration at 4 escalating dose levels.
|
This is a Phase I open-label dose escalation study of KW-0761 in relapsed patients with CCR4 positive Adult T-Cell Leukemia-Lymphoma (ATL) and Peripheral T-Cell Lymphoma (PTCL). This study is designed to evaluate safety, pharmacokinetics, immunogenicity and preliminary efficacy. Enrollment will proceed until a maximum tolerated dose (MTD) and a recommended Phase II dose (RPIID) have been established.
Ages Eligible for Study: | 20 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Histologically confirmed diagnosis of a CCR4-positive ATL and PTCL that is any of the following:
A. ATL (Adult T-Cell Leukemia-Lymphoma)
B. PTCL (Peripheral T-Cell Lymphoma)
Includes Mycosis Fungoides and Sezary Syndrome;
2: Relapsed to the latest standard chemotherapy;
3: Received at least one prior chemotherapy;
4: After 4 weeks from a prior therapy;
5: Have measurable disease;
6:Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
7: Male or female, at least 20 years and not older than 70 years of age;
8: Signed written informed consent;
9: Stay in hospital for 4 weeks;
10: HBs antigen: negative, HBV-DNA: below the limit of quantification (within 14 days before the study entry);
11: Adequate bone marrow, hepatic and cardiac function including the followings:
Exclusion Criteria:
Responsible Party: | Kyowa Hakko Kogyo, Ltd. ( Study Director ) |
Study ID Numbers: | 0761-0501 |
Study First Received: | July 20, 2006 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00355472 |
Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Adult T-Cell Leukemia ATL Adult Peripheral T-Cell Lymphoma PTCL |
Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders Leukemia-Lymphoma, Adult T-Cell Lymphoma, T-Cell |
Leukemia, T-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma, T-Cell, Peripheral Lymphoma Peripheral T-cell lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |