Trial record 1 of 1 for:
NCT00044551
Evaluation of Bay 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00044551 |
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Recruitment Status :
Completed
First Posted : September 4, 2002
Last Update Posted : October 14, 2013
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Sponsor:
Bayer
Information provided by (Responsible Party):
Bayer
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Brief Summary:
Almost two-thirds of lymphoma cases are Non-Hodgkin's Lymphomas (NHL). NHL is a malignant process that affects lymphoid cells found both in the lymph nodes and extranodally. Incidence and mortality rates from NHL are highest in developed countries. While many patients with aggressive NHL are curable with initial anthracycline-containing regimens, the majority of patients will relapse or prove refractory to initial therapy. The prognosis of patients with disease recurrence following a multidrug regimen is also limited. The current protocol is designed to test the safety and efficacy of BAY 59-8862 in patients with Aggressive Refractory Non-Hodgkin's Lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma, Non-Hodgkin | Drug: Taxane (Cytotoxic, BAY59-8862) | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 29 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open Phase II, Multi Center Trial of BAY 59-8862 in Patients With Aggressive, Refractory Non-Hodgkin's Lymphoma |
| Study Start Date : | February 2002 |
| Actual Study Completion Date : | July 2003 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1 |
Drug: Taxane (Cytotoxic, BAY59-8862)
Daily 1 h infusion every 3 weeks |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: - Measurable disease as defined by the presence of at least one measurable lesion - Failed at least one prior therapy or has achieved remission but has progressed or relapsed within 6 months of therapy - Life expectancy of at least 12 weeks - Adequate bone marrow, liver and kidney function Exclusion Criteria: - Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia, serious infections, HIV infection, chronic hepatitis B or C, seizures, hypersensitivity to taxanes, organ transplants, some previous cancers - Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant - Others: pregnant or breast-feeding patients; both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00044551
Locations
| United States, Florida | |
| Miami Beach, Florida, United States, 33140 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Shreveport, Louisiana, United States, 71130-4228 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08903-2681 | |
| United States, New York | |
| Bronx, New York, United States, 10467-2490 | |
| Brooklyn, New York, United States, 11235-3518 | |
| Manhasset, New York, United States, 11030-3876 | |
| Syracuse, New York, United States, 13210-2399 | |
| Valhalla, New York, United States, 10595 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Tennessee | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Washington | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| France | |
| Paris, France, 75151 | |
| Pierre Benite, France, 69495 | |
| Vandoeuvre-les-nancy, France, 54500 | |
| Germany | |
| Freiburg, Baden-Württemberg, Germany, 79106 | |
| Berlin, Germany, 12200 | |
| Netherlands | |
| Amsterdam, Netherlands, 1081 HV | |
| Groene Hilledijk, Netherlands | |
| United Kingdom | |
| Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ | |
| Maidstone, Kent, United Kingdom, ME16 9QQ | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00044551 |
| Other Study ID Numbers: |
100389 |
| First Posted: | September 4, 2002 Key Record Dates |
| Last Update Posted: | October 14, 2013 |
| Last Verified: | October 2013 |
Keywords provided by Bayer:
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Taxane Lymphoma Non-Hodgkin's Lymphoma |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Taxane IDN 5109 Antineoplastic Agents |