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| Sponsor: | Kyowa Hakko Kirin Pharma, Inc. |
|---|---|
| Information provided by: | Kyowa Hakko Kirin Pharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00199342 |
Purpose
This is a dose escalating cohort study to determine the maximum tolerated dose (MTD) of KW-2871 (in dose cohorts of 60, 80, and 100 mg/m2) when administered with a specified premedication regimen (ranitidine, diphenhydramine, and dexamethasone). KW-2871 will be administered at 14-day intervals.
| Condition | Intervention | Phase |
|---|---|---|
|
Stage IV Melanoma |
Drug: KW-2871 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study of KW-2871 Administered With a Premedication Regimen in Patients With Advanced Stage IV Melanoma |
| Estimated Enrollment: | 48 |
This open label study consists of two parts. Part I, the Phase I component of the study, will be conducted at a single center, and will enroll up to 18 patients with histologically documented Stage IV melanoma (per the American Joint Committee on Cancer [AJCC] criteria) that is not currently amenable to surgical resection or other therapies.
A specified premedication regimen consisting of ranitidine, diphenhydramine, and dexamethasone will be administered to all patients 30 minutes prior to infusion of any dose of KW-2871.
Planned doses of KW-2871 are 60 mg/m2, 80 mg/m2, 100 mg/m2
After identification of the MTD, 30 patients will be enrolled at that dose level in Part II of the study. If no MTD is identified after treatment with the 100 mg/m2 dose level, the dose administered in Part II of the study will be 100 mg/m2. If the MTD is determined as 60 mg/m2, this study will be closed to further patient accrual and will not proceed to Part II.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate end-organ function including:
Exclusion Criteria:
Patients with a history of another malignancy within the last 2 years with the exception of:
Patients requiring maintenance systemic steroid therapy for any condition
-
Contacts and Locations| United States, Alabama | |
| Comprehensive Cancer Center- University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center | |
| Tampa, Florida, United States, 22612 | |
| Principal Investigator: | Andres Forero, MD | Comprehensive Cancer Center University of Alabama |
More Information
| ClinicalTrials.gov Identifier: | NCT00199342 History of Changes |
| Other Study ID Numbers: | 2871-US-002 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 22, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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