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Sponsored by: |
Allos Therapeutics |
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Information provided by: | Allos Therapeutics |
ClinicalTrials.gov Identifier: | NCT00558727 |
This is a Phase 1, nonrandomized, open-label, dose-escalation study of 3-hour IV infusions of RH-1 administered to patients with advanced solid tumors or non-Hodgkin's lymphoma (NHL).
Treatment will continue until a patient meets criteria for discontinuation.
Condition | Intervention | Phase |
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Advanced Solid Tumors or Non-Hodgkin's Lymphoma |
Drug: RH-1 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Protocol RH-1-002: A Phase 1 Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Dose-Escalation Study of RH-1 Administered as a 3-Hour Intravenous Infusion in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 60 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
RH-1
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Drug: RH-1
RH-1 will be administered via IV infusion over 3 hours once every 21 days.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Colorado | |
University of Colorado Health Science Center | |
Aurora, Colorado, United States, 80010 | |
United States, Michigan | |
Hudson-Webber Cancer Research Center | |
Detroit, Michigan, United States, 48201 | |
United States, Pennsylvania | |
Fox Chase Cancer Center | |
Philadelphia, Pennsylvania, United States, 19111 | |
United States, Texas | |
Cancer Therapy & Research Center | |
San Antonio, Texas, United States, 78229 |
Study Chair: | D. Ross Camidge, MD, PhD | University of Colorado Health Science Center |
Responsible Party: | Allos Therapeutics, Inc. ( Medical Monitor ) |
Study ID Numbers: | RH-1-002 |
Study First Received: | November 13, 2007 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00558727 |
Health Authority: | United States: Food and Drug Administration |
Advanced Solid Tumors Solid Tumors Tumor |
Non-Hodgkin's Lymphoma Chemotherapy Benzoquinone |
Lymphatic Diseases Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |