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| Sponsored by: |
Allos Therapeutics |
| Information provided by: | Allos Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00558727 |
Purpose
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 |
|
Solid Tumors or Non-Hodgkin's Lymphoma |
Drug: RH-1 |
Phase I |
| MedlinePlus related topics: | Cancer Lymphoma |
| 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 |
|
1: Experimental
RH-1
|
Drug: RH-1
RH-1 will be administered via IV infusion over 3 hours once every 21 days.
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lacey Chance | 303-426-6262 | lchance@allos.com |
| Contact: Beth Crump | 303-426-6262 | bcrump@allos.com |
| United States, Colorado | |||||
| University of Colorado Health Science Center | Recruiting | ||||
| Aurora, Colorado, United States, 80010 | |||||
| Contact: Stacy Grolnic 720-848-0655 Stacy.grolnic@UCHSC.edu | |||||
| Principal Investigator: Ross Camidge, MD, Ph.D. | |||||
| United States, Michigan | |||||
| Hudson-Webber Cancer Research Center | Recruiting | ||||
| Detroit, Michigan, United States, 48201 | |||||
| Contact: Karen Forman 313-576-8096 formank@karmanos.org | |||||
| Principal Investigator: Patricia LoRusso, DO | |||||
| United States, Pennsylvania | |||||
| Fox Chase Cancer Center | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19111 | |||||
| Contact: Yuko Nishida 215-214-1472 Yuko.Nishida@fccc.edu | |||||
| Principal Investigator: Roger Cohen, MD | |||||
| United States, Texas | |||||
| Cancer Therapy & Research Center | Recruiting | ||||
| San Antonio, Texas, United States, 78229 | |||||
| Contact: Tracy Miley 210-450-5091 miley@uthscsa.edu | |||||
| Principal Investigator: Alain Catalin Mita, MD | |||||
| Allos Therapeutics |
| Study Chair: | D. Ross Camidge, MD, PhD | University of Colorado Health Science Center |
More Information
| Responsible Party: | Allos Therapeutics, Inc. ( Medical Monitor ) |
| Study ID Numbers: | RH-1-002 |
| First Received: | November 13, 2007 |
| Last Updated: | September 17, 2008 |
| ClinicalTrials.gov Identifier: | NCT00558727 |
| Health Authority: | United States: Food and Drug Administration |
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