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Sponsored by: |
Allos Therapeutics |
Information provided by: | Allos Therapeutics |
ClinicalTrials.gov Identifier: | NCT00722553 |
The purpose of this clinical study is to determine the effectiveness (ability to provide a beneficial treatment of the disease) and safety of pralatrexate when given to bladder cancer patients who have received at least 1 prior treatment.
Condition | Intervention | Phase |
Cell Carcinoma Bladder Cancer |
Drug: (2S)-2-[[4-[(1RS)-1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]amino]pentanedioic acid |
Phase II |
Genetics Home Reference related topics: | bladder cancer |
MedlinePlus related topics: | Bladder Cancer Cancer |
Drug Information available for: | Sodium chloride 10-Propargyl-10-deazaaminopterin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Single-Arm Study of Pralatrexate in Patients With Advanced or Metastatic Relapsed Transitional Cell Carcinoma of the Urinary Bladder |
Estimated Enrollment: | 41 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
Pralatrexate
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Drug: (2S)-2-[[4-[(1RS)-1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]amino]pentanedioic acid
All patients will receive pralatrexate at the original concentration of 20 mg/mL infused at a constant rate into a normal saline (0.9% NaCl) peripheral IV line administered over 1 hour on days 1 and 15 of a 4 week cycle (ie, every [q] 2 weeks). The initial dose of pralatrexate will be 190 mg/m2 q 2 weeks which, based on defined criteria, may be reduced to 150 mg/m2. The lowest dose allowed is 150 mg/m2; if a patient cannot tolerate 150 mg/m2 q 2 weeks, pralatrexate must be discontinued.
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This is a Phase 2, open-label, single-arm, multi-center study of pralatrexate administered concurrently with vitamin B12 and folic acid supplementation in patients with advanced or metastatic relapsed transitional cell carcinoma (TCC) of the urinary bladder.
The start of study treatment is defined as the initiation of pralatrexate treatment. All patients will receive pralatrexate over 1 hour on days 1 and 15 of a 4 week cycle.
All patients will receive vitamin therapy on a regimen of folic acid by mouth (PO) once a day (QD) starting at least 7 days prior to enrollment and must receive 1 mg intramuscular (IM) vitamin B12 within 10 weeks of enrollment. Once the patient is enrolled, the dosing of vitamin supplementation will consist of vitamin B12 1 mg IM q 8 10 weeks, and folic acid PO QD.
All patients will be followed for safety until 35 (± 5) days after the last dose of pralatrexate, or until all treatment-related adverse events (AEs) have resolved or returned to baseline/Grade 1, whichever is longer, or until it is determined that the outcome will not change with further follow up.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lacey Chance | 303-426-6262 | lchance@allos.com |
Contact: Marty Huntington | 303-426-6262 | mhuntington@allos.com |
United States, California | |||||
Gregory Smith, MD | Recruiting | ||||
St. Helena, California, United States, 94574 | |||||
Contact: Shellie Kilimen 707-967-3698 kilimensl@ah.org | |||||
Principal Investigator: Gregory Smith, MD | |||||
United States, Georgia | |||||
Peachtree Hematology/Oncology Consultants | Recruiting | ||||
Atlanta, Georgia, United States, 30309 | |||||
Contact: Ann Johnston 678-298-3241 ajohnston@phoc.com | |||||
Principal Investigator: Vasileous Assikis, MD | |||||
Belgium | |||||
Institut Jules Bordet | Recruiting | ||||
Brussels, Belgium, 1000 | |||||
Contact: Tatiana Bessehammer +32 2 541 31 48 Tatiana.bessehammer@bordet.be | |||||
Principal Investigator: Thierry Gil, MD | |||||
Algemeen Ziekenhuis Middelheim Oncology | Recruiting | ||||
Antwerp, Belgium, 2020 | |||||
Contact: Anita Boumans 32 3 280 34 00 Anita.boumans@zna.be | |||||
Principal Investigator: Eric Joosens, MD | |||||
France | |||||
Institut Sainte Catherine | Recruiting | ||||
Avignon, France, 84082 | |||||
Contact: Armelle Rollet + 33 4 90 27 62 74 a.rollet@isc84.org | |||||
Principal Investigator: Werner Hilgers, MD | |||||
Centre Oscar Lambret | Recruiting | ||||
Lille Cedex, France, 59020 | |||||
Contact: Edith Lesieu 33 3 20 29 55 69 e-lesieu@o-lambret.fr | |||||
Principal Investigator: Armelle Caty, MD | |||||
Institut Gustave Roussy | Recruiting | ||||
Villejuif Cedex,, France, 94 805 | |||||
Contact: Sophie Pellegrino 33 1 42 11 64 40 sophie.pellegrino@igr.fr | |||||
Principal Investigator: Karim Fizazi, MD | |||||
Spain | |||||
Hospital Del mar - Bracelona | Recruiting | ||||
Barcelona, Spain, 8003 | |||||
Contact: Marta Macia 34 93 248 36 09 mmacia@imas.imim.es | |||||
Principal Investigator: Joaquim Belmunt, MD |
Allos Therapeutics |
Responsible Party: | Allos Therapeutics, Inc. ( Beth Crump ) |
Study ID Numbers: | PDX-011 |
First Received: | July 23, 2008 |
Last Updated: | September 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00722553 |
Health Authority: | United States: Food and Drug Administration |
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