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Sponsored by: |
Aronex Pharmaceuticals |
Information provided by: | Aronex Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00081549 |
This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and gemcitabine (Gemzar®) in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. In Phase II, the primary objective is to evaluate survival after therapy with Aroplatin and gemcitabine at the identified MTD in subjects with unresectable, locally advanced and/or metastatic pancreatic cancer. Secondary objectives are to evaluate the severity and quantity of adverse events and determine the proportion of non-progressors and the progression-free interval.
Condition | Intervention | Phase |
Pancreatic Neoplasms |
Drug: Aroplatin (Liposomal NDDP, L-NDDP) |
Phase I Phase II |
MedlinePlus related topics: | Cancer Pancreatic Cancer |
ChemIDplus related topics: | Gemcitabine hydrochloride Gemcitabine Pancrelipase Ultrase |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Study of Aroplatin and Gemcitabine In Subjects With Unresectable, Locally Advanced And/Or Metastatic Pancreatic Cancer |
Estimated Enrollment: | 111 |
Phase I Primary Objective:
Phase II Primary Objective:
Phase II Secondary Objective:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
Study ID Numbers: | C-726-02 |
First Received: | April 15, 2004 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00081549 |
Health Authority: | United States: Food and Drug Administration |
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