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| Sponsored by: |
Ascenta Therapeutics |
| Information provided by: | Ascenta Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00561197 |
Purpose
This is a Phase 1/ 2, open-label, single-center study of preoperative chemoradiotherapy and AT-101 in patients with locally advanced esophageal or gastroesophageal junction cancer.
| Condition | Intervention | Phase |
|
Locally Advanced Esophageal or GE Junction Cancer |
Drug: AT-101 |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Esophagus Disorders |
| Drug Information available for: | Docetaxel Fluorouracil |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | An Open-Label, Single-Center, Phase 1/ 2 Study of Chemoradiotherapy and AT-101 in Patients With Locally Advanced Esophageal or Gastroesophageal Junction Cancer |
| Estimated Enrollment: | 48 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2009 |
| Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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: Kimberli Brill | 610-725-1506 | kbrill@ascenta.com |
| Contact: Lance Leopold, MD | 610-408-0301 | lleopold@ascenta.com |
| United States, Texas | |||||
| MD Anderson Cancer Center | Recruiting | ||||
| Houston, Texas, United States | |||||
| Contact: Angela Welch 713-792-2172 | |||||
| Ascenta Therapeutics |
| Study Director: | Lance Leopold, MD | Ascenta Therapeutics, Inc. |
More Information
| Responsible Party: | Ascenta Therapeutics ( Melissa Brookes, Sr. Project Manager, Clinical Development ) |
| Study ID Numbers: | AT-101-CS-102 |
| First Received: | November 19, 2007 |
| Last Updated: | July 21, 2008 |
| ClinicalTrials.gov Identifier: | NCT00561197 |
| Health Authority: | United States: Food and Drug Administration |
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