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| Sponsored by: |
OSI Pharmaceuticals |
| Information provided by: | OSI Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00073502 |
Purpose
Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.
| Condition | Intervention | Phase |
|
Gastroesophageal Adenocarcinoma Gastric Adenocarcinoma |
Drug: OSI-7904L |
Phase II |
| MedlinePlus related topics: | Cancer |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Study of Single Agent OSI-7904L In Patients With Locally Advanced or Metastatic Adenocarcinoma Of the Stomach or Gastroesophageal Junction |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age >= 18 years At least one target lesion
Exclusion Criteria:
Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable
Contacts and Locations| United States, Pennsylvania | |||||
| University of Pennsylvania Cancer Center | |||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| United States, Texas | |||||
| MD Anderson Cancer Center | |||||
| Houston, Texas, United States, 77030 | |||||
| United States, Utah | |||||
| University of Utah, Huntsman Cancer Institute | |||||
| Salt Lake City, Utah, United States, 84112 | |||||
| Belgium | |||||
| Dept Internal Medicine Gastrointestinal Oncology Unit | |||||
| B-3000 Leuven, Belgium | |||||
| United Kingdom | |||||
| NICCTU, East Podium, C-Floor | |||||
| Belfast, United Kingdom, BT9 7AB | |||||
| Beatson Oncology Centre | |||||
| Glasgow, United Kingdom, G11 6NT | |||||
| Department of Medical Oncology | |||||
| Manchester, United Kingdom, M20 4BX | |||||
| Cookridge Hospital | |||||
| Leeds, United Kingdom, LS16 6BB | |||||
| United Kingdom, Avon | |||||
| Bristol Haematology & Oncology Centre | |||||
| Bristol, Avon, United Kingdom, BS2 8ED | |||||
| United Kingdom, Oxfordshire | |||||
| ICRF Medical Oncology Unit | |||||
| Oxford, Oxfordshire, United Kingdom, OX3 7LJ | |||||
| United Kingdom, West Midlands | |||||
| Deanesly Centre | |||||
| Wolverhampton, West Midlands, United Kingdom, WV10 0QP | |||||
| OSI Pharmaceuticals |
More Information
| Study ID Numbers: | OSI-904-201 |
| First Received: | November 21, 2003 |
| Last Updated: | February 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00073502 |
| Health Authority: | United States: Food and Drug Administration |
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