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Sponsored by: |
OSI Pharmaceuticals |
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Information provided by: | OSI Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00073502 |
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 |
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 |
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
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 |
Study ID Numbers: | OSI-904-201 |
Study First Received: | November 21, 2003 |
Last Updated: | February 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00073502 |
Health Authority: | United States: Food and Drug Administration |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Stomach Neoplasms |
Gastrointestinal Neoplasms Stomach cancer Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |