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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSI-7904L | Drug |
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Cancer Center | Philadelphia | Pennsylvania | 19104 | United States | ||
| MD Anderson Cancer Center |
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| Houston |
| Texas |
| 77030 |
| United States |
| University of Utah, Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
| Dept Internal Medicine Gastrointestinal Oncology Unit | B-3000 Leuven | Belgium |
| Bristol Haematology & Oncology Centre | Bristol | Avon | BS2 8ED | United Kingdom |
| ICRF Medical Oncology Unit | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| Deanesly Centre | Wolverhampton | West Midlands | WV10 0QP | United Kingdom |
| NICCTU, East Podium, C-Floor | Belfast | BT9 7AB | United Kingdom |
| Beatson Oncology Centre | Glasgow | G11 6NT | United Kingdom |
| Cookridge Hospital | Leeds | LS16 6BB | United Kingdom |
| Department of Medical Oncology | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| C506644 | ((S)-2-(5-(1,2-dihydro-3-methyl-1-oxobenzo(f)-quinazoline-9-yl)methyl)amino-1-oxo-2-isoindolynyl)-glutaric acid |
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