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| Name | Class |
|---|---|
| OSI Pharmaceuticals | INDUSTRY |
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Open label, phase 1, dose escalation
Multicenter, open-label, phase 1, dose escalation study to determine the maximum tolerated dose on both once daily (QD) and twice daily (BID) schedules.
Patients may continue to receive OSI-930 until one of the following occurs: disease progression, adverse event requiring withdrawal, failure to recover from toxicity despite a 14-day dosing interruption, medical or ethical reasons, patient request, or patient death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Once Daily Dosing |
|
| 2 | Experimental | Twice Daily Dosing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OSI-930 | Drug | Oral OSI-930 administered once daily at increasing doses until disease progression or unacceptable toxicity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose (MTD) for both the once daily (QD) and twice daily (BID) dosing schedules and establish a recommended phase 2 dose of OSI-930 | 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, Pharmacokinetic profile, Pharmacodynamic relationships, Preliminary antitumor activity | 2.5 years |
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Inclusion Criteria:
Histologically or cytologically documented malignancy that is now advanced and/or metastatic and refractory to established forms of therapy or for which no effective therapy exists.
Age >/= 18 years, ECOG PS 0-2, life expectancy >/= 12 weeks Prior chemotherapy is permitted provided that a minimum of 3 weeks has elapsed. Prior tyrosine kinase inhibitor therapy is permitted. Patients must have recovered from any treatment-related toxicities (with some exceptions) prior to registration.
Prior hormonal therapy is permitted provided it is discontinued prior to registration (with the exception of prostate cancer patients who have been on hormone therapy for at least 3 months).
Prior radiation therapy is permitted provided that it did not exceed 25% of bone marrow reserve and patients have recovered from the toxic effects. A minimum of 21 days must have elapsed unless the radiotherapy was palliative and nonmyelosuppressive.
ANC >/= 1.5 x 10^9/L, PLT >/= 100 x 10^9/L; bilirubin \
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States | ||
| Dana-Farber Cancer Institute |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D055752 | Small Cell Lung Carcinoma |
| D014594 | Uterine Neoplasms |
| D010051 | Ovarian Neoplasms |
| D007680 | Kidney Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D009362 | Neoplasm Metastasis |
| D015179 | Colorectal Neoplasms |
| D046152 | Gastrointestinal Stromal Tumors |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C505207 | OSI 930 |
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| OSI-930 | Drug | Oral OSI-930 administered twice daily at increasing doses until disease progression or unacceptable toxicity |
|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Cancer Research UK Professor of Medical Oncology | Sutton | Surrey | SM2 5PT | United Kingdom |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002577 | Uterine Cervical Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |