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| Name | Class |
|---|---|
| Exelixis | INDUSTRY |
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The purpose of this study is to determine the safety of BMS-833923 (XL139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-833923 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-833923 (XL139) | Drug | Capsules, Oral, 30 mg starting; dose escalation, Once daily, 37 days; additional days if receiving benefit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Use National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) to establish the maximum tolerated dose, a recommended Phase 2 dose range and schedule, and safety profile of BMS-833923 | Use NCI CTCAE to monitor safety assessments including physical findings, laboratory tests, and radiographic assessments to establish the maximum tolerated dose and recommended Phase 2 dose range and schedule of BMS-833923 | On average a minimum of 60 days up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose and during daily dosing: Maximum observed plasma concentration (Cmax) | Study day 1-7, 36 | |
| Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose and during daily dosing: Time of maximum observed plasma concentration (Tmax) |
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For additional information, please contact the BMS oncology clinical trial information service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit www.BMSStudyConnect.com for more information on clinical trial participation.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States | ||
| Southwest Texas Addiction Research And Tech (Start) Center |
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| ID | Term |
|---|---|
| D002280 | Carcinoma, Basal Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C583051 | BMS-833923 |
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| Study day 1-7, 36 |
| Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-t)] of BMS-833923 (XL139) | Study day 1-7 |
| Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-833923 (XL139) | Study day 1-7 |
| Pharmacokinetic parameters of BMS-833923 (XL139) following a single-dose: Plasma half-life (T-HALF) of BMS-833923 (XL139) | Study day 1-7 |
| Pharmacokinetic parameters of BMS-833923 (XL139) during daily dosing: Minimum observed plasma concentration (Cmin) of BMS-833923 (XL139) | Study day 1, 8, 15, 22, 29, 36, 64, and 92 |
| Pharmacokinetic parameters of BMS-833923 (XL139) during daily dosing: Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-833923 (XL139) | Study day 36 |
| To assess the pharmacodynamic effects of BMS-833923 (XL139) on Hedgehog (HH) pathway activation in skin by evaluation of biomarkers such as, but not limited to GLI-1 protein or mRNA expression using immunohistochemistry (IHC) or RT-PCR in a skin biopsies | glioma-associated oncogene family of transcription factors (GLI) | At screening (baseline) and between days 22 and 36 of treatment |
| To assess the pharmacodynamic effects of BMS-833923 (XL139) on HH pathway activation in subjects' tumors by evaluation of protein and mRNA of biomarkers such as, but not limited to GLI-1, in pre- and during-treatment tumor samples | glioma-associated oncogene family of transcription factors (GLI) | At screening (baseline) and between days 22 and 36 of treatment. At screening only for NSCLC patients |
| To describe any preliminary evidence of anti-tumor activity of BMS-833923 (XL139) | Tumor assessments by computed tomography (CT) | Every 8 weeks until disease progression |
| Safety profile of multiple doses of BMS-833923 | Medical review of adverse event reports | Adverse event reports: On average a minimum of 60 days up to 3 years |
| Safety profile of multiple doses of BMS-833923 | The results of vital sign measurements, electrocardiogram (ECGs), pulmonary function tests, multigated radionuclide angiography (MUGA) or echocardiograms, physical examinations, and clinical laboratory tests | Conducted at least on days 1, 8, 15, 22 and 36 of the first 36-day cycle and then monthly or biweekly for the first 6 months, then monthly |
| San Antonio |
| Texas |
| 78229 |
| United States |
| Local Institution | Toronto | Ontario | M5G 2M9 | Canada |
| D018295 |
| Neoplasms, Basal Cell |