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This is an open-label, multi-center, dose escalation study in adult subjects with advanced colorectal, gastric, hepatic or pancreatic cancer. The study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SM04755 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SM04755 | Drug | Escalating Doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the MTD | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings | 28 days | |
| Area under the plasma concentration (AUC) Versus Time Curve of SM04755 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85258 | United States | |||
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| 30 days |
| Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST) | 8 weeks |
| Maximum Observed Plasma Concentration (Cmax) of SM04755 | 30 Days |
| Half Life of SM04755 | 30 Days |
| Volume of Distribution of SM04755 | 30 Days |
| Time to maximum plasma concentration | 30 Days |
| Accumulation ratio of SM04755 | 30 Days |
| Total Clearance of SM04755 after oral administration | 30 days |
| La Jolla |
| California |
| 92121 |
| United States |
| Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D013274 | Stomach Neoplasms |
| D008113 | Liver Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D013272 | Stomach Diseases |
| D008107 | Liver Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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