Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/9/2018 |
| Start Date: | June 19, 2014 |
| End Date: | May 20, 2015 |
Phase1, Open-Label, Dose Escalation, Dose-Finding Study Evaluating the Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
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.
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.
Inclusion Criteria:
- Subjects with advanced colorectal, gastric, hepatic or pancreatic cancer
- Subjects must have recovered from all toxicity associated with previous chemotherapy,
targeted therapy, or radiotherapy
- Subjects must meet certain laboratory criteria
- Expected survival > 3months
- Subjects must have no uncontrolled intercurrent illness
Exclusion Criteria:
- Women who are pregnant or lactating, or who are of childbearing potential , and men
who do not use a barrier method
- Subjects with significant cardiac issues
- Subjects using certain medications
- Subjects with certain medical conditions
- Subjects with brain metastasis
- Subjects who have recently been enrolled in other experimental clinical trials of
investigational agents
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