← Back to all trials
Completed
NCT02191761
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Conditions: Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 13
Sponsor: Biosplice Therapeutics, Inc.
Location: Scottsdale Arizona
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT02191761). StuddyBuddy aggregates publicly available trial information.