Status:
COMPLETED
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Lead Sponsor:
Biosplice Therapeutics, Inc.
Conditions:
Colorectal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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, pharmaco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 19 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2015
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT02191761
Start Date
June 19 2014
End Date
May 20 2015
Last Update
September 7 2018
Active Locations (3)
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1
Scottsdale, Arizona, United States, 85258
2
La Jolla, California, United States, 92121
3
Houston, Texas, United States, 77030