Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer

Completed · Phase 1

Conditions studied: Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT02191761

Run by

Biosplice Therapeutics, Inc.

People needed

13

Starts

2014-06-19

Expected to finish

2015-05-20

Last updated by the study team

2018-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — La Jolla, California, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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