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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Page 1 of 1 (3 locations)

1

Scottsdale, Arizona, United States, 85258

2

La Jolla, California, United States, 92121

3

Houston, Texas, United States, 77030