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

September 5, 2018 updated by: Biosplice Therapeutics, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
    • California
      • La Jolla, California, United States, 92121
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SM04755
Drug: SM04755
Escalating Doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the MTD
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of safety parameters including adverse events, laboratory results, vital signs, electrocardiogram (ECG) findings, Eastern Cooperative Oncology Group (ECOG) performance scores, physical and ophthalmic examination findings
Time Frame: 28 days
28 days
Area under the plasma concentration (AUC) Versus Time Curve of SM04755
Time Frame: 30 days
30 days
Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame: 8 weeks
8 weeks
Maximum Observed Plasma Concentration (Cmax) of SM04755
Time Frame: 30 Days
30 Days
Half Life of SM04755
Time Frame: 30 Days
30 Days
Volume of Distribution of SM04755
Time Frame: 30 Days
30 Days
Time to maximum plasma concentration
Time Frame: 30 Days
30 Days
Accumulation ratio of SM04755
Time Frame: 30 Days
30 Days
Total Clearance of SM04755 after oral administration
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosplice Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2014

Primary Completion (Actual)

May 20, 2015

Study Completion (Actual)

May 20, 2015

Study Registration Dates

First Submitted

June 30, 2014

First Submitted That Met QC Criteria

July 14, 2014

First Posted (Estimate)

July 16, 2014

Study Record Updates

Last Update Posted (Actual)

September 7, 2018

Last Update Submitted That Met QC Criteria

September 5, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM04755-ONC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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