Safety And Pharmacokinetics Of SM04755 In Subjects With Advanced Colorectal, Gastric, Hepatic, Or Pancreatic Cancer

Study Overview

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.

N/A

Colorectal Cancer
Gastric Cancer
Hepatic Cancer
Pancreatic Cancer

DRUG: SM04755

SM04755-ONC-01

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-06-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-09-05
First Submitted that Met QC Criteria 2014-07-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-09-07
First Posted (ACTUAL) 2014-07-16	Results First Posted N/A	Last Verified 2018-09

Study Plan

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

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

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: SM04755

DRUG: SM04755

Escalating Doses

Primary Outcome Measures	Measure Description	Time Frame
Determine the MTD		28 days

Secondary Outcome Measures	Measure Description	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		28 days
Area under the plasma concentration (AUC) Versus Time Curve of SM04755		30 days
Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST)		8 weeks
Maximum Observed Plasma Concentration (Cmax) of SM04755		30 Days
Half Life of SM04755		30 Days
Volume of Distribution of SM04755		30 Days
Time to maximum plasma concentration		30 Days
Accumulation ratio of SM04755		30 Days
Total Clearance of SM04755 after oral administration		30 days

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record