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

Primary Purpose

Colorectal Cancer, Gastric Cancer, Hepatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SM04755
Sponsored by
Biosplice Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SM04755

Arm Description

Outcomes

Primary Outcome Measures

Determine the MTD

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2014
Last Updated
September 5, 2018
Sponsor
Biosplice Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02191761
Brief Title
Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 19, 2014 (Actual)
Primary Completion Date
May 20, 2015 (Actual)
Study Completion Date
May 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosplice Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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, pharmacokinetics (PK) and pharmacodynamics (PD) of SM04755 administered orally. Upon determination of the maximum tolerated dose (MTD), expansion cohorts may be enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SM04755
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SM04755
Intervention Description
Escalating Doses
Primary Outcome Measure Information:
Title
Determine the MTD
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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
Title
Area under the plasma concentration (AUC) Versus Time Curve of SM04755
Time Frame
30 days
Title
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
Title
Maximum Observed Plasma Concentration (Cmax) of SM04755
Time Frame
30 Days
Title
Half Life of SM04755
Time Frame
30 Days
Title
Volume of Distribution of SM04755
Time Frame
30 Days
Title
Time to maximum plasma concentration
Time Frame
30 Days
Title
Accumulation ratio of SM04755
Time Frame
30 Days
Title
Total Clearance of SM04755 after oral administration
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92121
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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