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

Phase 1

Completed

• Conditions: Hepatic Cancer; Gastric Cancer; Colorectal Cancer; Pancreatic Cancer
• Interventions: Drug: SM04755

• Registration Number: NCT02191761
• Lead Sponsor: Biosplice Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-19
• Study First Submitted: 2014-06-30
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Primary Completion: 2015-05-20
• Study Completion: 2015-05-20
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SM04755	SM04755	-

Primary Outcome Measures

Name	Time	Method
Determine the MTD	28 days

Secondary Outcome Measures

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