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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02191761

Enrollment

Registered

2014-07-16

Start date

2014-06-19

Completion date

2015-05-20

Last updated

2018-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Gastric Cancer, Hepatic Cancer, Pancreatic Cancer

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.

Interventions

DRUGSM04755

Escalating Doses

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Determine the MTD	28 days

Secondary

Measure	Time frame
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
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
Time to maximum plasma concentration	30 Days
Accumulation ratio of SM04755	30 Days
Total Clearance of SM04755 after oral administration	30 days
Volume of Distribution of SM04755	30 Days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026