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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02191761
• Other study ID #: SM04755-ONC-01
• Status: Completed
• Phase: Phase 1
• Start date: June 19, 2014
• Est. completion date: May 20, 2015

Study information

• Verified date: September 2018
• Source: Samumed LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 20, 2015
• Est. primary completion date: May 20, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Gastric Cancer
• Hepatic Cancer
• Liver Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Stomach Neoplasms

Intervention

Drug:
• SM04755
Escalating Doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samumed LLC

Country where clinical trial is conducted

United States, 

Outcome

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