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
1 other identifier
interventional
13
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 colorectal-cancer
Started Jun 2014
Shorter than P25 for phase_1 colorectal-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 19, 2014
CompletedFirst Submitted
Initial submission to the registry
June 30, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2015
CompletedSeptember 7, 2018
September 1, 2018
11 months
June 30, 2014
September 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the MTD
28 days
Secondary Outcomes (9)
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
- +4 more secondary outcomes
Study Arms (1)
SM04755
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Scottsdale, Arizona, 85258, United States
Unknown Facility
La Jolla, California, 92121, United States
Unknown Facility
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2014
First Posted
July 16, 2014
Study Start
June 19, 2014
Primary Completion
May 20, 2015
Study Completion
May 20, 2015
Last Updated
September 7, 2018
Record last verified: 2018-09