Safety and Pharmacokinetics of SM04755 in Subjects With Advanced Colorectal, Gastric, Hepatic, or Pancreatic Cancer
Conditions
Colorectal Cancer - Gastric Cancer - Hepatic Cancer - Pancreatic Cancer
Conditions: official terms
Liver Neoplasms - Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: SM04755
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Scottsdale, Arizona, United States
Status: Recruiting
Contact: Joyce Schaffer, MSN,RN,AOCNS - 1-877-273-3713 - joschaffer@shc.org
La Jolla, California, United States
Status: Recruiting
Contact: Julio Romero - 858-822-5353 - jcr026@ucsd.edu
Houston, Texas, United States
Status: Recruiting
Contact: Sarina Piha-Paul, M.D. - 713-563-1930
Start Date
June 2014
Completion Date
July 2016
Sponsors
Samumed LLC
Source
Samumed LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page