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

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ClinicalTrials.gov Identifier: NCT02191761
Recruitment Status : Completed
First Posted : July 16, 2014
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Samumed LLC

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Gastric Cancer Hepatic Cancer Pancreatic Cancer Drug: SM04755 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 19, 2014
Actual Primary Completion Date : May 20, 2015
Actual Study Completion Date : May 20, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SM04755 Drug: SM04755
Escalating Doses




Primary Outcome Measures :
  1. Determine the MTD [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 28 days ]
  2. Area under the plasma concentration (AUC) Versus Time Curve of SM04755 [ Time Frame: 30 days ]
  3. Characterize the pharmacodynamics (PD) of SM04755 by assessment of its preliminary antitumor activity determined by Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 8 weeks ]
  4. Maximum Observed Plasma Concentration (Cmax) of SM04755 [ Time Frame: 30 Days ]
  5. Half Life of SM04755 [ Time Frame: 30 Days ]
  6. Volume of Distribution of SM04755 [ Time Frame: 30 Days ]
  7. Time to maximum plasma concentration [ Time Frame: 30 Days ]
  8. Accumulation ratio of SM04755 [ Time Frame: 30 Days ]
  9. Total Clearance of SM04755 after oral administration [ Time Frame: 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02191761


Locations
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
La Jolla, California, United States, 92121
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Samumed LLC

Responsible Party: Samumed LLC
ClinicalTrials.gov Identifier: NCT02191761     History of Changes
Other Study ID Numbers: SM04755-ONC-01
First Posted: July 16, 2014    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Stomach Neoplasms
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Stomach Diseases
Liver Diseases