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Completed

NCT Number: NCT02191761

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Hepatic Cancer Intestinal Diseases Intestinal Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Rectal Diseases Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SM04755

Drug

Escalating Doses

Primary outcomes

  1. Determine the MTD

    Time frame: 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Biosplice Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 16, 2014
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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