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

Sponsor
Biosplice Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02191761
Collaborator
(none)
13
Enrollment
3
Locations
1
Arm
11
Actual Duration (Months)
4.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
13 participants
Allocation:
N/A
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 :
Jun 19, 2014
Actual Primary Completion Date :
May 20, 2015
Actual Study Completion Date :
May 20, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: SM04755

Drug: SM04755
Escalating Doses

Outcome Measures

Primary Outcome Measures

  1. Determine the MTD [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 [28 days]

  2. Area under the plasma concentration (AUC) Versus Time Curve of SM04755 [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) [8 weeks]

  4. Maximum Observed Plasma Concentration (Cmax) of SM04755 [30 Days]

  5. Half Life of SM04755 [30 Days]

  6. Volume of Distribution of SM04755 [30 Days]

  7. Time to maximum plasma concentration [30 Days]

  8. Accumulation ratio of SM04755 [30 Days]

  9. Total Clearance of SM04755 after oral administration [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Scottsdale Arizona United States 85258
2 La Jolla California United States 92121
3 Houston Texas United States 77030

Sponsors and Collaborators

  • Biosplice Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Biosplice Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02191761
Other Study ID Numbers:
  • SM04755-ONC-01
First Posted:
Jul 16, 2014
Last Update Posted:
Sep 7, 2018
Last Verified:
Sep 1, 2018
Additional relevant MeSH terms:
Pancreatic Neoplasms
Liver Neoplasms

Study Results

No Results Posted as of Sep 7, 2018