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

NCT ID: NCT02191761

Last Updated: 2018-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-19

Study Completion Date

2015-05-20

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Gastric Cancer Hepatic Cancer Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SM04755

Group Type EXPERIMENTAL

SM04755

Intervention Type DRUG

Escalating Doses

Interventions

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SM04755

Escalating Doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosplice Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scottsdale, Arizona, United States

Site Status

La Jolla, California, United States

Site Status

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SM04755-ONC-01

Identifier Type: -

Identifier Source: org_study_id

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