A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, PK and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors

CStone Pharmaceuticals1 site in 1 country18 target enrollmentJune 14, 2018

ConditionsSolid Tumor, Adult

InterventionsCS3006

DrugsCS3006

Overview

Phase: Phase 1
Intervention: CS3006
Conditions: Solid Tumor, Adult
Sponsor: CStone Pharmaceuticals
Enrollment: 18
Locations: 1
Primary Endpoint: Number of participants with adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a multicenter, open label, dose escalation & expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006.

Registry

clinicaltrials.gov

Start Date

June 14, 2018

End Date

June 18, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

CStone Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
•ECOG performance status of 0 or
•Life expectancy ≥12 weeks.
•Able to swallow and retain oral medication.
•Subjects must have adequate organ function.
•Use of effective contraception.

Exclusion Criteria

•Subjects receiving anti-cancer therapy at the time of enrollment.
•Subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other systemic anti-cancer treatment, within 14 days prior to the first dose of CS3006 or who has not recovered from adverse events due to a prior therapy.
•Receipt of any prior therapy with a MEK inhibitor.
•Use of any investigational anti-cancer drug within 28 days before the first dose of CS
•Current use of a prohibited medication or use during treatment of CS
•Current use of warfarin.
•Any condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
•History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
•Visible retinal pathology as assessed by ophthalmologic exam.
•Intraocular pressure \> 21mm Hg as measured by tomography.