A Study of CS3006 in Subjects with Locally Advanced or Metastatic Solid Tumors

NCT03516123 | Completed Phase 1

• 1 other identifier: CS3006-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor, Adult

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events

  From the day of first dose to 30 days after last dose of CS3006

Study Arms (1)

CS3006

EXPERIMENTAL

Participants will receive CS3006 orally at specified dose on specified days

Drug: CS3006

Interventions

CS3006 DRUG

In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, participants will receive CS3006 at specified dose level(s).

Also known as: MEK inhibitor

CS3006

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.
• Life expectancy ≥12 weeks.
• Able to swallow and retain oral medication.
• Subjects must have adequate organ function.
• Use of effective contraception.

You may not qualify if:

• 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 CS3006.
• Current use of a prohibited medication or use during treatment of CS3006.
• 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.
• Glaucoma diagnosed within one month prior to the first dose of CS3006.
• Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
• Primary malignancy of CNS.
• Evidence of severe or uncontrolled systemic diseases.
• Subjects with clinically significant cardiovascular disease.

Sponsors & Collaborators

• CStone Pharmaceuticals: lead

Study Sites (1)

St Vincent's hospital

Sydney, New South Wales, 2010, Australia

Location

MeSH Terms

Interventions

MEK inhibitor I

Study Officials

• Yaling Huang

  CStone Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2018
• First Posted: May 4, 2018
• Study Start: June 14, 2018
• Primary Completion: June 18, 2020
• Study Completion: June 18, 2020
• Last Updated: September 19, 2024

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)