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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03516123




Registration number
NCT03516123
Ethics application status
Date submitted
22/04/2018
Date registered
4/05/2018

Titles & IDs
Public title
A Study of CS3006 in Subjects with Locally Advanced or Metastatic Solid Tumors
Scientific title
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
Secondary ID [1] 0 0
CS3006-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Solid Tumor, Adult 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CS3006

Experimental: CS3006 - Participants will receive CS3006 orally at specified dose on specified days


Treatment: Drugs: CS3006
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).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
From the day of first dose to 30 days after last dose of CS3006

Eligibility
Key inclusion criteria
1. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
2. ECOG performance status of 0 or 1.
3. Life expectancy =12 weeks.
4. Able to swallow and retain oral medication.
5. Subjects must have adequate organ function.
6. Use of effective contraception.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects receiving anti-cancer therapy at the time of enrollment.
2. 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.
3. Receipt of any prior therapy with a MEK inhibitor.
4. Use of any investigational anti-cancer drug within 28 days before the first dose of CS3006.
5. Current use of a prohibited medication or use during treatment of CS3006.
6. Current use of warfarin.
7. Any condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
8. History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
9. Visible retinal pathology as assessed by ophthalmologic exam.
10. Intraocular pressure > 21mm Hg as measured by tomography.
11. Glaucoma diagnosed within one month prior to the first dose of CS3006.
12. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
13. Primary malignancy of CNS.
14. Evidence of severe or uncontrolled systemic diseases.
15. Subjects with clinically significant cardiovascular disease.
16. QTc interval >= 450 msecs for male or >= 470 msecs for female
17. Known history of HIV.
18. Subjects with active Hepatitis B or C infection
19. History of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to CS3006.

For more information regarding trial participation, please contact at cstonera@cstonepharma.com

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/06/2020
Sample size
Target
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St Vincent's hospital - Sydney
Recruitment postcode(s) [1] 0 0
2010 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CStone Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yaling Huang
Address 0 0
CStone Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03516123