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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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

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

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

Study design
Purpose of the study
Allocation to intervention
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 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
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
CStone Pharmaceuticals

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

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

Summary results
Other publications