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

Solid Tumor, Adult Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516123
• Other study ID #: CS3006-101
• Status: Completed
• Phase: Phase 1
• Start date: June 14, 2018
• Est. completion date: June 18, 2020

Study information

• Verified date: March 2020
• Source: CStone Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 18, 2020
• Est. primary completion date: June 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Australia	St Vincent's hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		From the day of first dose to 30 days after last dose of CS3006