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

NCT ID: NCT03516123

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-14
• Study Completion Date: 2020-06-18

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CS3006

Participants will receive CS3006 orally at specified dose on specified days

Group Type: EXPERIMENTAL

CS3006

Intervention Type: 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).

Interventions

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 Type: DRUG

Other Intervention Names

MEK inhibitor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CStone Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaling Huang

Role: STUDY_DIRECTOR

CStone Pharmaceuticals

Locations

St Vincent's hospital

Sydney, New South Wales, Australia

Countries

Australia

Other Identifiers

CS3006-101

Identifier Type: -

Identifier Source: org_study_id