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

• Sponsor: CStone Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03736850
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.9
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

This is a multicenter, open label, sequential-cohort, dose escalation & expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006 and to establish the Maximum Tolerated Dose (MTD）, if any, Recommended Phase II Doses (RP2Ds) and regimen of CS3006. The study is composed of two parts: Part 1 for dose escalation and Part 2 for dose expansion.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced or Metastatic Solid Tumors	Drug: CS3006	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
• Actual Study Start Date: Oct 19, 2018
• Actual Primary Completion Date: May 15, 2020
• Actual Study Completion Date: May 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CS3006	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).

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events [From the day of first dose to 30 days after last dose of CS3006]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Willing and able to provide written informed consent for the trial.

2. Subjects must have a histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

4. Life expectancy ≥ 12 weeks.

5. Able to swallow and retain oral medication.

6. Subject must have adequate organ function.

7. Use of effective contraception.

Exclusion Criteria:

1. Subjects receiving cancer therapy at the time of enrollment.

2. Has had prior chemotherapy, targeted therapy, immunotherapy or any other agents used as systemic treatment for cancer, within 14 days of the first dose of investigational product administration or who has not recovered from adverse events due to a previously administered agent.

3. Previous treatment with a MEK inhibitor.

4. Use of any investigational anti-cancer drug within 28 days before the first investigational product administration.

5. Current use of a prohibited medication.

6. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.

7. Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.

8. Primary malignancy of the central nervous system.

9. Evidence of severe or uncontrolled systemic diseases.

10. Subjects with clinically significant cardiovascular disease.

11. Human Immunodeficiency Virus (HIV) infection.

12. Subjects with active Hepatitis B or C infection.

13. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational product or excipients.

14. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol.

15. Unwillingness or inability to follow the procedures outlined in the protocol.

For more information regarding trial participation, please contact at [e-mail]

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	People's Liberation Army 307 Hospital	Beijing	Beijing	China

Sponsors and Collaborators

• CStone Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: CStone Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03736850
• Other Study ID Numbers: CS3006-102
• First Posted: Nov 9, 2018
• Last Update Posted: Jan 12, 2021
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jan 12, 2021