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Trial record 1 of 1 for:    NCT03516123
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A Study of CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03516123
Recruitment Status : Active, not recruiting
First Posted : May 4, 2018
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 22, 2018
First Posted Date  ICMJE May 4, 2018
Last Update Posted Date March 5, 2020
Actual Study Start Date  ICMJE June 14, 2018
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
Number of participants with adverse events [ Time Frame: From the day of first dose to 30 days after last dose of CS3006 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE 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).

Other Name: MEK inhibitor
Study Arms  ICMJE Experimental: CS3006
Participants will receive CS3006 orally at specified dose on specified days
Intervention: Drug: CS3006
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: March 4, 2020)
18
Original Estimated Enrollment  ICMJE
 (submitted: May 2, 2018)
60
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03516123
Other Study ID Numbers  ICMJE CS3006-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CStone Pharmaceuticals
Study Sponsor  ICMJE CStone Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yaling Huang CStone Pharmaceuticals
PRS Account CStone Pharmaceuticals
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP