Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03516123
Recruitment Status : Recruiting
First Posted : May 4, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
CStone Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: CS3006 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
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, PK and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : October 2020

Arm Intervention/treatment
Experimental: CS3006
Participants will receive CS3006 orally at specified dose on specified days
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




Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: From the day of first dose to 30 days after last dose of CS3006 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03516123


Contacts
Layout table for location contacts
Contact: Wendie Yuan +862161097678 cstonera@cstonepharma.com

Locations
Layout table for location information
Australia, New South Wales
Blacktown Cancer and Haematology Centre Recruiting
Blacktown, New South Wales, Australia
Orange Health Service Recruiting
Orange, New South Wales, Australia, 2800
St Vincent's Hospital Sydney Recruiting
Sydney, New South Wales, Australia
Australia, South Australia
Ashford Cancer Centre Research Recruiting
Adelaide, South Australia, Australia, 5037
Australia, Western Australia
Linear Clinical Research Recruiting
Perth, Western Australia, Australia
Sponsors and Collaborators
CStone Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Wanmei Wang CStone Pharmaceuticals

Layout table for additonal information
Responsible Party: CStone Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03516123     History of Changes
Other Study ID Numbers: CS3006-101
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No