Solid Tumor, AdultPhase 1NCT03516123
A Study of CS3006 in Subjects with Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing CS3006 in people with Solid Tumor, Adult, run by CStone Pharmaceuticals at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- CS3006
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteAustralia
- Study dates
- 14 Jun 2018to 18 Jun 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Able to swallow and retain oral medication.
- Subjects must have adequate organ function.
- Use of effective contraception.
Who cannot join
- Subjects receiving anti-cancer therapy at the time of enrollment.
- 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.
- Receipt of any prior therapy with a MEK inhibitor.
- Use of any investigational anti-cancer drug within 28 days before the first dose of CS3006.
- Current use of a prohibited medication or use during treatment of CS3006.
- Current use of warfarin.
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- Any condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
- History of retinal vein occlusion (RVO) or central serous retinopathy (CSR).
- Visible retinal pathology as assessed by ophthalmologic exam.
- Intraocular pressure > 21mm Hg as measured by tomography.
- Glaucoma diagnosed within one month prior to the first dose of CS3006.
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Primary malignancy of CNS.
- Evidence of severe or uncontrolled systemic diseases.
- Subjects with clinically significant cardiovascular disease.
- QTc interval >= 450 msecs for male or >= 470 msecs for female
- Known history of HIV.
- Subjects with active Hepatitis B or C infection
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CS3006
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS3006Drug
Also called MEK inhibitor
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).
| Study group | Role | What they receive |
|---|---|---|
| CS3006 | Experimental | Participants will receive CS3006 orally at specified dose on specified days Receives: Drug: CS3006 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: From the day of first dose to 30 days after last dose of CS3006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study start14 Jun 2018
- Primary completion18 Jun 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaling Huang, Study director, CStone Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03516123
- Sponsor's protocol ID
- CS3006-101
- Status last verified
- Mar 2020
- First submitted
- 22 Apr 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03516123
- Acronym / sponsor ID
- CS3006-101
- Conditions
- Solid Tumor, Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 18 Jun 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 4 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open label, dose escalation \& expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS3006 | Experimental | Drug: CS3006Participants will receive CS3006 orally at specified dose on specified days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.
- ECOG performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- Able to swallow and retain oral medication.
- Subjects must have adequate organ function.
Key exclusion criteria (20 listed)
- Subjects receiving anti-cancer therapy at the time of enrollment.
- 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.
- Receipt of any prior therapy with a MEK inhibitor.
- Use of any investigational anti-cancer drug within 28 days before the first dose of CS3006.
- Current use of a prohibited medication or use during treatment of CS3006.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CS3006Also: MEK inhibitorIn 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). | Drug | CS3006 |
Primary outcome
Number of participants with adverse events
Time frame: From the day of first dose to 30 days after last dose of CS3006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaling Huang study director
CStone Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS3006 in people with Solid Tumor, Adult, run by CStone Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: From the day of first dose to 30 days after last dose of CS3006). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.