Advanced Solid TumorPhase 1NCT04162301
A Study of CS3002 in Subjects With Advanced Solid Tumors
A Phase 1 study testing CS3002 in people with Advanced Solid Tumor, run by CStone Pharmaceuticals at 2 sites in Australia.
Trial summary
This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS3002 in subjects with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- CS3002
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesAustralia
- Study dates
- 30 Dec 2019to 19 Feb 2021
- 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
- Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Male or female and ≥ 18 years of age on the day of signing informed consent.
- Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor (except SCLC and HPV positive tumors), who has experienced disease progression following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
- Subjects with at least one measurable lesion as defined per RECIST v1.1 (only bone metastasis or CNS as measurable focus is not allowed).
- ECOG performance status ≤ 1.
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- Able to swallow and retain oral medication.
- Subject must have adequate organ function as indicated by the following laboratory values, under the circumstance of not receiving blood transfusion, EPO, Granulocyte Colony-Stimulating Factor (G-CSF) or other medical support within 14 days before study drug administration
- Non-pregnant and non-nursing. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first dose of CS3002 (WOCBP is defined as a sexually active mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 months). WOCBP must agree to remain abstinent (refrain from heterosexual intercourse) or use an acceptable contraceptive method (refer to Appendix 6) from the day of signing informed consent, during the treatment period and for at least 90 days after the last dose of study drug.
- Men must agree to remain abstinent (refrain from heterosexual intercourse) or use an acceptable contraceptive method (refer to Appendix 6) from the day of signing informed consent, during the treatment period and for at least 90 days after the last dose of study drug. Men must refrain from donating sperm during this same period.
- (Part 2 only) Subjects must provide the most recent available sample containing adequate formalin-fixed paraffin-embedded (FFPE) tumor-derived material (tumor blocks or 3 slides minimum) from a core needle biopsy or surgery for analysis of biomarkers, and willing to accept on-treatment biopsy as scheduled in protocol.
Who cannot join
- Prior treatment with any CDK4/6 inhibitor.
- Participation in other studies involving investigational drug(s) within 28 days prior to the first dose of CS3002 and/or during study participation.
- Acceptance of major surgery, chemotherapy, radiotherapy, target therapy, immunotherapy or other anti-cancer therapy within 21 days prior to the first dose of CS3002.
- Prior treatment with drugs that are known to prolong the QT interval within 7 days before the first dose of CS3002.
- Concomitant use of products known to prolong the QT interval or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued ≥ 5 half-lives prior to first dose of CS3002 and withheld throughout the trial until 2 weeks after the last dose of CS3002.
- Any toxic effects of prior anti-cancer therapy or surgical procedures unresolved to baseline severity or NCI-CTCAE Version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion)
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- Diagnosis of any other malignancy within 3 years prior to the first dose of CS3002, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
- Diagnosis of small cell lung cancer and HPV positive tumors.
- Known brain metastasis or other central nervous system (CNS) metastasis that is either symptomatic or untreated. CNS metastases that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by imaging for at least 4 weeks before screening without evidence of cerebral edema and no requirements for corticosteroids or anticonvulsants.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to CS3002, or any of its excipients (refer to Section 6.2.1).
- Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions [pleural, pericardial, peritoneal], and pulmonary lymphangitis).
- Any of the following within 6 months prior to the first dose of CS3002: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI-CTCAE Version 5.0 Grade ≥ 2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
- Presence of active gastrointestinal disease or other condition that will impair significantly with the absorption, distribution, metabolism, or excretion of CS3002.
- Uncontrolled intercurrent illness including, but not limited to, known ongoing or active infection, including HIV, active hepatitis B or C.
- Subjects who are Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive, or Hepatitis C virus (HCV) antibody positive at screening, must not be enrolled until further definite testing with Hepatitis B virus (HBV) DNA titres and HCV RNA tests can conclusively rule out presence of active infection (HBV DNA ≥1000 cps/mL or 200 IU/mL; HCV RNA exceeding the lower detection limit) requiring antiviral therapy with Hepatitis B and C, respectively.
- QTc interval > 480 msec (based on the mean value of the triplicate screening ECG); family or personal history of long or short QT syndrome; history of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia).
- Known or suspected active alcohol or drug abuse.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- Females who are pregnant or lactating.
- For more information regarding trial participation, please contact at cstonera@cstonepharma.com
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Peninsula and South Eastern Haematology and Oncology Group
Heidelberg, Victoria, 3199
About this study
Official title: A Phase I, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activities of CS3002, a CDK4/6 Inhibitor, in Subjects With Advanced Solid Tumors
This is a phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS3002 in subjects with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- CS3002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS3002Drug
CS3002 tablet will be orally administered daily for 3 weeks followed by 1 week off treatment, defining a treatment cycle of 28 days in duration.
| Study group | Role | What they receive |
|---|---|---|
| CS3002 CDK4/6 inhibitor | Experimental | Not described Receives: Drug: CS3002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as assessed by CTCAE v5.0
incidence rate and characteristics of dose-limiting toxicity (DLT); incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes of laboratory values, vital signs and electrocardiogram (ECG) findings. And based on the safety, tolerability, pharmacokinetics, preliminary efficacy, and other available data to determine MTD, RP2D and regimen for CS3002.
Measured: Subjects will be monitored for safety and tolerability throughout the study until 30 ±3 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start30 Dec 2019
- Primary completion19 Feb 2021
- Study completion19 Feb 2021
Why it stopped: The study has been stopped for strategic and business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- CStone Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaling Huang, Study director, CStone Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04162301
- Sponsor's protocol ID
- CS3002-101
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2019
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. 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, Pharmacokinetics and Anti-tumor Activities of CS3002, a CDK4/6 Inhibitor, in Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04162301
- Acronym / sponsor ID
- CS3002-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study has been stopped for strategic and business reasons.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- CStone PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 19 Feb 2021 (actual)
- First posted
- 14 Nov 2019 (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 phase I, open-label, multiple-dose, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of CS3002 in subjects with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS3002 CDK4/6 inhibitor | Experimental | Drug: CS3002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
- Male or female and ≥ 18 years of age on the day of signing informed consent.
- Subjects with histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor (except SCLC and HPV positive tumors), who has experienced disease progression following treatment with all available standard therapy, or for whom treatment is not available, not tolerated or refused.
- Subjects with at least one measurable lesion as defined per RECIST v1.1 (only bone metastasis or CNS as measurable focus is not allowed).
Key exclusion criteria (20 listed)
- Prior treatment with any CDK4/6 inhibitor.
- Participation in other studies involving investigational drug(s) within 28 days prior to the first dose of CS3002 and/or during study participation.
- Acceptance of major surgery, chemotherapy, radiotherapy, target therapy, immunotherapy or other anti-cancer therapy within 21 days prior to the first dose of CS3002.
- Prior treatment with drugs that are known to prolong the QT interval within 7 days before the first dose of CS3002.
- Concomitant use of products known to prolong the QT interval or to be moderate to strong inhibitors/inducers of CYP3A4 which cannot be discontinued ≥ 5 half-lives prior to first dose of CS3002 and withheld throughout the trial until 2 weeks after the last dose of CS3002.
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 |
|---|---|---|
| CS3002CS3002 tablet will be orally administered daily for 3 weeks followed by 1 week off treatment, defining a treatment cycle of 28 days in duration. | Drug | CS3002 CDK4/6 inhibitor |
Primary outcome
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: Subjects will be monitored for safety and tolerability throughout the study until 30 ±3 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first.
incidence rate and characteristics of dose-limiting toxicity (DLT); incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes of laboratory values, vital signs and electrocardiogram (ECG) findings. And based on the safety, tolerability, pharmacokinetics, preliminary efficacy, and other available data to determine MTD, RP2D and regimen for CS3002.
Results and safety
The study was stopped early (reason given: The study has been stopped for strategic and business reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
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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 Pharma
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CS3002 in people with Advanced Solid Tumor, run by CStone Pharmaceuticals at 2 sites 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 11 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: stopped early, as of the sponsor's last update on 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: The study has been stopped for strategic and business reasons.). Results are not available in the source record.
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 as assessed by CTCAE v5.0 (time frame: Subjects will be monitored for safety and tolerability throughout the study until 30 ±3 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first.). 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 15 Apr 2021.