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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04162301




Registration number
NCT04162301
Ethics application status
Date submitted
29/10/2019
Date registered
14/11/2019
Date last updated
10/03/2020

Titles & IDs
Public title
A Study of CS3002 in Subjects With Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
CS3002-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CS3002

Experimental: CS3002 CDK4/6 inhibitor -


Treatment: Drugs: CS3002
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
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.

Eligibility
Key inclusion criteria
1. 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.

2. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and
other study procedures.

3. Male or female and = 18 years of age on the day of signing informed consent.

4. 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.

5. Subjects with at least one measurable lesion as defined per RECIST v1.1 (only bone
metastasis or CNS as measurable focus is not allowed).

6. ECOG performance status = 1.

7. Able to swallow and retain oral medication.

8. 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

9. 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.

10. 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.

11. (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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior treatment with any CDK4/6 inhibitor.

2. Participation in other studies involving investigational drug(s) within 28 days prior
to the first dose of CS3002 and/or during study participation.

3. Acceptance of major surgery, chemotherapy, radiotherapy, target therapy, immunotherapy
or other anti-cancer therapy within 21 days prior to the first dose of CS3002.

4. Prior treatment with drugs that are known to prolong the QT interval within 7 days
before the first dose of CS3002.

5. 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.

6. 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)

7. 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.

8. Diagnosis of small cell lung cancer and HPV positive tumors.

9. 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.

10. 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).

11. 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).

12. 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.

13. Presence of active gastrointestinal disease or other condition that will impair
significantly with the absorption, distribution, metabolism, or excretion of CS3002.

14. Uncontrolled intercurrent illness including, but not limited to, known ongoing or
active infection, including HIV, active hepatitis B or C.

15. 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.

16. 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).

17. Known or suspected active alcohol or drug abuse.

18. 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.

19. Females who are pregnant or lactating.

For more information regarding trial participation, please contact at
cstonera@cstonepharma.com

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Heidelberg
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3199 - Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CStone Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT04162301
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yaling Huang
Address 0 0
CStone Pharma
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wendie Yuan
Address 0 0
Country 0 0
Phone 0 0
+86 21 61097678
Fax 0 0
Email 0 0
cstonera@cstonepharma.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04162301