- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03730142
A Study of WXFL10030390 in Patients With Advanced Solid Tumors or Lymphoma
A Phase Ⅰ Study of PI3K/mTOR Dual Inhibitor WXFL10030390 to Evaluate the Safety, Tolerability and Pharmacokinetics in Patients With Advanced Solid Tumors or Lymphoma
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
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Shanghai, China
- Shanghai East Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥18 and ≤75 years of age
- Histological or cytological confirmed advanced solid tumor or lymphoma, standard regimen failed or no standard regimen available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of more than 3 months
- At least one measurable lesion according to RECIST 1.1 or Lugano 2014
- Adequate organic function: Absolute neutrophil count (ANC) ≥2.0×109/L,PLT≥100×109/L,Hb≥9g/L hepatic function:TBIL≤1.5×upper limit of normal (ULN),Alanine aminotransferase (ALT) ≤2.5×ULN,aspartate aminotransferase (AST) ≤2.5×ULN; renal function:Cr≤1.5×ULN and>50ml/min; coagulation function: APTT≤1.5 ×ULN,PT≤1.5 ×ULN, INR≤1.5 ×ULN; GLU<7mmol/L and HbA1C<7%; TG≤1.5×ULN,CHOL≤1.5×ULN
- Subjects who have the fertility should agree to use reliable contraceptive methods during this study and subsequently at least 12 weeks after the last administration; for female subjects, the blood pregnancy test should be negative within 7 days prior to the enrollment
- Signed and dated informed consent
Exclusion Criteria:
- Anti-cancer therapy within 4 weeks prior to the initiation of investigational treatment
- Surgery within 4 weeks prior to the initiation of study treatment
- Use of strong inducers or inhibitors of CYP3A4 within 1 weeks before the first dose of study treatment. See Appendix 5 for a list of such medications
- Received corticosteroids treatment or other immunodepressant within 2 weeks before the first dose of study treatment
- Toxicity from a previous anti-tumor treatment that does not return to Grade 0 or 1 (except for alopecia)
- Patients with clinical symptomatic brain metastases, spinal compression, meningitis carcinomatosa or other evidence that shows uncontrolled brain or spinal metastases
- Previous treatment with PI3K/mTOR inhibitors
- Patients who once or being suffer Interstitial lung disease
- Evidence of ongoing or active infection
- History of human immunodeficiency virus (HIV) infection
- History of hepatitis B or C infection
- Clinically significant cardiovascular disease, including but not limited to acute coronary syndrome, congestive heart-failure, cerebral stroke within 6 months prior to enrollment, New York Heart Association Class ≥II cardiac functional grading or left ventricular ejection fraction (LVEF) < 50%
- Inability to take medication orally
- Severe gastrointestinal disease leading to diarrhea
- Diabetics receiving insulin treatment
- Patients with active autoimmune disease (including systemic lupus erythematosus, rheumatoid arthritis, nodular vasculitis)
- Abuse of alcohol or drugs
- People with cognitive and psychological abnormality or with low compliance
- Pregnant or lactating women
- Researchers believe that subjects may not be able to complete the study or may not be able to comply with the requirements of this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: WXFL10030390 tablet
WXFL10030390 continuous oral dosing (0.1 mg once a day) WXFL10030390 continuous oral dosing (0.2 mg once a day) WXFL10030390 continuous oral dosing (0.4 mg once a day) WXFL10030390 continuous oral dosing (0.7 mg once a day) WXFL10030390 continuous oral dosing (1.1 mg once a day) WXFL10030390 continuous oral dosing (1.4 mg once a day) WXFL10030390 continuous oral dosing (1.7 mg once a day) |
WXFL10030390 is a tablet in the form of 0.1mg and 0.5mg, oral, once a day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time Frame: From first dose to within 30 days after the last dose
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The safety and tolerability of WXFL10030390 will be evaluated based on adverse events data.
Other safety parameters include physical examination, clinical laboratory tests including coagulation function, renal function, hepatic function, blood glucose and blood lipid.
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From first dose to within 30 days after the last dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum plasma concentration (Cmax)
Time Frame: 28 days
|
Cmax will be determined for an oral administration of WXFL10030390 tablets.
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28 days
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Time to reach plasma Cmax (tmax)
Time Frame: 28 days
|
tmax will be determined for an oral administration of WXFL10030390 tablets.
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28 days
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Area under the plasma concentration-time curve (AUC)
Time Frame: 28 days
|
AUC will be determined for an oral administration of WXFL10030390 tablets.
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28 days
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Terminal elimination half-life (t½)
Time Frame: 28 days
|
t½ will be determined for an oral administration of WXFL10030390 tablets.
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28 days
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Recommended study Phase II dose (RP2D)
Time Frame: Up to 1 year
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The recommended phase 2 dose (RP2D) of WXFL10030390 will be determined based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.
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Up to 1 year
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Disease control rate
Time Frame: From first dose to within 30 days after the last dose
|
The sum of complete responses (CR) + partial responses (PR) + stable disease (SD) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) or Lugano 2014 criteria
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From first dose to within 30 days after the last dose
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Objective response rate
Time Frame: From first dose to within 30 days after the last dose
|
Defined as complete response [CR] + partial response [PR]) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) or Lugano 2014 criteria
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From first dose to within 30 days after the last dose
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- JYA0101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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