Trial | NCT03730142  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    82
WXFL10030390 (WX390) is a novel oral small molecular that inhibits phosphoinositide-3 kinase (PI3K) and mammalian target of rapamycin (mTOR) and has demonstrated potent inhibitory effects on multiple human tumor xenografts. The first-in-human study is conducted to assess the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of WX390 at single dose and multiple doses.
This study will be an open-lable, phase Ⅰ study and will evaluate the safety and pharmacokinetics of WX390 after a single administration followed by a 28-day continuous course of therapy; evaluate the safety and preliminary efficacy in an open-lable administration of WX390 at the MTD.
Study Started
Oct 25
2018
Primary Completion
Jul 25
2020
Study Completion
Jul 25
2020
Last Update
Apr 18
2023

Drug WXFL10030390

WXFL10030390 is a tablet in the form of 0.1mg and 0.5mg, oral, once a day.

  • Other names: WX390

WXFL10030390 tablet Experimental

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)

Criteria 

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
No Results Posted