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Advanced CancerPhase 1NCT03730142

A Study of WXFL10030390 in Patients With Advanced Solid Tumors or Lymphoma

A Phase 1 study testing WXFL10030390 in people with Advanced Cancer, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Cancer
What is being tested?
WXFL10030390
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteChina
Study dates
25 Oct 2018to 25 Jul 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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

Who cannot join

  • 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
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai East Hospital

    Shanghai

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

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.

Conditions
Advanced Cancer
Being tested
WXFL10030390
Keywords
phosphoinositide-3 kinase (PI3K), mammalian target of rapamycin (mTOR)
Medical subject headings
Hereditary Sensory and Autonomic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WXFL10030390Drug

    Also called WX390

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

Study groups in NCT03730142
Study groupRoleWhat they receive
WXFL10030390 tabletExperimentalWXFL10030390 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)
Receives: Drug: WXFL10030390

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0

    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.

    Measured: From first dose to within 30 days after the last dose

Secondary outcomes (7)

  1. Maximum plasma concentration (Cmax)

    Cmax will be determined for an oral administration of WXFL10030390 tablets.

    Measured: 28 days

  2. Time to reach plasma Cmax (tmax)

    tmax will be determined for an oral administration of WXFL10030390 tablets.

    Measured: 28 days

  3. Area under the plasma concentration-time curve (AUC)

    AUC will be determined for an oral administration of WXFL10030390 tablets.

    Measured: 28 days

  4. Terminal elimination half-life (t½)

    t½ will be determined for an oral administration of WXFL10030390 tablets.

    Measured: 28 days

  5. Recommended study Phase II dose (RP2D)

    The recommended phase 2 dose (RP2D) of WXFL10030390 will be determined based on pharmacokinetics, safety and tolerability, as well as preliminary efficacy.

    Measured: Up to 1 year

  6. Disease control rate

    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

    Measured: From first dose to within 30 days after the last dose

  7. Objective response rate

    Defined as complete response [CR] + partial response [PR]) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) or Lugano 2014 criteria

    Measured: From first dose to within 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2018
  2. Study start25 Oct 2018
  3. Primary completion25 Jul 2020
  4. Study completion25 Jul 2020

Resources

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
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03730142
Sponsor's protocol ID
JYA0101
Status last verified
Apr 2023
First submitted
21 Oct 2018
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing WXFL10030390 in people with Advanced Cancer, run by Shanghai Jiatan Pharmatech Co., Ltd at 1 site in China.

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 8 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 18 Apr 2023. 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 China. 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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03730142.

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 18 Apr 2023.

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