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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04122339
Registration number
NCT04122339
Ethics application status
Date submitted
29/09/2019
Date registered
10/10/2019
Titles & IDs
Public title
MAX-10181 Given Orally to Patients With Advanced Solid Tumor
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Scientific title
A Phase I Study of MAX-10181 Given Orally to Patients With Advanced Solid Tumor
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Secondary ID [1]
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Maxinovel-10181-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Solid Tumor
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MAX-10181
Experimental: MAX-10181 - tablet
Treatment: Drugs: MAX-10181
Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria.
Part 2: Dose expansion, Recommended doses from Part 1.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adverse events (AEs)
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Assessment method [1]
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Incidence of treatment-related AEs
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Timepoint [1]
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8 weeks
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Primary outcome [2]
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Maximum tolerated dose (MTD)
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Assessment method [2]
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MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of multiple dosing.
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Timepoint [2]
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4 weeks
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Primary outcome [3]
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Phase II dose (RP2D)
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Assessment method [3]
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The number and proportion of patients experiencing at least 1 dose-limiting toxicity (DLT) will be used as the primary measure to evaluate the RP2D of MAX-10181.
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Timepoint [3]
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4 weeks
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Secondary outcome [1]
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Tmax
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Assessment method [1]
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Time to maximum plasma concentration
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Timepoint [1]
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Approximately 4 weeks
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Secondary outcome [2]
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Cmax
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Assessment method [2]
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Time to maximum plasma concentration
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Timepoint [2]
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Approximately 4 weeks
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Secondary outcome [3]
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AUC
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Assessment method [3]
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Area under the time-concentration curve
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Timepoint [3]
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Approximately 4 weeks
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Secondary outcome [4]
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t1/2
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Assessment method [4]
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Observed terminal half-life
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Timepoint [4]
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Approximately 4 weeks
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Secondary outcome [5]
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Objective response rate (ORR)
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Assessment method [5]
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The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
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Timepoint [5]
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12 months (anticipated)
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Eligibility
Key inclusion criteria
* Males and/or females over age 18.
* Histologically or cytologically confirmed advanced or metastatic solid tumor for which no established standard therapy is available.
* At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
* Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
* Life expectancy of at least 3 months.
* Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Laboratory values not within the Protocol-defined range.
* Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
* Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
* Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
* Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
* Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
* Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis.
* History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
* Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2022
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Linear Clinical Research - Nedlands
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Recruitment postcode(s) [1]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Maxinovel Pty., Ltd.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.
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Trial website
https://clinicaltrials.gov/study/NCT04122339
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Hanying bao, MD,Ph.D
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Address
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Country
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Phone
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+86-021-51370693
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04122339