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MAX-40279-01 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04183764
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Maxinovel Pty., Ltd.

Tracking Information
First Submitted Date  ICMJE November 28, 2019
First Posted Date  ICMJE December 3, 2019
Last Update Posted Date December 4, 2019
Actual Study Start Date  ICMJE November 28, 2019
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2019)
  • Maximum tolerated dose (MTD) [ Time Frame: 4 weeks ]
    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.
  • Adverse events (AEs) [ Time Frame: 8 weeks ]
    Incidence of treatment-related AEs
  • Phase II dose (RP2D) [ Time Frame: 4 weeks ]
    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-40279-01.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2019)
  • Tmax [ Time Frame: Approximately 4 weeks ]
    Time to maximum plasma concentration
  • Cmax [ Time Frame: Approximately 4 weeks ]
    Time to maximum plasma concentration
  • Objective response rate (ORR) [ Time Frame: 12 months (anticipated) ]
    The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MAX-40279-01 in Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase Ⅰ Study for Safety, Tolerance, Pharmacokinetic Characteristic of MAX-40279-01 in Patients With Advanced Solid Tumors
Brief Summary This is a multi-center, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with advanced solid tumor.
Detailed Description This is a two-part study comprised of a dose escalation part and a dose expansion part.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor
Intervention  ICMJE Drug: MAX-40279-01

Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria.

Part 2: Dose expansion, Recommended doses from Part 1.

Study Arms  ICMJE Experimental: MAX-40279-01
Intervention: Drug: MAX-40279-01
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 28, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date November 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Exclusion Criteria:

  • Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks (3 weeks for chemotherapy; 6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
  • Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
  • 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 2 years at the trial entry.
  • Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.
  • Laboratory values not within the Protocol-defined range.
  • Cardiac disease , including congestive heart failure, myocardial infarction, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
  • Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hanying bao, MD,Ph.D +86-21-51370693 hybao@maxinovel.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04183764
Other Study ID Numbers  ICMJE MAX-40279-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maxinovel Pty., Ltd.
Study Sponsor  ICMJE Maxinovel Pty., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Maxinovel Pty., Ltd.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP