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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.

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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: MAX-40279-01 Phase 1

Detailed Description:
This is a two-part study comprised of a dose escalation part and a dose expansion part.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ⅰ Study for Safety, Tolerance, Pharmacokinetic Characteristic of MAX-40279-01 in Patients With Advanced Solid Tumors
Actual Study Start Date : November 28, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : February 1, 2021

Arm Intervention/treatment
Experimental: MAX-40279-01 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.





Primary Outcome Measures :
  1. 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.

  2. Adverse events (AEs) [ Time Frame: 8 weeks ]
    Incidence of treatment-related AEs

  3. 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.


Secondary Outcome Measures :
  1. Tmax [ Time Frame: Approximately 4 weeks ]
    Time to maximum plasma concentration

  2. Cmax [ Time Frame: Approximately 4 weeks ]
    Time to maximum plasma concentration

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183764


Contacts
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Contact: Hanying bao, MD,Ph.D +86-21-51370693 hybao@maxinovel.com

Locations
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China, Zhejiang
The First Affiliated Hospital, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Haiping Jiang, MD,PhD    +86-571-87235896      
Sponsors and Collaborators
Maxinovel Pty., Ltd.

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Responsible Party: Maxinovel Pty., Ltd.
ClinicalTrials.gov Identifier: NCT04183764    
Other Study ID Numbers: MAX-40279-003
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maxinovel Pty., Ltd.:
advanced solid tumors
Additional relevant MeSH terms:
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Neoplasms