Study of MAX-40279 in Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)

NCT04187495 | Unknown Phase 1

• 1 other identifier: MAX-40279-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-40279-01 in patients with Relapsed or Refractory AML.

Conditions

AML

Outcome Measures

Primary Outcomes (3)

• Adverse events (AEs)

  Incidence of treatment-related AEs

  8 weeks

• Maximum tolerated dose (MTD）

  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.

  4 weeks

• Phase II dose (RP2D)

  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.

  4 weeks

Secondary Outcomes (5)

• Tmax

  Approximately 4 weeks

• Cmax

  Approximately 4 weeks

• AUC

  Approximately 4 weeks

• t1/2

  Approximately 4 weeks

• Objective response rate (ORR)

  1 months (anticipated)

Study Arms (1)

MAX-40279-01

EXPERIMENTAL

Drug: MAX-40279-01

Interventions

MAX-40279-01 DRUG

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. For each dose level, a single dose of MAX-40279-01 will be first administered orally followed by 1 day observation, then continuous treatment will start 4 weeks treatment (per cycle).

MAX-40279-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and/or females over age 18.
• Subject has morphologically documented relapsed or refractoryprimary AML as defined by the World Health Organization (WHO) 2016 criteria for which no established standard therapy is available.
• ECOG performance status of 0 to 2.
• Persistent chronic clinically significant non-hematological toxicities from prior treatment (including chemotherapy, kinase inhibitors, immunotherapy, experimental agents, radiation, HSCT, or surgery) must be Grade ≤ 1.
• Any anti-tumor treatment with radiation therapy, surgery, or immunotherapy wihtin 2 weeks prior to trial entry.
• Life expectancy of at least 3 months.
• Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for six months following the last dose of study drug.

You may not qualify if:

• Disease diagnosis of acute promyelocytic leukemia.
• 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 5 years at the trial entry.
• Laboratory values not within the Protocol-defined range.
• 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.

Sponsors & Collaborators

• Maxinovel Pty., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Central Study Contacts

Hanying Bao, MD,Ph.D

CONTACT

+86-21-51370693; hybao@maxinovel.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: April 16, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 19, 2022

Record last verified: 2022-01

Locations

CN (1)