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

NCT ID: NCT04187495

Last Updated: 2022-01-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2022-12-01

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.

Detailed Description

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

Conditions

AML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MAX-40279-01

Group Type: EXPERIMENTAL

MAX-40279-01

Intervention Type: 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).

Interventions

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.

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maxinovel Pty., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital, Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hanying Bao, MD,Ph.D

Role: CONTACT

hybao@maxinovel.com

+86-21-51370693

Facility Contacts

Zhen Cai, MD,PhD

Role: primary

caiz@zju.edu.cn

Other Identifiers

MAX-40279-002

Identifier Type: -

Identifier Source: org_study_id