A Study to Evaluating the Pharmacokinetics, Safety, and E... | NCT04691141

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was stopped early because the sponsor decided to change the study-drug development strategy

Expanded Access Info

Start Date

Feb 23, 2021Actual

Primary Completion Date

Sep 19, 2023Actual

Completion Date

Sep 19, 2023Actual

First Submitted Date

Dec 23, 2020

First Submission Date that Met QC Criteria

Dec 29, 2020

First Posted Date

Dec 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2024

Last Update Posted Date

Apr 17, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy. In Phase I: approximately 15 to 21 subjects and Phase II: approximately 44 subjects; approximately 59 to 65 subjects will be enrolled totally in this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ATG-016	Experimental	5 mg QD×Days 1-5/week will be the initial dose of this study.	Drug: ATG-016

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ATG-016	Drug	59 patients enrolled will be treated with ATG-016, orally, each 4 week (28-day) a cycle	ATG-016

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MTD in Phase I	MTD will be evaluated using the NCI-CTCAE, Version 5.0	16 months
RP2D in Phase I	RP2D will be determined under the guidance of the SRC.	16 months
AEs/SAEs	Toxicity will be graded according to the NCI CTCAE, Version 5.0.	25 months
ORR in Phase II	Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)	25 months

Secondary Outcomes

Measure	Description	Time Frame
Disease Control Rate (DCR) in Phase I/II	DCR (CR + PR + mCR + HI + SD)	12 months
Duration of Response (DOR) in Phase I/II	To evaluate duration of response

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
≥18 years of age, males or females.
Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
A life expectancy longer than 3 months in the opinion of the investigator at the screening.
Male subjects (Including those who have received vasectomy) must agree to use condoms during sex with a woman of childbearing age and have no plans to impregnate the woman throughout the study and for 3 months following the last dose after the date of signing the ICF.

Exclusion Criteria:

History of central nervous system (CNS) involvement.
Toxicity from prior antitumor therapy did not return to Grade 1 or baseline (Except for alopecia, neutropenia, anemia, and thrombocytopenia. For neutrophils, hemoglobin, and platelets, please follow Exclusion Criteria No. 5).
History of human immunodeficiency virus (HIV) infection.
History of severe bleeding disorder, such as hemophilia A, hemophilia B, and vascular hemophilia.
History of allogeneic stem-cell transplantation.
Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.
Pregnant or lactating women.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Provincal People's Hospital		Guangzhou	Guangdong	510000	China
Henan Cancer Hospital

ID	Term
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases