NCT02330367|UnknownPhase 1

Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010 in Patients With EGFR T790M Positive NSCLC

Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of AC0010 in Patients With EGFR T790M Positive Advanced Non Small Cell Lung Cancer Who Progressed on Prior Therapy With EGFR TKIs

Hangzhou ACEA Pharmaceutical Research Co., Ltd.ClinicalTrials.gov

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1 other identifier

AC201410AVTN02.

Study Type

interventional

Target

368

Locations

1 country

Sites

Timeline

RegisteredJan 2015

StartedJan 2015

CompletionMar 2023

Brief Summary

AC0010 is a novel, potent, small molecule irreversible tyrosine kinase inhibitor (TKI) that selectively targets mutant forms of the epidermal growth factor receptor (EGFR) while sparing wild-type (WT) EGFR. The purpose of the study is to evaluate the pharmacokinetic (PK) and safety profile of oral AC0010; to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of oral AC0010; to assess the safety and efficacy of AC0010 in previously treated mutant EGFR in NSCLC patients with EGFR T790M mutation.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

368

participants targeted

Target at P75+ for phase_1

Timeline

Completed

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach

1 country

17 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8.2 years study duration

First Submitted

Initial submission to the registry

December 31, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed

Same day until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed

7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed

Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

7.9 years

First QC Date

December 31, 2014

Last Update Submit

September 2, 2021

Conditions

Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

ORR(Objective Response Rate)
To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months

Secondary Outcomes (6)

DoR (Duration of Response)
Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
PFS (Progression-free survival)
Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
DCR (Disease control rate)
Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 11 months
OS (Overall survival)
Every 6 weeks from time of first dose until objective disease progression, then every 3 months until death of lost of follow-up, up to approximately 18 months
EORTC QLQ-C30 and LC-13 questionnaire
From screening to the end of survival follow-up, which is assessed though study completion
+1 more secondary outcomes

Study Arms (1)

AC0010

EXPERIMENTAL

Oral AC0010 monotherapy

Drug: AC0010

Interventions

AC0010DRUG

Phase 1: AC0010 will be administered in escalating dosages in a period of 28-day cycles. Phase 2: AC0010 will be administered twice-daily at RP2D.

Also known as: AC0010MA

AC0010

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients of either gender, aged from 18 years older to 75.
Histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC.
At least one measurable disease by CT or MRI, according to RECIST Version 1.1.
Failed to the treatment of EGFRTKI with definite state of T790M, or harbored T790M mutation without the treatment of EGFRTKI.
Offer biopsy sample to central lab if failed or without the treatment of EGFRTKI.
Adequate hematological and physiological functions of heart, lung, liver, and kidney according to definitions given in Appendix D.
Any prior treatment (including chemotherapy, radiotherapy, biotherapy and other clinical medicine) must be completed over 28 days or 5 half-lives from the screening.
ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1.
NSCLC patients with asymptomatic brain metastasis or drug-controllable brain metastasis.
Life expectancy of at least 3 months.
Patients should cooperate with investigator to observe adverse events and efficacy.
Without other anticancer therapy.
Women without pregnancy or breastfeeding.
Adequate function of blood coagulation (INR≤1.5)
Signed consent on an Independent Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.

You may not qualify if:

No pathology confirmation.
HCV positive, active hepatitis B.
History of interstitial lung disease related to prior EGFR inhibitor therapy.
Positive to HIV antibody or other immunodeficiency disease or organ transplantation.
Residue toxicity related to prior therapies \> grade 1.
BUN or Cr \> 1.5 × upper limits of normal.
ALT or AST \> 2.5 × upper limits of normal, total bilirubin\> 1.5 × upper limits of normal.
Fever (temperature\>38℃ or any uncontrolled active infections.
Patients received high-dose glucocorticoid or any other immunosuppression within 1 month.
Any severe or uncontrolled disease, such as mental, neurologic, cardiovascular, respiratory diseases.
Patients with symptomatic and untreated brain metastasis.
Patients with organic heart disease, cardiac insufficiency, \>2 degree heart block, experienced myocardial infarction in 6 months. Abnormal PR, QT, QRS interval (defined as: 12 lead electrocardiogram QT interval correlated to Bazetts (QTcB)\>450ms (male) or \>470ms (female), PR\>240ms, QRS\>110ms).
Patients receiving medication known to prolong QT interval.
Past history of major surgery in 14 days prior to enrollment.
Pregnant or lactating women.
+29 more criteria

Contact the study team to confirm eligibility.