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Trial record 1 of 1 for:    NCT02448251
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Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer

This study is currently recruiting participants.
Verified July 2016 by ACEA Biosciences, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02448251
First Posted: May 19, 2015
Last Update Posted: July 27, 2016
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.
Information provided by (Responsible Party):
ACEA Biosciences, Inc.
  Purpose
AC0010MA is a new, irreversible, Epidermal Growth Factor Receptor (EGFR) mutation selective Tyrosine Kinase Inhibitor. Aim at local advanced or metastatic non-small cell lung cancer patients with EGFR mutation or T790M drug-resistant mutation. The molecular mechanism: by irreversible combining the EGFR-RTKs ATP binding site of cell, selectively suppress the activities of EGFR tyrosine kinase phosphorylation, block the signal transduction pathway of EGFR and inhibit the function of ras/raf/MAPK downstream, thus block the tumor cell growth by EGFR induction, and promotes apoptosis. AC0010MA Maleate Capsules has three characters: 1. Irreversible binding to EGFR; 2. Efficiently suppresses the tumor cell with EGFR mutant and has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR T790M drug-resistant mutation.

Condition Intervention Phase
Non Small Cell Lung Cancer Drug: AC0010MA Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Multicenter, Open-label Safety, Pharmacokinetic and Preliminary Efficacy Study of Wild-type Sparing EGFR Inhibitor, AC0010MA, in Adult Patients With Previously Treated EGFRmut and Acquired T790M Mutation Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by ACEA Biosciences, Inc.:

Primary Outcome Measures:
  • Safety and tolerability, and the maximum tolerated dose (MTD) of AC0010MA determined by incidence of dose limiting toxicity (DLT) [ Time Frame: within the first 28 days of treatment. ]
    To determine the safety and tolerability and to establish the maximum tolerated dose (MTD) of AC0010MA by incidence of dose limiting toxicity (DLT), defined as Grade 3 or 4 adverse events (AEs) and clinical lab abnormalities occurring within the first 28 days of treatment.

  • Plasma concentrations and pharmacokinetic parameters of single dose or multiple doses of AC0010MA [ Time Frame: Blood samples will be collected at pre-treatment, and at 0.5, 1, 2, 3, 4, 6, 8, 12, and 24h post-treatment on Days 1, 8, and 28 in the first treatment cycle (QD and BID) in Phase I ]

Secondary Outcome Measures:
  • Evaluation of tumor response and duration of response of AC0010MA ((objective response rate, ORR) [ Time Frame: within the time frame of every 8 weeks (2 cycles) for up to 3 years ]

    To characterize tumor response (objective response rate, ORR) and duration of response of AC0010MA as a criterion for further development of AC0010MA in this patient population.

    Following Phase I, a protocol amendment will be submitted to the IND to specify the selected dose and dose justification to be used in Phase II.



Estimated Enrollment: 100
Study Start Date: May 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single dose per day (QD)
Phase I Arm 1: AC0010MA orally taking once daily, starting from 100 mg per day.
Drug: AC0010MA
Following Phase I, a protocol amendment will be submitted to the IND to specify the selected dose and dose justification to be used in Phase II.
Experimental: two doses per day (BID)
Phase I Arm 2: AC0010MA orally taking twice daily, starting from 200 mg per day (100 mg BID). Arm 2 will be initiated once the drug plasma t1/2 is 10 hours or below in the first dose cohort (100 mg QD).
Drug: AC0010MA
Following Phase I, a protocol amendment will be submitted to the IND to specify the selected dose and dose justification to be used in Phase II.

Detailed Description:
A Phase I/II, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Ascending Doses of AC0010MA in Patients with Previously Treated EGFRmut and Acquired T790M Mutation Non-Small Cell Lung Cancer.
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients of either gender, aged 18 years or older.
  • Histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC.
  • NSCLC patients do not have to have brain metastasis.
  • At least one measurable disease by CT or MRI, according to RECIST Version 1.1.
  • Documented evidence of any activating EGFR mutation in the tumor tissue determined by either sequencing or PCR-based technique.
  • Have undergone or are able to undergo a biopsy of either primary or metastatic tumor tissue within 28 days of dosing of AC0010MA, and have tissue available to send to central lab for further genetic profiling especially the status of T790M.
  • Life expectancy of at least 3 months.
  • ECOG performance status of 0 to 1.
  • Adequate hematological and physiological functions of heart, lung, liver, and kidney, according to definitions given in Appendix D.
  • Disease progression under at least one treatment with current marketed EGFR TKI therapy for at least 30 days (e.g. erlotinib, or gefitinib, or afatinib). Intervening treatment with chemotherapy after most recent EGFR TKI therapy is permissible with a washout period of 14 days. The washout period for an EGFR TKI (erlotinib, or gefitinib) is at a minimum of 3 days. The washout period for an irreversible EGFR inhibitor (afatinib) is at a minimum of 14 days.
  • T790M positive patients treated with AZD9291 or CO1686 and who are not tolerant to the AEs of the treatment. The minimum washout period for AZD9291 and CO1686 is 14 days.
  • Any toxicity related to prior EGFR inhibitor treatment must have been resolved to Grade 1 or less.
  • Signed consent on an Independent Ethics Committee-approved Informed Consent Form prior to any study-specific evaluation.

Exclusion Criteria:

  • History of interstitial lung disease related to prior EGFR inhibitor therapy.
  • Symptomatic brain metastases or uncontrollable or unstable brain metastasis.
  • Positive to HCV or HIV antibody.
  • Treatment with prohibited medications (e.g., concurrent anticancer therapy including other chemotherapy, radiation, hormonal, or immunotherapy) ≤14 days prior to treatment with AC0010MA.
  • Clinically significant abnormal 12-lead ECG, QT interval corrected using Fridericia's method (QTcF) >450 msec (males) or >470 msec (females).
  • Family history of long QT syndrome.
  • Implantable pacemaker or implantable cardioverter defibrillator.
  • Treatment with any Category 1 and 2 drugs.
  • Those previously treated with AZD9291 or CO1686 and had disease progression.
  • Non-study related surgical procedures ≤14 days prior to administration of AC0010MA. In all cases, the patient must be sufficiently recovered and stable before AC0010MA administration.
  • Females who are pregnant or breastfeeding.
  • Refusal to use adequate contraception for fertile patients (females and males) for 6 months after the last dose of AC0010MA.
  • Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study (e.g., substance abuse, uncontrolled psychiatric condition, uncontrolled intercurrent illness including active infection, arterial thrombosis, and symptomatic pulmonary embolism).
  • Any other reasons for the investigator to consider the patient should not participate in the study.
  • Patients receiving treatment with medications that are known to be strong inhibitors or inducers of CYP3A4/5.
  Contacts and Locations
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): NCT02448251


Contacts
Contact: Zhongling Feng, MD, PhD 858-724-0928 ext 3088 zfeng@aceabio.com

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
United States, Colorado
University of Colorado Cancer Center Recruiting
Aurora, Colorado, United States, 80045
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
United States, Michigan
Karmanos Cancer Institute/Wayne State University Recruiting
Detroit, Michigan, United States, 48201
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
ACEA Biosciences, Inc.
Investigators
Study Director: Vali A. Papadimitrakopoulou, MD MD Anderson Cancer Center, Houston, TX, USA
Principal Investigator: Suresh S. Ramalingam, MD Emory University School of Medicine, Atlanta, GA, USA
Principal Investigator: Shirish . Gadgeel, MD Karmanos Cancer Institute/Wayne State University, Detroit, MI, USA
Principal Investigator: Ross Camidge, MD, PhD University of Colorado Cancer Center, Aurora, CO, USA
Principal Investigator: Karen L Reckamp, MD City of Hope Comprehensive Cancer Center, Duarte, CA, USA
  More Information

Responsible Party: ACEA Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02448251     History of Changes
Other Study ID Numbers: AC00102014-101
First Submitted: May 12, 2015
First Posted: May 19, 2015
Last Update Posted: July 27, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms