Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT02448251 |
Recruitment Status :
Terminated
First Posted : May 19, 2015
Last Update Posted : October 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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Non Small Cell Lung Cancer | Drug: AC0010MA | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, 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) |
Actual Study Start Date : | May 2015 |
Actual Primary Completion Date : | October 2019 |
Actual Study Completion Date : | October 2019 |

Arm | Intervention/treatment |
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Experimental: single dose per day (QD)
Phase I Arm 1: AC0010MA orally taking once daily, starting from 100 mg per day.
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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).
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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. |
- 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.
- 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.
- Maximum plasma concentration (Cmax) 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 ]To evaluate pharmacokinetic parameter of AC0010MA
- Time to Cmax [ 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 ]To evaluate pharmacokinetic parameter of AC0010MA
- Terminal half-life (t1/2) [ 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 ]To evaluate pharmacokinetic parameter of AC0010MA
- Area under the plasma concentration-time curve [ 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 ]To evaluate pharmacokinetic parameter of AC0010MA
- Volume of distribution (V/F) [ 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 ]To evaluate pharmacokinetic parameter of AC0010MA
- Plasma Concentration (CL/F) [ 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 ]To evaluate pharmacokinetic parameter of AC0010MA

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Is male or female, aged 18 years or older at the time of consent; preferably non-Asian.
- Has histologically or cytologically confirmed metastatic, or unresectable locally advanced, recurrent NSCLC.
- Has at least one measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI), according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
- Has documented evidence of an activating EGFR mutation in the tumor tissue determined by either sequencing or PCR-based technique (Part 1).
- For Part 1 only: subjects with a positive T790M mutation are preferred, but not required. Confirmation of T790M mutation status will be determined from an archived tumor tissue sample or fresh tumor tissue sample obtained via biopsy if archived tissue is not available. In Part 2, subjects must have a confirmed, positive T790M EGFR mutation (acquired T790M EGFR mutation or "de novo" T790M EGFR mutation).
- Has a life expectancy of at least 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate hematological and physiological functions.
- Has documented disease progression while receiving at least 30 days of treatment with a currently approved EGFR tyrosine kinase inhibitor (TKI) (e.g., erlotinib, gefitinib or afatinib) with intervening treatment after most recent EGFR TKI therapy (not required for "de novo" T790M EGFR mutation).
- Signed and dated written informed consent obtained prior to any study-specific evaluation.
Exclusion Criteria:
- Has a history of interstitial lung disease related to prior EGFR inhibitor therapy.
- Has an EGFR TKI- related toxicity that has NOT resolved to Grade 1 or less.
- Is test positive for hepatitis C virus (HCV), hepatitis B virus (HBV) or human immunodeficiency virus (HIV) antibody.
- Has received the prohibited therapy (e.g., concurrent anti-cancer therapy including but not limited to: chemotherapy, radiation, hormonal, or immunotherapy) ≤14 days prior to first planned dose of AC0010MA.
- Received prior treatment with AZD9291 (osimertinib) or CO1686 (rociletinib) and experienced disease progression.
- Is a female subject who is pregnant or breastfeeding.
- Female subjects (if of child bearing potential) and male subjects (with a partner of child bearing potential) must use medically acceptable methods of birth control before study entry, for the duration of the study, and for at least 6 months after the last intake of study drug.
- Has a 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, or symptomatic pulmonary embolism).
- Has any other reason(s) for the investigator to consider that the subject should not participate in the study.
- Is receiving treatment with medication(s) that are known to be strong inhibitors or inducers of CYP3A4/5.

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
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010 | |
Stanford University | |
Palo Alto, California, United States, 94304 | |
United States, Georgia | |
Emory University School of Medicine | |
Atlanta, Georgia, United States, 30322 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
France | |
CEPCM - Hopital Timone | |
Marseille, France, 13005 | |
Spain | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Spain, 08035 | |
START-Madrid-FJD | |
Madrid, Spain, 28040 | |
START-Madrid-CIOCC | |
Madrid, Spain, 28050 |
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: | Heather Wakelee, MD | Stanford University, Palo Alto, CA, USA | |
Principal Investigator: | Karen L Reckamp, MD | City of Hope Comprehensive Cancer Center, Duarte, CA, USA |
Responsible Party: | ACEA Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02448251 |
Other Study ID Numbers: |
AC00102014-101 |
First Posted: | May 19, 2015 Key Record Dates |
Last Update Posted: | October 29, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |