Safety, Pharmacokinetic and Preliminary Efficacy Study of AC0010MA in Advanced Non Small Cell Lung Cancer

Not Recruiting

Trial ID: NCT02448251

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. Effectively suppresses the tumor cell with EGFR mutant while has no suppression to EGFR wild-type cell; 3. Efficient suppress the tumor cell with EGFR T790M drug-resistant mutation.

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)

Stanford Investigator(s)

Heather Wakelee
Heather Wakelee

Winston Chen and Phyllis Huang Professor

Joel Neal, MD, PhD
Joel Neal, MD, PhD

Associate Professor of Medicine (Oncology)

Kavitha Ramchandran
Kavitha Ramchandran

Clinical Professor, Medicine - Oncology

Millie Das
Millie Das

Clinical Professor, Medicine - Oncology

Eligibility


Inclusion Criteria:

   1. Is male or female, aged 18 years or older at the time of consent; preferably
   non-Asian.

   2. Has histologically or cytologically confirmed metastatic, or unresectable locally
   advanced, recurrent NSCLC.

   3. 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.

   4. Has documented evidence of an activating EGFR mutation in the tumor tissue determined
   by either sequencing or PCR-based technique (Part 1).

   5. 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).

   6. Has a life expectancy of at least 3 months.

   7. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

   8. Has adequate hematological and physiological functions.

   9. 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).

10. Signed and dated written informed consent obtained prior to any study-specific
   evaluation.

Exclusion Criteria:

   1. Has a history of interstitial lung disease related to prior EGFR inhibitor therapy.

   2. Has an EGFR TKI- related toxicity that has NOT resolved to Grade 1 or less.

   3. Is test positive for hepatitis C virus (HCV), hepatitis B virus (HBV) or human
   immunodeficiency virus (HIV) antibody.

   4. 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.

   5. Received prior treatment with AZD9291 (osimertinib) or CO1686 (rociletinib) and
   experienced disease progression.

   6. Is a female subject who is pregnant or breastfeeding.

   7. 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.

   8. 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).

   9. Has any other reason(s) for the investigator to consider that the subject should not
   participate in the study.

10. Is receiving treatment with medication(s) that are known to be strong inhibitors or
   inducers of CYP3A4/5.

Intervention(s):

drug: AC0010MA

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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