Trial Search Results

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

The main purpose of this study is to determine the most effective dose and side effects of AC0010MA given to patients with NSCLC with Previously Treated EGFRmut and Acquired T790M Mutation whose disease has not responded to (gotten better with) previous types of treatment or responded at first but then relapsed (progressed or got worse). The study will collect information about side effects from taking AC0010MA, the highest dose (amount) that can be taken without serious or hard to treat side effects, how AC0010MA is distributed in the body and whether AC0010MA is useful in treating patients with NSCLC with Previously Treated EGFRmut and Acquired T790M Mutation.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

ACEA Therapeutics, Inc.

Intervention(s):

  • Drug: AC0010MA

Phase:

Phase 1

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Lisa Zhou
650-736-4112
Not Recruiting