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Phase 2 Study of Tarloxotinib in Patients With NSCLC Harboring EGFR Exon 20 Insertion or HER2-activating Mutations (RAIN)

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ClinicalTrials.gov Identifier: NCT03805841
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : April 3, 2019
Sponsor:
Information provided by (Responsible Party):
Rain Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE January 11, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date April 3, 2019
Actual Study Start Date  ICMJE March 13, 2019
Estimated Primary Completion Date March 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
ORR [ Time Frame: through study completion, an average of 10 months ]
Objective Response Rate (number of subjects with PR or CR)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03805841 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study of Tarloxotinib in Patients With NSCLC Harboring EGFR Exon 20 Insertion or HER2-activating Mutations
Official Title  ICMJE A Phase 2 Study to Evaluate the Objective Response to Tarloxotinib Administered Intravenously to Patients With Non Small Cell Lung Cancer That Harbors Either EGFR Exon 20 Insertion or a HER2-Activating Mutation
Brief Summary Open-label, Phase 2, single treatment arm, 2 cohorts
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • NSCLC, Stage IV
  • NSCLC Stage IIIB
  • NSCLC, Stage IIIC
  • NSCLC, Recurrent
  • EGFR Exon 20 Insertion Mutation
  • HER2-activating Mutation
Intervention  ICMJE Drug: tarloxotinib bromide
weekly intravenous infusion
Other Names:
  • Tarlox
  • tarloxotinib
Study Arms  ICMJE Experimental: Active
tarloxotinib bromide
Intervention: Drug: tarloxotinib bromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 15, 2021
Estimated Primary Completion Date March 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Histologically and/or cytologically confirmed primary diagnosis of NSCLC, Stage IV, Stage IIIB or IIIC not amenable to definitive curative intent therapy, or recurrent disease after prior diagnosis of Stage I-III disease
  • Progression of disease on or after a platinum-based chemotherapy regimen
  • EGFR exon 20 insertion mutation (Cohort A) or HER2 activating mutation (Cohort B)
  • Measurable disease according to RECIST v.1.1
  • ECOG performance status of 0 or 1
  • Serum creatinine ≤ 1.5 x ULN (or calculated creatinine clearance ≥ 60 mL/min using Cockcroft Gault equation)
  • Total bilirubin: ≤ 1.5 x ULN or ≤ 3 x ULN in the presence of liver metastases
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or ≤ 5 x ULN, in the presence of liver metastases
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/μL
  • Hemoglobin ≥ 9 g/dL or 5.6 mmol/L
  • Platelet count ≥ 100,000/μL
  • No evidence of second or third degree atrioventricular block
  • No clinically significant arrhythmia (i.e.; pauses of > 4 seconds, VT of any duration, SVT > 4 beats/minute)
  • QRS interval ≤ 110 ms
  • QTcF interval of < 450 ms
  • PR interval ≤ 200 ms
  • Adequate pretreatment tumor sample (125 µm of FFPE block or at least 8 prepared slides)

Key Exclusion Criteria:

  • Another known activating oncogene driver mutation
  • Previously received anti EGFR or anti HER2 tyrosine kinase inhibitors
  • Previously received anti EGFR or anti HER2 monoclonal antibodies or EGFR or HER2 antibody drug conjugates
  • Investigational therapy administered within the 28 days or 5 half lives
  • Chemotherapy or radiation within 14 days prior to Cycle 1 Day 1
  • Immunotherapy within 21 days
  • Clinically active or symptomatic interstitial lung disease (ILD) or interstitial pneumonitis, or a history of clinically significant ILD or radiation pneumonitis
  • Untreated and/or symptomatic CNS malignancies (primary or metastatic);
  • Receiving medication that prolongs QT interval, with a risk of causing Torsade de Pointes (TdP)
  • Personal or familial history of Long QT Syndrome
  • NYHA class III or IV or LVEF < 55%
  • Myocardial infarction, severe or unstable angina within 6 months
  • History of TdP, ventricular arrhythmia
  • Significant thrombotic or embolic events within 3 months
  • Uncontrolled or severe cardiovascular disease
  • Concurrent malignancy expected to require treatment within 2 years or interfere with study outcomes
  • History of severe allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition as tarloxotinib
  • Known HIV infection or active Hepatitis B or C
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Thomas Tremblay, RN BSN +1 (510) 250-3705 ttremblay@rainthera.com
Listed Location Countries  ICMJE Canada,   Hong Kong,   United States
Removed Location Countries Singapore
 
Administrative Information
NCT Number  ICMJE NCT03805841
Other Study ID Numbers  ICMJE RAIN-701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No Plan
Responsible Party Rain Therapeutics Inc.
Study Sponsor  ICMJE Rain Therapeutics Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen V Liu, MD Georgetown University
PRS Account Rain Therapeutics Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP