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A Study of NBF-006 in Non-Small Cell Lung,Pancreatic, or Colorectal Cancer

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. Identifier: NCT03819387
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : April 15, 2019
Information provided by (Responsible Party):
Nitto BioPharma, Inc.

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date April 15, 2019
Actual Study Start Date  ICMJE March 18, 2019
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
Number of patients with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Change in the incidence and severity of adverse events related to study treatment from baseline to 4 weeks following last dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03819387 on 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 A Study of NBF-006 in Non-Small Cell Lung,Pancreatic, or Colorectal Cancer
Official Title  ICMJE A Phase I/Ib Open-Label, Multi-Center, Dose-Escalation Study to Investigate the Safety, Pharmacokinetics and Preliminary Efficacy of Intravenous NBF 006 in Patients With Non-Small Cell Lung, Pancreatic, or Colorectal Cancer
Brief Summary This is an open-label, non-controlled study to investigate the safety, efficacy and pharmacokinetics (PK) of NBF-006 in patients with advanced non-small cell lung cancer (NSCLC), pancreatic, or colorectal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer
Intervention  ICMJE Drug: NBF-006
Intravenous infusion, once-weekly x 4 consecutive weeks, every 6 weeks
Study Arms  ICMJE Experimental: NBF-006
Intervention: Drug: NBF-006
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date February 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Part A: Patients with histologically or cytologically confirmed progressive or metastatic NSCLC, pancreatic, or colorectal cancer that have failed standard treatment and for which no other effective treatment is available for that patient.

    Part B: Patients with histologically or cytologically confirmed progressive or metastatic NSCLC with documented KRAS-mutant genotype that have failed standard treatment and have no other effective treatment available.

  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  3. Men and women ≥ 18 years of age.
  4. Patients must have recovered from all acute adverse effects (excluding alopecia) of prior therapies to baseline or ≤ Grade 1 prior to study entry.
  5. Adequate bone marrow function, defined as an absolute neutrophil count (ANC) ≥1.5 x 10^9/L and a platelet count ≥100 x 10^9/L.
  6. Adequate renal function, defined as serum creatinine ≤1.5 X upper limit of normal (ULN) for the institution or calculated creatinine clearance [Cockcroft-Gault method] must be ≥ 60 mL/min/1.73 m^2. If serum creatinine is >1.5 x ULN, then creatinine clearance can be calculated from a 24 hour urine collection.
  7. Adequate hepatic function, defined as total bilirubin ≤ 1.5 mg/dL and alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 X ULN, or ≤ 5 X ULN if known liver metastases.
  8. Female patients of childbearing potential must have a negative serum or urine pregnancy test result at time of pre-treatment screening.
  9. Patients with reproductive potential must agree to use at least one form of barrier contraception prior to study entry and for up to 30 days beyond the last administration of study drug.
  10. Patients must be capable of providing informed consent and must be willing to provide written informed consent prior to the start of any study-specific procedures.
  11. In Part B, all patients must have measurable tumor per RECIST 1.1.

Exclusion Criteria:

  1. Prior chemotherapy, radiation therapy, or investigational therapy within 4 weeks (exception: 6 weeks for nitrosoureas or mitomycin C); or prior non-cytotoxic therapy within 5 drug half-lives (or 4 weeks, whichever is shorter); or monoclonal antibodies within 4 weeks prior to the first dose of study treatment.
  2. Concurrent use of any other investigational agent.
  3. Known or clinically suspected central nervous system (CNS) or leptomeningeal metastases, unless irradiated or treated a minimum of 4 weeks prior to first study treatment and stable without requirement of corticosteroids for > 1 week.
  4. Pregnant or breast feeding. A negative pregnancy test must be documented at baseline for women of childbearing potential. Patients may not breast-feed infants while on this study.
  5. Significant cardiovascular disease or condition, including:

    1. Congestive heart failure (CHF) currently requiring therapy
    2. Need for antiarrhythmic medical therapy for ventricular arrhythmia
    3. Severe conduction disturbance
    4. Angina pectoris requiring therapy
    5. QTc interval > 450 msec (males) or > 470 msec (females) Fridericia's correction Note: QTc values up to 500 ms will be acceptable where patient's medical history e.g. bundle branch block, is known to cause mild QTc prolongation and the condition is well controlled.
    6. History of congenital long QT syndrome or congenital short QT syndrome
    7. Uncontrolled hypertension (per the Investigator's discretion)
    8. Class III or IV cardiovascular disease according to the New York Heart Association's (NYHA) Functional Criteria
    9. Myocardial infarction (MI) within 6 months prior to first study drug administration
  6. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  7. Psychiatric disorder or altered mental status that would preclude understanding of the informed consent process and/or completion of the necessary studies.
  8. Known allergic reactions to H1/H2 antagonists.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03819387
Other Study ID Numbers  ICMJE NBF-006-001
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 Not Provided
Responsible Party Nitto BioPharma, Inc.
Study Sponsor  ICMJE Nitto BioPharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nitto BioPharma, Inc.
Verification Date April 2019

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