Clinical Trials /

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

NCT03819387

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of NBF-006 in Non-Small Cell Lung,Pancreatic, or Colorectal Cancer
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: NBF-006-001
  • NCT ID: NCT03819387

Conditions

  • Non-Small Cell Lung Cancer
  • Pancreatic Cancer
  • Colorectal Cancer

Interventions

DrugSynonymsArms
NBF-006NBF-006

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
NBF-006Experimental
  • NBF-006

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Nitto BioPharma, Inc.

Last Updated

September 10, 2019