Clinical Trials /

First-in-Human, Dose Finding, Open Label Phase 1A-1B Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

NCT03199586

Description:

Phase 1 A: First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X 28 days followed by a 14 day rest period.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: First-in-Human, Dose Finding, Open Label Phase 1A-1B Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies
  • Official Title: First-in-Human, Dose Finding, Open Label Phase 1A-1B Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

Clinical Trial IDs

  • ORG STUDY ID: NP-G2-044-P1-01
  • NCT ID: NCT03199586

Conditions

  • Breast Cancer
  • Pancreas Cancer
  • Prostate Cancer
  • Lung Cancer
  • Colon Cancer
  • Esophagus Cancer
  • Liver Cancer
  • Ovary Cancer
  • Advanced or Metastatic Treatment-refractory Solid Tumor Malignancies

Interventions

DrugSynonymsArms
NP-G2-044NP-G2-044

Purpose

Phase 1 A: First-in-human phase 1 study to determine safety of NP-G2-044 when given orally on a daily X 28 days followed by a 14 day rest period.

Trial Arms

NameTypeDescriptionInterventions
NP-G2-044Experimentalcapsule
  • NP-G2-044

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent and mental capability to understand the informed consent

          2. Male or female patients > 18 years of age

          3. Histologically or cytologically documented locally advanced or metastatic solid tumor
             malignancies either treatment-refractory or otherwise ineligible for treatment with
             standard-of-care agents/regimens

          4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

          5. Evaluable or measurable disease per RECIST v1.1

          6. Life expectancy > 3 months

          7. ECG without evidence of clinically meaningful conduction abnormalities or active
             ischemia as determined by the Investigator

          8. Acceptable organ and marrow function as defined below:

               -  Absolute neutrophil count > 1,500 cells/μL

               -  Hemoglobin ≥ 9.0 g/dL

               -  Platelets > 100,000 cells/μL

               -  Total bilirubin ≤ 1.5 mg/dL

               -  Albumin ≥ 3 g/dL

               -  Aspartate aminotransferase (AST)/alanine transaminase (ALT)/alkaline phosphatase
                  (ALP)/Gamm-glutamyl transferase (GGT) ≤ 2.5 times ULN. For Phase 1A only, if
                  liver metastases are present, AST/ALT/ALP < 5 times ULN

               -  Serum creatinine < 1.5 mg./dL and a measured creatinine clearance ≥ 60 mL/min

               -  Prothrombin time (PT)/partial thromboplastin time (PTT) ≤ 1.5 times ULN

          9. Women of child-bearing potential (defined as a female who has experienced menarche and
             who has not undergone successful surgical sterilization (hysterectomy, bilateral
             salpingectomy, or bilateral oophorectomy) or is not postmenopausal (defined as
             amenorrhea for at least 12 consecutive months with an appropriate clinical profile at
             the appropriate age, e.g., greater than 45 years) must have a negative serum pregnancy
             test prior to first dose of study drug.

         10. Male and female patients with reproductive potential must agree to use adequate
             contraceptive precautions throughout the study.

        Exclusion Criteria:

          1. Chemotherapy, radiotherapy or other anti-cancer treatment within 4 weeks or 5
             half-lives (whichever is shorter) (6 weeks for nitrosoureas or mitomycin C) of the
             first dose of study drug or patients who in opinion of Investigator have not recovered
             from AEs due to agents administered greater than 4 weeks earlier (prior immunotherapy
             is allowed)

          2. Participation in any other clinical investigation using an experimental drug within 4
             weeks of first dose of study drug

          3. Failure to recover to ≤ grade 1 toxicity (except grade 1-2 alopecia or neuropathy)
             associated with previous chemotherapy, radiotherapy, biologic, hormone or prior
             investigational therapy

          4. Known untreated brain metastases or treated brain metastases that have not been
             radiographically and clinically stable (i.e. not requiring steroids) ≥ 4 weeks prior
             to study enrollment

          5. Baseline prolongation of QT/QTc interval (QTc interval > 470 msec in women and >450
             msec in men)

          6. Uncontrolled intercurrent illness (including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations) that in opinion of Investigator
             would limit compliance with study requirements

          7. Women who are pregnant or breastfeeding

          8. Prior allogenic hematopoietic stem cell transplant or allogenic bone marrow transplant
             or prior solid organ transplant or current use of immuno suppression drugs or
             anti-transplant rejection drugs

          9. Prior history of clinically significant gastrointestinal bleeding, intestinal
             obstruction or gastrointestinal perforation within 6 months of study enrollment

         10. Sponsor reserves right to exclude any patient from the study on basis of pre-study
             medical histories, physical examination findings, clinical laboratory results, prior
             medications, or other entrance criteria
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment related adverse events
Time Frame:24 months
Safety Issue:
Description:as assessed by CTCAE V4.03

Secondary Outcome Measures

Measure:Anti tumor activity
Time Frame:24 months.
Safety Issue:
Description:Resist 1.1

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novita Pharmaceuticals, Inc.

Trial Keywords

  • Advanced or metastatic treatment-refractory solid tumor malignancies

Last Updated

November 13, 2019