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Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

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ClinicalTrials.gov Identifier: NCT03199586
Recruitment Status : Completed
First Posted : June 27, 2017
Last Update Posted : December 22, 2020
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
Novita Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Pancreas Cancer Prostate Cancer Lung Cancer Colon Cancer Esophagus Cancer Liver Cancer Ovary Cancer Advanced or Metastatic Treatment-refractory Solid Tumor Malignancies Drug: NP-G2-044 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : May 7, 2020
Actual Study Completion Date : May 7, 2020


Arm Intervention/treatment
Experimental: NP-G2-044
capsule
Drug: NP-G2-044
capsule




Primary Outcome Measures :
  1. Establish the safe recommended phase 2 dose [ Time Frame: 24 months ]
    Treatment related adverse events assessed by CTCAE V4.03


Secondary Outcome Measures :
  1. Identify and characterize preliminary anti tumor activity [ Time Frame: 24 months ]
    Anti tumor activity assessed using RECIST 1.1

  2. Characterize the pharmacokinetics of NP-G2-044 [ Time Frame: 24 months ]
    Drug exposure assessed by area under the curve (AUC)

  3. Tmax [ Time Frame: 24 months ]
    Time to peak plasma concentration

  4. Cmax [ Time Frame: 24 months ]
    Peak plasma concentration



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199586


Locations
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United States, Arizona
HonorHealth Research Institute
Scottsdale, Arizona, United States, 85258
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
United States, New York
Memorial Sloan Kettering Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Novita Pharmaceuticals, Inc.
Translational Drug Development
Investigators
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Study Director: Jillian Zhang, Ph.D. Novita Pharmaceuticals
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Responsible Party: Novita Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03199586    
Other Study ID Numbers: NP-G2-044-P1-01
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novita Pharmaceuticals, Inc.:
Advanced or metastatic treatment-refractory solid tumor malignancies
Additional relevant MeSH terms:
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Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Ovarian Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Head and Neck Neoplasms
Esophageal Diseases
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Gonadal Disorders