Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies
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
1 other identifier
interventional
23
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 breast-cancer
Started Dec 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2017
CompletedFirst Posted
Study publicly available on registry
June 27, 2017
CompletedStudy Start
First participant enrolled
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2020
CompletedJuly 20, 2025
December 1, 2020
2.4 years
June 23, 2017
July 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Establish the safe recommended phase 2 dose
Treatment related adverse events assessed by CTCAE V4.03
24 months
Secondary Outcomes (4)
Identify and characterize preliminary anti tumor activity
24 months
Characterize the pharmacokinetics of NP-G2-044
24 months
Tmax
24 months
Cmax
24 months
Study Arms (1)
NP-G2-044
EXPERIMENTALcapsule
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent and mental capability to understand the informed consent
- Male or female patients \> 18 years of age
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Evaluable or measurable disease per RECIST v1.1
- Life expectancy \> 3 months
- ECG without evidence of clinically meaningful conduction abnormalities or active ischemia as determined by the Investigator
- 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
- +3 more criteria
You may not qualify if:
- 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)
- Participation in any other clinical investigation using an experimental drug within 4 weeks of first dose of study drug
- 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
- 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
- Baseline prolongation of QT/QTc interval (QTc interval \> 470 msec in women and \>450 msec in men)
- 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
- Women who are pregnant or breastfeeding
- 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
- Prior history of clinically significant gastrointestinal bleeding, intestinal obstruction or gastrointestinal perforation within 6 months of study enrollment
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novita Pharmaceuticals, Inc.lead
- Translational Drug Developmentcollaborator
Study Sites (3)
HonorHealth Research Institute
Scottsdale, Arizona, 85258, United States
City of Hope National Medical Center
Duarte, California, 91010, United States
Memorial Sloan Kettering Hospital
New York, New York, 10065, United States
Related Publications (1)
Sever S. Role of actin cytoskeleton in podocytes. Pediatr Nephrol. 2021 Sep;36(9):2607-2614. doi: 10.1007/s00467-020-04812-z. Epub 2020 Nov 13.
PMID: 33188449DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jillian Zhang, Ph.D.
Novita Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2017
First Posted
June 27, 2017
Study Start
December 21, 2017
Primary Completion
May 7, 2020
Study Completion
May 7, 2020
Last Updated
July 20, 2025
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share