Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatmen… (NCT03199586) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies
United States23 participantsStarted 2017-12-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
Exclusion criteria
✕. 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