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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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