NP-G2-044 Monotherapy for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Cleveland, OH
Cancer+1 More
NP-G2-044 Monotherapy - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug called NP-G2-044 can be used to treat cancer.

See full description

Eligible Conditions

  • Cancer
  • Advanced or Metastatic Solid Tumor Malignancies

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether NP-G2-044 Monotherapy will improve 6 primary outcomes and 7 secondary outcomes in patients with Cancer. Measurement will happen over the course of Time of first dose of any study drug(s) until 30 days after the last dose of study drug(s).

24 months
Identify and characterize preliminary anti-tumor activity of NP-G2-044 in combination with anti-PD-(L)1 therapy
NP-G2-044 anti-tumor preliminary efficacy signals when administered as continuously dosed monotherapy assessed by RECIST 1.1
NP-G2-044 anti-tumor preliminary efficacy signals when administered in combination with anti-PD-(L)1 therapy assessed by RECIST 1.1
6 months
Identification of the NP-G2-044 Monotherapy Recommended Phase 2 Dose (RP2D)
Pharmacokinetics (PK) of NP-G2-044 monotherapy: AUC
Pharmacokinetics (PK) of NP-G2-044 monotherapy: Cmax
Pharmacokinetics (PK) of NP-G2-044 monotherapy: Tmax
9 months
Identification of the RP2D for patients receiving NP-G2-044 in combination with anti-PD-(L)1 therapy
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-(L)1 Combination therapy: AUC
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-(L)1 Combination therapy: Cmax
Pharmacokinetics (PK) of NP-G2-044 and anti-PD-(L)1 Combination therapy: Tmax
Day 30
Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 and anti-PD-(L)1 combination therapy
Number of incidences of Treatment Emergent Adverse Events with NP-G2-044 monotherapy

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

NP-G2-044 Combination Therapy With Anti-PD-(L)1 Therapy
1 of 2
NP-G2-044 Monotherapy
1 of 2
Experimental Treatment

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. NP-G2-044 Monotherapy is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

NP-G2-044 Combination Therapy With Anti-PD-(L)1 TherapyNP-G2-044 capsule PO QD for each 28-day cycle, Anti-PD-(L)1 Therapy per standard of care, at a dose and frequency in accordance with the package insert
NP-G2-044 Monotherapy
Drug
NP-G2-044 capsule PO QD for each 28-day cycle

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

University Hospitals Cleveland Medical Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patient has ANC >1500 cells/μL; Hemoglobin >9.0 g/dL; Platelet count >100,000 cells/μL; Total bilirubin ≤1.5 mg/dL; Albumin ≥3.0 g/dL; Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and gamma-glutamyl transferase ≤2.5 × upper limit of normal (ULN); Serum creatinine ≤1.5 mg/dL and creatinine clearance ≥60 mL/min/1.73 m2. show original
The patient is able to understand what the consent form says and is willing and able to comply with the study requirements. show original
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 means that you are able to carry out all normal activities without any restrictions. show original
Female patients of childbearing potential must have a negative serum or urine pregnancy test at Screening and within 72 hours before the first dose of NP-G2-044 show original
A person who is male or female and at least 18 years old. show original
The patient is expected to live for six more months. show original
This product is easy to swallow capsules. show original
female patients must be surgically sterile or using a highly effective double-barrier contraception method (eg, female condom with diaphragm or female condom with cervical cap) upon study entry, while on NP-G2-044, and for a period of at least 1 month following the last dose of NP-G2-044 show original
Have a solid tumor malignancy that is at an advanced stage or has spread to other parts of the body and is not responding to treatment or is not eligible for treatment with the standard methods. show original
The patient has a measurable disease that meets the requirements of RECIST 1.1. show original

Patient Q&A Section

What are the signs of cancer?

"Abnormal lung function has been reported to be a risk factor for cancer. However, the presence of lung cancer does not affect lung function parameters in asymptomatic smokers with airflow obstruction." - Anonymous Online Contributor

Unverified Answer

What is cancer?

"A cancer is any type of tumor that forms in a part of the body and grows in a way that makes it difficult the body to function, stops the body from healing naturally and eventually destroys it. For those reasons, cancer causes people great suffering. In the 21st century, cancers kill about 4 million adults per year and 5.3 million children under 19 annually." - Anonymous Online Contributor

Unverified Answer

How many people get cancer a year in the United States?

"In the US it is estimated that 1.5 million people are diagnosed with cancer each year. Of these, nearly 40,000 die. While cancer can be a serious, chronic and life threatening disease, it is also an illness that can be managed." - Anonymous Online Contributor

Unverified Answer

Can cancer be cured?

"Findings from a recent study shows that an impressive proportion of patients who were treated with radical surgery and/or radiotherapy will have a long-term survival of at least four years after the treatment of recurrent disease, although very few patients will be cured of cancer, and many more patients die of other causes. The use of radiotherapy has no curative effect on the most common forms of cancer. Chemotherapy with curative intent has a poor acceptance by patients, with very few patients having a cure of their disease. Findings from a recent study suggests chemotherapy as a treatment of second or later stages of disease, and use of multimodality therapy, using the current most aggressive radiation therapy with a combination of chemotherapy, surgery and radiotherapy when clinically justified." - Anonymous Online Contributor

Unverified Answer

What are common treatments for cancer?

"A relatively high percentage of patients who develop cancer receive no treatment at the time of diagnosis. Almost all of the treatments that patients receive are for the prevention and/or treatment of the disease. Thus, the majority of the cancer patients receive treatment at some point during their lifetime regardless of their disease stage. However, less than half of those patients who receive treatment have persistent disease. These and other information should facilitate a discussion with patients about the risks and benefits of the various treatments and should aid physicians and patients in making patient-centered decisions about treatment protocols. This concept is called ethical informed consent." - Anonymous Online Contributor

Unverified Answer

What causes cancer?

"The study shows that the link between mental health and cancer is not direct, as in common belief. One cause of mental health problems that might lead to cancer might be social adversity or other environmental factors. It is vital to develop more detailed research on these links that can make it easier to target effective interventions to those in highest risk of developing cancer." - Anonymous Online Contributor

Unverified Answer

Does np-g2-044 monotherapy improve quality of life for those with cancer?

"PNP-g2-044 is safe and effective, with a high degree of patient satisfaction (89%). The high rates of QOL improvements support further exploration of the therapeutic potential of pNP g2-044 for cancer treatment." - Anonymous Online Contributor

Unverified Answer

How serious can cancer be?

"If American physicians and consumers are truly focused on the prevention, detection, and treatment of cancer, and really caring about these matters and the people affected by cancer then then we can get closer to curtailing cancer and advancing the ultimate cause of world- class medical advancement - the cure for all cancers\n" - Anonymous Online Contributor

Unverified Answer

What is the latest research for cancer?

"There seems to be a gap in the international published scientific literature on cancer. To fill this gap, it may be an appropriate time for a consortium of scientists to begin systematic review of the international literature on cancer." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for cancer?

"Findings from a recent study of two trials suggest the value of referral from a cancer registrar to patients as a means of attracting potentially eligible patients for clinical trials." - Anonymous Online Contributor

Unverified Answer

Does cancer run in families?

"The family prevalence of cancer increases with higher parity of mothers and lower education in the sons. Familial clustering in cancer increases with older age of cancer in relatives. It is advisable to obtain family history of cancer from younger family members in any form." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating cancer?

"There has been a continuous process of discovery of new treatments for cancer. In the past 20 years, there have been several therapeutic approaches that have shown to offer an alternative to chemotherapy; unfortunately, none have been proven to work in clinic. Since many new molecules for therapy are coming out, it is not sure which one to use. On the other hand, it is also necessary to identify what are the mechanisms of resistance against a specific drug. But at the moment this is one of the big problems. It has been confirmed for many years that chemotherapy induces resistance in some patients to the treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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