Breast Cancer, Pancreas Cancer, Prostate Cancer, Lung Cancer, Colon Cancer, Esophagus Cancer, Liver Cancer, Ovary Cancer, Advanced or Metastatic Treatment-refractory Solid Tumor Malignancies
Conditions
Keywords
Advanced or metastatic treatment-refractory solid tumor malignancies
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.
Interventions
DRUGNP-G2-044
capsule
Sponsors
Translational Drug Development
Novita Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Establish the safe recommended phase 2 dose | 24 months | Treatment related adverse events assessed by CTCAE V4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify and characterize preliminary anti tumor activity | 24 months | Anti tumor activity assessed using RECIST 1.1 |
| Characterize the pharmacokinetics of NP-G2-044 | 24 months | Drug exposure assessed by area under the curve (AUC) |
| Tmax | 24 months | Time to peak plasma concentration |
| Cmax | 24 months | Peak plasma concentration |
Countries
United States
Outcome results
None listed