Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Treatment-Refractory Solid Tumor Malignancies

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03199586
• Other study ID #: NP-G2-044-P1-01
• Status: Completed
• Phase: Phase 1
• Start date: December 21, 2017
• Est. completion date: May 7, 2020

Study information

• Verified date: December 2020
• Source: Novita Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 7, 2020
• Est. primary completion date: May 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced or Metastatic Treatment-refractory Solid Tumor Malignancies
• Breast Cancer
• Colon Cancer
• Esophageal Neoplasms
• Esophagus Cancer
• Liver Cancer
• Lung Cancer
• Neoplasms
• Ovarian Neoplasms
• Ovary Cancer
• Pancreas Cancer
• Pancreatic Neoplasms
• Prostate Cancer

Intervention

Drug:
• NP-G2-044
capsule

Locations

Country	Name	City	State
United States	City of Hope National Medical Center	Duarte	California
United States	Memorial Sloan Kettering Hospital	New York	New York
United States	HonorHealth Research Institute	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Novita Pharmaceuticals, Inc.	Translational Drug Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Establish the safe recommended phase 2 dose	Treatment related adverse events assessed by CTCAE V4.03	24 months
Secondary	Identify and characterize preliminary anti tumor activity	Anti tumor activity assessed using RECIST 1.1	24 months
Secondary	Characterize the pharmacokinetics of NP-G2-044	Drug exposure assessed by area under the curve (AUC)	24 months
Secondary	Tmax	Time to peak plasma concentration	24 months
Secondary	Cmax	Peak plasma concentration	24 months