Phase 1 Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Solid Tumors (Including Lymphoma)

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: - Disease Related - Patients must have documented history of histologically confirmed solid tumors (as defined by ASCO/CAP guidelines) originating in breast, pancreas, prostate, lung, colon, esophagus, liver, or ovary, and lymphomas, which are locally advanced or metastatic and who are refractory or intolerant beyond primary treatment for their malignancy, or for lymphoma patients who are not eligible for or who have refused autologous or allogenic hematopoietic stem cell transplant - Measurable or evaluable disease documented within one month of the planned protocol treatment (Treatment Period Cycle 1, Day 1)first dose of study drug (PK Period Day 1) - ECOG performance score of 0 and 1 - Able to swallow capsules/tablets Demographic • Male and females who are 18 years or older Laboratory Values - Hemoglobin ≥ 9.0 g/dL - Absolute neutrophil count ≥ 1500/uL - Platelet count ≥ 100,000/uL - Serum creatinine ≤ 1.5 mg/dL or a 24-hour calculated estimated creatinine clearance of ≥ 60 mL/min - Serum bilirubin ≤ 1.5 mg/dL - Serum albumin ≥ 3g/dL - AST (SGOT), ALP and ALT (SGPT) ≤ 2.5 times upper limit of normal (OR ≤ 5 times ULN in the presence of known liver metastases) - Prothrombin time (PT)/International Normalized Ratio (INR) and partial thromboplastin time (PPT) ≤ 1.5 times the upper limit of normal - Serum sodium, potassium, magnesium, calcium and phosphorous levels within institutional normal limits; supplements required to maintain normal electrolyte levels will be permitted Ethical • Before any study-specific procedure, the appropriate written informed consent must be obtained Exclusion Criteria: Disease Related - Clinical or radiographical evidence of active brain metastasis - Patients who have not recovered to ≤ grade 1 toxicities except grade 2 alopecia or neuropathy associated with previous chemotherapy, radiotherapy, biologic, hormone or prior investigational therapies. Medications: - Chemotherapy or other cancer, radiation or surgical treatments within 2 weeks or five half-lives (whichever is shorter) of the first dose of study drug (PK Period Day 1) planned first protocol treatment (i.e., cycle 1 day 1) or not yet recovered from respective treatments - Patients who have had allogenic hematopoietic stem cell transplant or allogenic bone marrow transplant - Patients who have had prior solid organ transplant - Patients who are on immune suppression drugs or anti-transplant rejection drugs General: - History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that in the opinion of the investigator, may increase the risks associated with study participation or treatments that may interfere with the conduct of the study or the interpretation of study results - Prior history of clinically significant gastrointestinal bleeding, intestinal obstruction or gastrointestinal perforation within 6 months before planned initiation of study treatment - Uncontrolled diabetes - History of long QT syndrome or clinically significant cardiac arrhythmia, other than stable atrial fibrillation - Mean QTcF > 450 msec in men and mean QTcF > 470 msec in women at screening - Myocardial infarction within the previous 6 months before planned initiation of study treatment - Active infection requiring intravenous antibiotics within 2 weeks of the first dose of study drug (PK Period Day 1) before planned initiation of study treatment - Prior history or current positive tests for hepatitis B, hepatitis C or human immunodeficiency virus - Currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study before planned date of first dose, or the patient is currently receiving other investigational agent(s) - Pregnant, planning a pregnancy or breast feeding during the study - Male or female not willing to use adequate contraceptive precautions during the study period - Unwilling or unable to comply with study requirements or not available for follow-up assessments - Any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures.

Locations & Contacts

California

Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Contact: Vincent Chung
Phone: 626-218-1133

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Novita Pharmaceuticals, Inc.

Trial IDs

Primary ID NP-G2-044-P1-01
Secondary IDs NCI-2017-02158
Clinicaltrials.gov ID NCT03199586