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

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ClinicalTrials.gov Identifier: NCT03199586
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : March 20, 2018
Sponsor:
Collaborator:
Translational Drug Development
Information provided by (Responsible Party):
Novita Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Pancreas Cancer Prostate Cancer Lung Cancer Colon Cancer Esophagus Cancer Liver Cancer Ovary Cancer Lymphoma Drug: NP-G2-044 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-Human, Dose Finding, Open Label Phase 1 Clinical Trial of Metastasis Inhibitor NP-G2-044 in Patients With Advanced or Metastatic Solid Tumors (Including Lymphoma)
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019


Arm Intervention/treatment
Experimental: NP-G2-044
capsule
Drug: NP-G2-044
capsule




Primary Outcome Measures :
  1. Number of participants with treatment related adverse events [ Time Frame: 24 months ]
    as assessed by CTCAE V4.03


Secondary Outcome Measures :
  1. Anti tumor activity [ Time Frame: 24 months. ]
    Resist 1.1



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199586


Contacts
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Contact: Rachel Condjella, PhD 602.358.8318 rcondjella@td2inc.com

Locations
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United States, Arizona
HonorHealth Research Institute Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Joyce Schaffer, MSN, RN, AOCNS    480-323-1791      
Principal Investigator: Frank Tsai, MD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Clinical Trials Hotline Study Number 17345    877-467-3411      
Contact    626-218-1133      
Principal Investigator: Vincent Chung, MD         
United States, New York
Memorial Sloan Kettering Hospital Recruiting
New York, New York, United States, 10065
Contact: Ann E Sisk    646-888-4226      
Principal Investigator: Komal Jhaveri, MD         
Sponsors and Collaborators
Novita Pharmaceuticals, Inc.
Translational Drug Development
Investigators
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Study Director: Jillian Zhang, Ph.D. Novita Pharmaceuticals

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Responsible Party: Novita Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03199586     History of Changes
Other Study ID Numbers: NP-G2-044-P1-01
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lymphoma
Liver Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Ovarian Neoplasms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Gonadal Disorders