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Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03168035
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
NanoCarrier Co., Ltd.

Brief Summary:
The goal of this clinical research study is to find the highest tolerated dose of NC-4016 that can be given to patients with advanced solid tumors or lymphoma. The safety of the drug will also be studied.

Condition or disease Intervention/treatment Phase
Advanced Cancer Lymphoma Drug: NC-4016 Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation and Pharmacokinetic Study of NC-4016 in Patients With Advanced Solid Tumors or Lymphoma
Actual Study Start Date : November 2013
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: NC-4016

Dose Escalation Group: NC-4016 will be administered as 2-hour intravenous infusion once every 3 weeks. Initial dose level 15 mg/m2. The dose level of NC-4016 in subsequent cohorts determined by the toxicity profile of the previous cohort, and dose level increased to 25, 30, 40, 60, and 80 mg/m2 or higher at each subsequent cycle until the highest dose level is reached or DLT prohibits further dose-level escalation. Dose level 1 will be the starting dose level (DL). If 2 out of the first 3 patients enrolled at DL1 experience a DLT during Cycle 1 or Cycle 2,then the next cohort of patients will be enrolled at DL0 (10 mg/m2).

Dose Expansion Group: Maximum tolerated dose from Dose Escalation Group

Drug: NC-4016

Dose Escalation Group Starting Dose: 15 mg/m2 by vein on Day 1 of a 21 Day cycle.

Dose Expansion Group Starting Dose: Maximum tolerated dose from Dose Escalation Group.





Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of NC-4016 [ Time Frame: 21 days ]
    MTD defined as the highest dose level at which no more than 1 of 6 dose limiting toxicity (DLT) evaluable patients experience a DLT during Cycle 1 of dosing. DLT determined by NCI CTCAE v4.03, 14 June 2010.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: During the First 4 Cycles of Treatment (each cycle is 21 days) ]
    calculated for all patients using noncompartmental analysis

  2. Tmax [ Time Frame: During the First 4 Cycles of Treatment (each cycle is 21 days) ]
    calculated for all patients using noncompartmental analysis

  3. AUC [ Time Frame: During the First 4 Cycles of Treatment (each cycle is 21 days) ]
    calculated for all patients using noncompartmental analysis

  4. T1/2 [ Time Frame: During the First 4 Cycles of Treatment (each cycle is 21 days) ]
    calculated for all patients using noncompartmental analysis

  5. CL [ Time Frame: During the First 4 Cycles of Treatment (each cycle is 21 days) ]
    calculated for all patients using noncompartmental analysis

  6. Vss [ Time Frame: During the First 4 Cycles of Treatment (each cycle is 21 days) ]
    calculated for all patients using noncompartmental analysis

  7. Vz [ Time Frame: During the First 4 Cycles of Treatment (each cycle is 21 days) ]
    calculated for all patients using noncompartmental analysis

  8. Excretion Profile of Total and Free (Ultrafiltrate) Platinum (Pt) [ Time Frame: Cycle 1 and Cycle 3 (each cycle is 21 days) ]


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:

  1. Have signed written informed consent prior to the initiation of any study-specific procedures
  2. Be a male or female 18 years or older
  3. Have a histologically or cytologically confirmed diagnosis of advanced solid tumor or lymphoma, or primitive hepatocarcinoma with radiological diagnosis
  4. Have advanced or metastatic disease refractory to standard curative or palliative therapy or contraindication to standard therapy
  5. Have an ECOG performance status of 0-2
  6. Have adequate bone marrow reserve: a. Absolute neutrophil count at least 1.5 x 10^9/L, b. Platelet count at least 100 x 10^9/L, and c. Hemoglobin at least 10 g/L (transfusion is allowed to achieve hemoglobin of 10 g/L)
  7. Have adequate liver function: a. Total serum bilirubin no more than 1.5 x upper limit of normal (ULN), and b. Alanine aminotransferase and aspartate aminotransferase<= 2.5 x ULN or <= 5.0 x ULN in case of documented hepatic metastasis
  8. Have adequate renal function: glomerular filtration rate >=50 mL/min (calculated according to the formula of Cockcroft and Gault)
  9. Be reasonably recovered from preceding major surgery as judged by the investigator or no major surgery within 4 weeks prior to the start of Day 1 treatment
  10. Have a negative pregnancy test for females at screening, preferably done within 1 week before Day 1 of treatment (not applicable to patients with bilateral oophorectomy and/or hysterectomy)
  11. Be willing to abstain from heterosexual activity or practice physical barrier contraception from study entry to 6 months after the last day of treatment

Exclusion Criteria:

  1. Have peripheral neuropathy of Grade 3 or Grade 4 at screening, according to National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)v4.03, 14 June 2010 scale; or TNSc score greater than 4
  2. Have an interval from previous neurotoxic platinums of less than 6 months and/or from previous other neurotoxic drugs less than 3 months (eg, taxanes) unless reasonably recovered from all grades of neurotoxicity as judged by the investigator
  3. Have a history of thrombocytopenia with complications including hemorrhage or bleeding >= Grade 2 using NCI CTCAE v4.03, 14 June 2010 that required medical intervention or any hemolytic condition or coagulation disorders that would make participation unsafe in the opinion of the investigator
  4. Have unresolved toxicity from previous treatment or previous investigational agents; excluding alopecia. Clinical judgment by the investigator is allowed to determine if grade 1 fatigue at screening is residual toxicity from prior treatment or is a symptom of the patient's general condition or disease. The investigator and medical monitor will discuss the eligibility of patients with baseline toxicity
  5. Have known hypersensitivity to Pt compounds
  6. Have received investigational agents or systemic anticancer agents (other than neurotoxic compounds) within 14 days of Day 1 of treatment, or 28 days for those agents with unknown elimination half-lives, or known elimination half-lives greater than 50 hours; or 6 weeks for mitomycin C or for nitrosourea agents
  7. Is pregnant or breast-feeding
  8. Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions which, in the opinion of the investigator, make it undesirable for the patient to participate in the study, or which could jeopardize compliance with the protocol
  9. Have experienced any of the following within the 6-month period prior to screening: angina pectoris, coronary artery disease or cerebrovascular accident, transient ischemic attack, cardiac failure with known ejection fraction less than 40%, or cardiac arrhythmia requiring medical therapy
  10. Have known hepatitis B or C, or human immunodeficiency virus infection
  11. Is unwilling or unable to comply with study procedures, or is planning to take a vacation for 7 or more consecutive days during the treatment phase of the study

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): NCT03168035


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
NanoCarrier Co., Ltd.
M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: NanoCarrier Co., Ltd.
ClinicalTrials.gov Identifier: NCT03168035     History of Changes
Obsolete Identifiers: NCT01999491
Other Study ID Numbers: NC-4016-001
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
NC-4016
Antineoplastic Agents