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Trial record 1 of 1 for:    IT-141
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Safety and Pharmacokinetic Study of IT-141 in Monotherapy in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT03096340
Recruitment Status : Unknown
Verified February 2018 by Intezyne Technologies, Inc..
Recruitment status was:  Recruiting
First Posted : March 30, 2017
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Intezyne Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE March 15, 2017
First Posted Date  ICMJE March 30, 2017
Last Update Posted Date February 12, 2018
Actual Study Start Date  ICMJE March 23, 2017
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
Maximum tolerated dose of IT-141 administered once every 2 weeks in patients with refractory solid tumors [ Time Frame: 18 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2017)
  • Adverse event profiles according to the Common Toxicity Criteria for Adverse Events (CTCAE, ver. 4.03) [ Time Frame: 18 months ]
  • Objective response rate based on RECIST [ Time Frame: 18 months ]
  • Area under the plasma concentration versus time curve (AUC) of SN-38 and SN-38G [ Time Frame: 18 months ]
  • Maximum plasma concentration (Cmax) of SN-38 and SN-38G [ Time Frame: 18 months ]
  • Time to Cmax (Tmax) of SN-38 and SN-38G [ Time Frame: 18 months ]
  • Elimination rate constant of SN-38 and SN-38G [ Time Frame: 18 months ]
  • Terminal half-life (t1/2) of SN-38 and SN-38G [ Time Frame: 18 months ]
  • Total plasma clearance (CL) of SN-38 and SN-38G [ Time Frame: 18 months ]
  • Volume of distribution (Vz) of SN-38 and SN-38G [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 24, 2017)
  • Overall Survival [ Time Frame: 18 months ]
  • Progression-free Survival [ Time Frame: 18 months ]
  • Time to progression [ Time Frame: 18 months ]
  • Disease Control Rate [ Time Frame: 2 years ]
  • MRI imaging for biodistribution of IT-141 [ Time Frame: 18 months ]
  • Presence of cfDNA [ Time Frame: 2 years ]
  • Presence of exosomes [ Time Frame: 2 years ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Safety and Pharmacokinetic Study of IT-141 in Monotherapy in Patients With Advanced Cancer
Official Title  ICMJE A Phase 1 With Expansion Cohort, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Intravenously Infused IT-141 in Subjects With Recurrent or Refractory Solid Tumors
Brief Summary IT141 is a novel nanoparticle formulation of SN-38, the active metabolite of irinotecan, and is intended to deliver more drug to the tumor with reduced toxicity on normal tissues. The study is designed to determine the maximum tolerated dose (MTD) of IT-141, and to investigate pharmacokinetic (PK) parameters and possible pharmacodynamics (PD) relationships. Patients will also be monitored for any response to therapy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Neoplasms
  • Tumors
  • Refractory Solid Tumors
  • Recurrent Solid Tumors
Intervention  ICMJE Drug: IT-141
Escalating doses administered in mg/m2, IV (in the vein) on days 1 and 15 of each 28 day cycle until progression or unacceptable toxicity develops.
Other Name: IT-141, 7-ethyl-10-hydroxycamptothecin
Study Arms  ICMJE Experimental: IT-141
Intervention: Drug: IT-141
Publications * Bakewell SJ, Carie A, Costich TL, Sethuraman J, Semple JE, Sullivan B, Martinez GV, Dominguez-Viqueira W, Sill KN. Imaging the delivery of drug-loaded, iron-stabilized micelles. Nanomedicine. 2017 May;13(4):1353-1362. doi: 10.1016/j.nano.2017.01.009. Epub 2017 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 24, 2017)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be 18 years of age or older.
  • Must be males or non-pregnant females who agree to comply with applicable contraceptive requirements of the protocol.
  • Must have a histologically or cytologically confirmed, incurable malignancy, for which further standard treatment is not currently available.
  • Must have measurable or evaluable disease during the dose escalation phase (measurable disease is preferred for the expanded cohort after MTD is reached).
  • Must have an anticipated survival of at least 12 weeks.
  • Must be fully informed regarding their illness and the investigational nature of the study protocol, and must sign an Institutional Review Board (IRB) approved Informed Consent Form (ICF).
  • Must be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1.
  • Must have adequate organ function, as defined by the following:
  • Hematologic: ANC 1.5 x 109/L, Hgb ≥ 9.0 g/dL and platelet count 100 x 109/L (platelet count > 75 x 109/L if documented evidence of bone marrow involvement).
  • Hepatic: Total bilirubin 1.5 x ULN; transaminases ≤ 2.5 x ULN (may be up to 5 x ULN if clearly due to liver metastases); prothrombin time (PT) and partial thromboplastin time (PTT) < 2 x (ULN).
  • Renal: Serum creatinine 1.5 x ULN or creatinine clearance 60 mL/min.
  • Must be on stable doses of any drugs affecting hepatic drug metabolism or renal drug excretion (e.g. non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates, diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be initiated less than 30 days prior to Baseline/C1D1 or at any time during study participation. Whenever possible, narcotic analgesic doses should be stable within 30 days prior to study entry and during the first cycle of therapy.
  • Must be recovered from any reversible side effects of prior therapy (e.g. no major surgery, no antineoplastic or experimental therapy, or no significant radiation therapy to hematopoietic sites within 4 weeks of Baseline/C1D1, and no nitrosoureas or nitrogen mustards within 6 weeks of Baseline/C1D1)
  • Must understand and be able, willing, and likely to fully comply with study procedures and restrictions.

Exclusion Criteria:

  • Current or recurrent disease that could affect the action or disposition of IT-141, or clinical or laboratory assessments.
  • Subjects with UGT1A1*28 polymorphisms.
  • Current or relevant previous history of serious, severe or unstable (acute or progressive) physical or psychiatric illness, including any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures.
  • Primary brain tumors or known brain metastasis unless clinically stable and on stable or reducing doses of steroids.
  • Frequent vomiting.
  • Recent history of unintentional weight loss > 10% of current body weight in the past 3 months.
  • Ongoing radiation therapy, chemotherapy, or hormonal therapy. Point radiation to a site of bone pain will be allowed.
  • Current (within 1 week of Screening) or regular use of any medication (including over-the-counter (OTC), herbal or homeopathic preparations) that could improve or worsen the cancer being studied, or could affect the action or disposition of IT-141, or its clinical or laboratory assessment; e.g. Coumadin therapy, due to high competitive protein binding. Subjects taking ANY supplemental IRON, i.e., therapeutic or as part of a multivitamin regimen, are excluded from this study, whether prescribed or self-medicated.
  • Concomitant use of a UGT1A1 inhibitor, such as idinavir, atazanavir and sorafenib, throughout the study period.
  • Known or suspected intolerance or hypersensitivity to IT-141 or any of the stated ingredients.
  • History of alcohol or other substance abuse within the last year.
  • History of use of another IP within the last 4 weeks prior to enrollment.
  • Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening.
  • Previous enrollment in this study, followed by withdrawal for any reason.
  • Known HIV-positive subjects on combination anti-retroviral therapy due to the potential for PK interactions with the study agent.
  • Evidence of ischemia or myocardial infarction within the past 6 months, or any significant abnormality on ECG.
  • A QTc interval outside of normal. (Normal: < 450 msec for males and < 460 msec for females)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03096340
Other Study ID Numbers  ICMJE IT141-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Intezyne Technologies, Inc.
Study Sponsor  ICMJE Intezyne Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Minal Barve, MD Mary Crowley Cancer Research Centers - Medical City
Principal Investigator: Kit Wong, MD Seattle Cancer Care Alliance
PRS Account Intezyne Technologies, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP