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CancerPhase 1NCT03096340

Safety and Pharmacokinetic Study of IT-141 in Monotherapy in Patients With Advanced Cancer

A Phase 1 study testing IT-141 in people with Cancer and Neoplasms, run by Intezyne Technologies, Inc. at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer, Neoplasms, Tumors
What is being tested?
IT-141
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesUnited States
Study dates
23 Mar 2017to 26 Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
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  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Mary Crowley Cancer Research Centers - Medical City

    Dallas, Texas, 75230

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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

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.

Being tested
IT-141
Keywords
SN-38, irinotecan
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IT-141Drug

    Also called IT-141, 7-ethyl-10-hydroxycamptothecin

    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.

Study groups in NCT03096340
Study groupRoleWhat they receive
IT-141ExperimentalNot described
Receives: Drug: IT-141

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose of IT-141 administered once every 2 weeks in patients with refractory solid tumors

    Measured: 18 months

Secondary outcomes (9)

  1. Adverse event profiles according to the Common Toxicity Criteria for Adverse Events (CTCAE, ver. 4.03)

    Measured: 18 months

  2. Objective response rate based on RECIST

    Measured: 18 months

  3. Area under the plasma concentration versus time curve (AUC) of SN-38 and SN-38G

    Measured: 18 months

  4. Maximum plasma concentration (Cmax) of SN-38 and SN-38G

    Measured: 18 months

  5. Time to Cmax (Tmax) of SN-38 and SN-38G

    Measured: 18 months

  6. Elimination rate constant of SN-38 and SN-38G

    Measured: 18 months

  7. Terminal half-life (t1/2) of SN-38 and SN-38G

    Measured: 18 months

  8. Total plasma clearance (CL) of SN-38 and SN-38G

    Measured: 18 months

  9. Volume of distribution (Vz) of SN-38 and SN-38G

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2017
  2. Study start23 Mar 2017
  3. Primary completion22 Aug 2018
  4. Study completion26 Nov 2019

Why it stopped: Terminated by sponsor.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03096340
Sponsor's protocol ID
IT141-001
Status last verified
Jan 2020
First submitted
15 Mar 2017
Last updated
22 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 28115246

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IT-141 in people with Cancer and Neoplasms, run by Intezyne Technologies, Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated by sponsor.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose of IT-141 administered once every 2 weeks in patients with refractory solid tumors (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03096340, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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