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Solid TumorPhase 1ONTRKNCT03182257

Study of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

A Phase 1 study testing ONO-7579 in people with Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 5 sites in 2 countries.

Terminated

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

Official record
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Trial summary

This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid tumors harboring NTRK gene fusions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
ONO-7579
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
5 sitesin 2 countries
Study dates
12 Jul 2017to 30 Jan 2018
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

  • Male or female aged at least 18 years or older, at the time of signing the informed consent form.
  • The patient (or their legal representative) has provided written informed consent, which signifies an agreement to enter the study and comply with the restrictions and requirements listed in the informed consent form.
  • ECOG performance status ≤ 2
  • Life expectancy of at least 3 months
  • Patients must have measurable disease, according to RECIST 1.1 (defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm (≥2 cm) with conventional techniques or as ≥10 mm (≥1 cm) with spiral CT scan), or RANO criteria for Glioma.
  • Patients must have received at least one prior line of therapy appropriate for their tumor type and stage of disease. For glioma, patient must have received at least one prior treatment with radiotherapy and temozolomide. Prior treatment of any Trk inhibitor(s) is not an exclusion.
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  • Adequate hematologic, hepatic and renal function as defined by the following criteria:
  • Absolute Neutrophil count ≥ 1.5x109
  • Platelet count ≥ 75,000 / mm3
  • Hemoglobin level ≥ 9.0 g/dL
  • Total Bilirubin level ≤ 1.5 X ULN
  • AST and ALT ≤ 3 X ULN
  • Creatinine clearance* ≥50 mL/min *estimated CLcr by the Cockcroft-Gault equation
  • Women of:
  • Childbearing potential must have a negative serum pregnancy test documented within 14 days prior to enrollment, and must agree to use two adequate methods of contraception from Day 1 of the study until 3 months after the end of treatment. Acceptable forms of effective contraception include;
  • Established use of oral, injected or implanted hormonal methods of contraception.
  • Placement of an intrauterine device or intrauterine system.
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
  • Male sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
  • Non-childbearing potential, defined as females with a documented history of a clinically recognized procedure (e.g. hysterectomy, tubal ligation, bilateral salpingo-/oophorectomy) ; or postmenopausal defined as 12 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) >40 MlU/mL). Females on hormone replacement therapy (HRT) will be required to use one of the contraception methods in Inclusion criteria 8a or must discontinue HRT to allow confirmation of post-menopausal status prior to being enrolled in the study. Following confirmation of their post-menopausal status, they can resume HRT during the study and will not be required to use contraception.
  • A male patient is eligible to participate if he is not trying to father a child and is willing to use one of the relevant contraception methods as in inclusion criterion 8a from Day 1 of the study until 3 months after the end of treatment.
  • Able to swallow tablets
  • Patients must be recovered to Grade 1 from the effects (excluding alopecia) of any prior therapy for their malignancies.
  • Additional Criterion for Part A only
  • Patients with histologically/cytologically confirmed advanced solid tumors, and documented tumor progression for whom no further standard anticancer treatment is available.
  • Patients must be able to comply with the protocol requirements regarding fasting, as determined by the investigator (excluding patients in food assessment cohort(s)).
  • Additional Criteria for Part B only
  • Patients with histologically/cytologically confirmed advanced solid tumors and documented tumor progression for whom no further standard anticancer treatment exists or where, in the opinion of the investigator, the existing standard anticancer treatment options available are not expected to provide a reasonable benefit to the patient.
  • Patients must have NTRK1, NTRK2 or NTRK3 gene fusion confirmed locally prior to first dose.

Who cannot join

  • Radiotherapy within two weeks prior to study entry
  • Major surgery (excluding placement of vascular access) within 4 weeks before the first dose of study treatment
  • Spinal cord compression or brain metastases unless treated and radiologically stable for >6 weeks post treatment and not requiring steroids for at least 4 weeks prior to start of study treatment
  • As judged by the Investigator, any evidence of severe or uncontrolled psychiatric disease or systemic diseases, including history of suicide attempt or current suicidal ideation or behavior, active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). Screening for chronic conditions is not required.
  • Concurrent treatment with another investigational agent or participated in another investigational trial within 30 days of study entry
  • Diagnosed or treated for a malignancy other than the tumor under investigation in the study within 5 years, or who were previously diagnosed with a malignancy other than that required for the study and have any radiographic or biochemical marker evidence of that malignancy. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
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  • Clinically significant cardiovascular disease, including:
  • History of myocardial infarction, acute coronary syndromes (including unstable angina), or coronary angioplasty/stenting/bypass grafting within the past 6 months.
  • History of Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
  • Severe cardiac arrhythmia requiring medication or other severe conduction abnormalities (e.g. clinically significant QT prolongation or Torsade de pointes)
  • Uncontrolled hypertension
  • Clinically significant valvular disease, cardiomegaly, ventricular hypertrophy, or cardiomyopathy
  • QT prolongation defined as a QTcF interval >470 msec or other significant ECG abnormalities including 2nd degree (type II) or 3rd degree AV block or bradycardia (ventricular rate <50 beats/min) on 12-lead ECG at screening
  • Serious concurrent medical conditions, including serious active infection, in the opinion of the investigator
  • Female patients who are pregnant or breast feeding

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

United States4 sites

  • Mary Crowley Cancer Research Center

    Dallas, Texas, 75230

  • Greenville Hospital System University Medical Center

    Greenville, South Carolina, 29605

  • Montefiore Medical Center

    Lake Success, New York, 11041

  • Mount Sinai

    New York, New York, 10029

Other trials in United States

United Kingdom1 site

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

Other trials in United Kingdom

About this study

Official title: An Open-label, Multi-center, Dose-escalation and Expansion Study to Evaluate the Safety and Efficacy of ONO-7579 in Patients With Advanced Solid Tumors/ NTRK Gene Fusion Positive Advanced Solid Tumors

This study will determine the safety and maximum tolerated dose of ONO-7579 in patients with advanced solid tumors, and evaluate efficacy of ONO-7579 in patients with advanced solid tumors harboring NTRK gene fusions.

Read the detailed description

The trial was designed to be a Phase 1/2 trial, but was terminated without progressing to Phase 2.

Conditions
Solid Tumor
Being tested
ONO-7579
Keywords
TRK, TRKA, TRKB, TRKC, NTRK1, NTRK2, NTRK3, NTRK fusion positive, NTRK1 fusion, NTRK2 fusion, NTRK3 fusion, NTRK1 gene rearrangement, NTRK2 gene rearrangement, NTRK3 gene fusion, ETV6-NTRK3, fusion, tumors, solid tumors, CNS tumors, central nervous system tumors
Medical subject headings
Neoplasms, Central Nervous System Neoplasms

What participants receive

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

  • ONO-7579Drug

    ONO-7579 Tablets

Study groups in NCT03182257
Study groupRoleWhat they receive
ONO-7579 Part AExperimentalSingle Ascending doses of ONO-7579
Receives: Drug: ONO-7579
ONO-7579 Part BExperimentalExpansion phase of ONO-7579
Receives: Drug: ONO-7579

What is being measured

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

  1. Part A: Incidence, nature and severity of Adverse Events

    To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD

    Measured: up to 28 days

  2. Part A: Clinically significant changes in physical examinations

    To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD

    Measured: up to 28 days

  3. Part A: Clinically significant changes in neurological examinations

    To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD

    Measured: up to 28 days

  4. Part A: Clinically significant changes in vital signs and electrocardiogram - including the evaluation of the QT interval

    To investigate the safety and tolerability of ONO-7579 to determine MTD/RCD

    Measured: up to 28 days

  5. Part B: Overall Response Rate (ORR)

    Assessed by Independent Central Review using RECIST 1.1 or RANO criteria

    Measured: up to 24 months

Secondary outcomes (16)

  1. Part A and B Pharmacokinetics (Cmax)

    Assessment of the maximum plasma concentration of ONO-7579

    Measured: Day 1, 2, 7, 14 and 28

  2. Part A and B Pharmacokinetics (Tmax)

    Assessment of the time to reach maximum observed plasma concentration of ONO-7579

    Measured: Day 1, 2, 7, 14 and 28

  3. Part A and B Pharmacokinetics (AUC)

    Assessment of the plasma area under the curve from time zero to 24 hours after dosing

    Measured: Day 1, 2, 7, 14 and 28

  4. Part A and B Pharmacokinetics (T1/2)

    Assessment of the plasma decay half life of ONO-7579

    Measured: Day 1, 2, 7, 14 and 28

  5. Part A and B Pharmacokinetics (Ctrough)

    Assessment of the trough concentration of ONO-7579 in plasma

    Measured: Day 1, 2, 7, 14 and 28

  6. Part A Overall Response Rate (ORR)

    Assessed by investigator using RECIST 1.1 or RANO criteria

    Measured: up to 28 days

  7. Part A Duration of Response (DoR)

    Assessed by investigator using RECIST 1.1 or RANO criteria

    Measured: up to 28 days

  8. Part A Progression Free Survival (PFS)

    Assessed by investigator using RECIST 1.1 or RANO criteria

    Measured: up to 28 days

  9. Part B Progression Free Survival (PFS)

    Assessed by Independent Central Review using RECIST 1.1 or RANO criteria

    Measured: up to 24 months

  10. Part B Overall Survival (OS)

    Assessed by Independent Central Review using RECIST 1.1 or RANO criteria

    Measured: up to 24 months

  11. Part B Time to Response (TTR)

    Assessed by Independent Central Review using RECIST 1.1 or RANO criteria

    Measured: up to 24 months

  12. Part B Time to Progression (TTP)

    Assessed by Independent Central Review using RECIST 1.1 or RANO criteria

    Measured: up to 24 months

  13. Part B Incidence, nature and severity of Adverse Events

    To determine the safety and tolerability of ONO-7579

    Measured: up to 24 months

  14. Part B: Clinically significant changes in physical examinations

    To determine the safety and tolerability of ONO-7579

    Measured: up to 24 months

  15. Part B: Clinically significant changes in neurological examinations

    To determine the safety and tolerability of ONO-7579

    Measured: up to 24 months

  16. Part B: Clinically significant changes in vital signs and electrocardiogram - including the evaluation of the QT interval

    To determine the safety and tolerability of ONO-7579

    Measured: up to 24 months

Timeline

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

  1. First posted9 Jun 2017
  2. Study start12 Jul 2017
  3. Primary completion30 Jan 2018
  4. Study completion30 Jan 2018

Why it stopped: The study was stopped for commercial reasons. No safety issues were reported.

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03182257
Sponsor's protocol ID
ONO-7579-01
Acronym
ONTRK
Status last verified
Sep 2019
First submitted
19 May 2017
Last updated
13 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ONO-7579 in people with Solid Tumor, run by Ono Pharmaceutical Co., Ltd. at 5 sites in 2 countries.

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 29 inclusion and 15 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 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, United Kingdom. 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: The study was stopped for commercial reasons. No safety issues were reported.). 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?

Part A: Incidence, nature and severity of Adverse Events (time frame: up to 28 days). The study lists 5 primary outcomes in all. 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 NCT03182257.

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 13 Sep 2019.

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