TerminatedPhase 1

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

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

United States, United Kingdom1 participantsStarted 2017-07-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Incidence, nature and severity of Adverse Events

Timeframe: up to 28 days

Part A: Clinically significant changes in physical examinations

Timeframe: up to 28 days

Part A: Clinically significant changes in neurological examinations

Timeframe: up to 28 days

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

Timeframe: up to 28 days

Part B: Overall Response Rate (ORR)

Timeframe: up to 24 months

Trial details

NCT IDNCT03182257

SponsorOno Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-01-30

View on ClinicalTrials.gov More Solid Tumor trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

What they're measuring

Part A: Incidence, nature and severity of Adverse Events

Timeframe: up to 28 days

Part A: Clinically significant changes in physical examinations

Timeframe: up to 28 days

Part A: Clinically significant changes in neurological examinations

Timeframe: up to 28 days

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

Timeframe: up to 28 days

Part B: Overall Response Rate (ORR)

Timeframe: up to 24 months