CompletedPhase 1

A Study of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin) in Participants With Solid Tumors

Japan82 participantsStarted 2017-11-28

Plain-language summary

The primary objective of this study is to evaluate the tolerability and safety profile of farletuzumab ecteribulin in participants with solid tumors.

Who can participate

Age range

20 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

. Hemoglobin \>=9.0 grams per deciliter (g/dL).
. Neutrophil count \>=1.5 × 10\^3/microliters (μL).
. Platelet count \>=10 × 10\^4/μL.
. Total bilirubin \<=1.5 × upper limit of normal (ULN) in the facility.
. Alanine aminotransferase and aspartate aminotransferase \<=3.0 × ULN in the facility (in the case of liver metastases \<=5\*ULN).
. Serum creatinine \<=1.5 × ULN in the facility.
. Albumin \>=3 g/dL.
. At least 1 lesion of \>=1.0 centimeters (cm) in the longest diameter for a non-lymph node or \>=1.5 cm in the short-axis diameter for a lymph node that is measurable according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 using computerized tomography/magnetic resonance imaging.

Exclusion criteria

. Congestive heart failure greater than or equal to New York Heart Association Class III.
. Unstable angina pectoris, myocardial infarction or stroke within 6 months before of the first administration of the study drug.

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 1: Number of participants with dose-limiting toxicities (DLTs)

Timeframe: At the end of Cycle 1 (21 days)

Part 1 and Part 2: Number of participants with adverse events (AEs), adverse events of interest (AEIs), and serious adverse events (SAEs)

Timeframe: Up to 50 months

Number of participants with any clinically significant clinical laboratory test value

Timeframe: Up to 50 months

Number of participants with any clinically significant vital sign value

Timeframe: Up to 50 months

Change from Baseline in arterial oxygen saturation

Timeframe: Baseline; up to 50 months

Change from Baseline in body weight

Timeframe: Baseline; up to 50 months

Number of participants with any clinically significant 12-lead electrocardiogram (ECG) value

Timeframe: Up to 50 months

Trial details

NCT IDNCT03386942

SponsorEisai Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-26

View on ClinicalTrials.gov More Solid Tumors trials

Who can participate

Age range

20 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

. Hemoglobin \>=9.0 grams per deciliter (g/dL).
. Neutrophil count \>=1.5 × 10\^3/microliters (μL).
. Platelet count \>=10 × 10\^4/μL.
. Total bilirubin \<=1.5 × upper limit of normal (ULN) in the facility.
. Alanine aminotransferase and aspartate aminotransferase \<=3.0 × ULN in the facility (in the case of liver metastases \<=5\*ULN).
. Serum creatinine \<=1.5 × ULN in the facility.
. Albumin \>=3 g/dL.
. At least 1 lesion of \>=1.0 centimeters (cm) in the longest diameter for a non-lymph node or \>=1.5 cm in the short-axis diameter for a lymph node that is measurable according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 using computerized tomography/magnetic resonance imaging.

Exclusion criteria

. Congestive heart failure greater than or equal to New York Heart Association Class III.
. Unstable angina pectoris, myocardial infarction or stroke within 6 months before of the first administration of the study drug.

What they're measuring

Part 1: Number of participants with dose-limiting toxicities (DLTs)

Timeframe: At the end of Cycle 1 (21 days)

Part 1 and Part 2: Number of participants with adverse events (AEs), adverse events of interest (AEIs), and serious adverse events (SAEs)

Timeframe: Up to 50 months

Number of participants with any clinically significant clinical laboratory test value

Timeframe: Up to 50 months

Number of participants with any clinically significant vital sign value

Timeframe: Up to 50 months

Change from Baseline in arterial oxygen saturation

Timeframe: Baseline; up to 50 months

Change from Baseline in body weight

Timeframe: Baseline; up to 50 months

Number of participants with any clinically significant 12-lead electrocardiogram (ECG) value

Timeframe: Up to 50 months