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 range20 Years

SexALL

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.
✕. Prolongation of corrected QT (QTc) interval to \> 480 milliseconds (ms) (Fridericia method).
✕. Arrhythmias associated with hemodynamic instability.

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

Change from Baseline in the performance status (PS) score established by the Eastern Cooperative Oncology Group (ECOG)

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 range20 Years

SexALL

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.
✕. Prolongation of corrected QT (QTc) interval to \> 480 milliseconds (ms) (Fridericia method).
✕. Arrhythmias associated with hemodynamic instability.

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

Change from Baseline in the performance status (PS) score established by the Eastern Cooperative Oncology Group (ECOG)