Weekly Intravenous Administrations of BI 836845 in Japanese Patients With Advanced Solid Tumours

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-11

Study Completion Date

2023-07-14

Brief Summary

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This open-label dose escalation phase I trial, 1280.15, is with the first administration of BI 836845 in Japanese patients with various types of advanced solid tumours. The rationale behind this study is to identify the maximum tolerated dose (MTD) of BI 836845 in Japanese patients with advanced solid tumours as weekly intravenous administration.

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Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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750 milligram Xentuzumab

750 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Group Type EXPERIMENTAL

750 milligram Xentuzumab

Intervention Type DRUG

750 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

1000 milligram Xentuzumab

1000 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Group Type EXPERIMENTAL

1000 milligram Xentuzumab

Intervention Type DRUG

1000 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

1400 milligram Xentuzumab

1400 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Group Type EXPERIMENTAL

1400 milligram Xentuzumab

Intervention Type DRUG

1400 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Interventions

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750 milligram Xentuzumab

750 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Intervention Type DRUG

1000 milligram Xentuzumab

1000 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Intervention Type DRUG

1400 milligram Xentuzumab

1400 milligram Xentuzumab given weekly (days 1, 8, and 15) as an intravenous infusion over 1 hour. Patients stayed on treatment in 21-day cycles until disease progression or undue toxicities.

Intervention Type DRUG

Other Intervention Names

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BI 836845 BI 836845 BI 836845

Eligibility Criteria

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Inclusion Criteria

1. Patients with cytologically or histologically confirmed solid tumours that are refractory to standard therapy, for whom no standard therapy of proven efficacy exists, or who are not amenable to establish treatment options
2. Age \>=20 years old
3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
4. Written informed consent that is consistent with Good Clinical Practice (GCP) guidelines

Exclusion Criteria

1. Active infectious disease to be incompatible with the study treatment
2. Patients who do not have sufficient major organ function and meet any of the following test results at screening period

* Cardiac left ventricular function with resting ejection fraction \<=50% as determined by echocardiography (ECHO) or multiple-gated acquisition scan (MUGA)
* Absolute neutrophil count \<1500/µL
* Platelets \<100 000/µL
* Total bilirubin \>1.5 × the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>2.5 × ULN (in case of known liver metastases, AST and/or ALT \>5 × ULN)
* Creatinine \>1.5 × ULN
* Haemoglobin \<9 g/dL
* HbA1c \>=8% and fasting glucose \>8.9 mmol/L (\>160 mg/dL)
3. Serious illness or concomitant non-oncological disease including severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may compromise the safety of the patient during the study, affect the patient's ability to complete the study, or interfere with interpretation of study results considered by the investigator to be incompatible with the study treatment
4. History of thrombosis (except tumour invading great vessels) within 1 year before start of study treatment or if concurrent anticoagulation required
5. Patients not recovered from any therapy-related toxicities from previous chemotherapies, hormonal therapies, immunotherapies, molecular-targeted therapies, or radiotherapies to Common Terminology Criteria for Adverse Events (CTCAE) grade \<=1
6. Patients who have not recovered from any previous surgery and major surgery within the last 4 weeks before start of study treatment
7. Patients with untreated or symptomatic brain metastases.
8. Patients who have been treated with any of the following within 4 weeks before start of study treatment: chemotherapies, immunotherapies, radiotherapies (within 2 weeks before start of study treatment for local palliative radiotherapies for the treatment of brain metastasis or extremities), biological therapies, molecular-targeted therapies, hormonal therapies for breast cancer within 2 weeks before start of study treatment, or treatment with other investigational drugs.
9. Patients who have used any investigational drug within 4 weeks before start of study treatment or who have planned concomitantly use with the trial.
10. Patients unable to comply with the clinical trial protocol (CTP)

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No