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Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer

Primary Purpose

Breast Neoplasms

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

bivatuzumab mertansine

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

female patients aged 18 years or older
patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
measurable tumour deposits by one or more radiological techniques (MRI, CT)
life expectancy of at least 6 months
Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation)

Exclusion Criteria:

hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
known secondary malignancy requiring therapy
active infectious disease
brain metastases requiring therapy
neuropathy common toxicity criteria (CTC) grade 2 or above
absolute neutrophil count less than 1,500/mm3
platelet count less than 100,000/mm3
bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
women who are sexually active and unwilling to use a medically acceptable method of contraception
pregnancy or lactation
treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
patients unable to comply with the protocol

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single dose escalation

Arm Description

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) of bivatuzumab mertansine

Secondary Outcome Measures

Incidence of adverse events

Number of patients with clinically significant findings in laboratory tests

Number of patients with clinically significant findings in vital signs

Tumor response rate

assessed by response evaluation criteria in solid tumours (RECIST)

Concentration of bivatuzumab mertansine

Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)

Number of patients with development of human anti-human antibodies (HAHA)

Full Information

NCT ID

NCT02254005

First Posted

September 30, 2014

Last Updated

October 23, 2023

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02254005

Brief Title

Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer

Official Title

An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Female Patients With CD44v6 Positive Metastatic Breast Cancer With Repeated Administration in Patients With Clinical Benefit

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

October 1, 2002 (Actual)

Primary Completion Date

December 1, 2004 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

Maximum tolerated dose (MTD), safety, pharmacokinetics, efficacy of bivatuzumab mertansine

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

single dose escalation

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

bivatuzumab mertansine

Primary Outcome Measure Information:

Title

Maximum tolerated dose (MTD) of bivatuzumab mertansine

Time Frame

up to day 21

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

up to day 21

Title

Number of patients with clinically significant findings in laboratory tests

Time Frame

up to day 21

Title

Number of patients with clinically significant findings in vital signs

Time Frame

up to day 21

Title

Tumor response rate

Description

assessed by response evaluation criteria in solid tumours (RECIST)

Time Frame

up to 1 year

Title

Concentration of bivatuzumab mertansine

Time Frame

up to day 21

Title

Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG)

Time Frame

up to day 21

Title

Number of patients with development of human anti-human antibodies (HAHA)

Time Frame

up to day 21

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: female patients aged 18 years or older patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments measurable tumour deposits by one or more radiological techniques (MRI, CT) life expectancy of at least 6 months Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2 patients must have given written informed consent (which must be consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation) Exclusion Criteria: hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs known secondary malignancy requiring therapy active infectious disease brain metastases requiring therapy neuropathy common toxicity criteria (CTC) grade 2 or above absolute neutrophil count less than 1,500/mm3 platelet count less than 100,000/mm3 bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent) aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent) concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug) radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial women who are sexually active and unwilling to use a medically acceptable method of contraception pregnancy or lactation treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug) patients unable to comply with the protocol

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Links:

URL

http://trials.boehringer-ingelheim.com

Description

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Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer

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