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Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer

Primary Purpose

Breast Neoplasms

Status

Terminated

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 local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or 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 of 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 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 prior to treatment with the trial drug 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

bivatuzumab mertansine

Arm Description

dose escalation

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD)

Secondary Outcome Measures

Incidence of adverse events

graded according to common toxicity criteria (CTC)

Number of patients with clinically significant findings in laboratory examinations

Number of patients with clinically significant findings in vital signs

Number of patients with development of Human Anti-Human Antibody (HAHA)

Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)

Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)

Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)

Maximum serum concentration (Cmax)

Time to reach maximum serum concentration (tmax)

Terminal elimination half-life (t1/2)

Mean residence time (MRT)

Total body clearance (CL)

Volume of distribution at steady state (Vss)

Volume of distribution during the terminal elimination phase (Vz)

Trough concentration at steady state (Cpre,ss)

Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)

Linearity index (LI)

Accumulation factor (RA)

Tumor response

according to response evaluation criteria in solid tumours (RECIST)

Full Information

NCT ID

NCT02254031

First Posted

September 30, 2014

Last Updated

October 23, 2023

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02254031

Brief Title

Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer

Official Title

An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer With Repeated Administration Courses in Patients With Clinical Benefit

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Terminated

Study Start Date

July 1, 2003 (Actual)

Primary Completion Date

January 1, 2005 (Actual)

Study Completion Date

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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

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

bivatuzumab mertansine

Arm Type

Experimental

Arm Description

dose escalation

Intervention Type

Drug

Intervention Name(s)

bivatuzumab mertansine

Primary Outcome Measure Information:

Title

Maximum tolerated dose (MTD)

Time Frame

up to 6 months

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Description

graded according to common toxicity criteria (CTC)

Time Frame

up to 14 days after last drug administration

Title

Number of patients with clinically significant findings in laboratory examinations

Time Frame

up to 14 days after last drug administration

Title

Number of patients with clinically significant findings in vital signs

Time Frame

up to 14 days after last drug administration

Title

Number of patients with development of Human Anti-Human Antibody (HAHA)

Time Frame

up to 14 days after last drug administration

Title

Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168)

Time Frame

up to 168 hours

Title

Area under the serum concentration time curve from time zero to the time of the last quantifiable drug concentration (AUC0-tz)

Time Frame

up to 14 days after last drug administration

Title

Area under the serum concentration time curve from time point zero to infinity (AUC0-∞)

Time Frame

up to 14 days after last drug administration

Title

Maximum serum concentration (Cmax)

Time Frame

up to 14 days after last drug administration

Title

Time to reach maximum serum concentration (tmax)

Time Frame

up to 14 days after last drug administration

Title

Terminal elimination half-life (t1/2)

Time Frame

up to 14 days after last drug administration

Title

Mean residence time (MRT)

Time Frame

up to 14 days after last drug administration

Title

Total body clearance (CL)

Time Frame

up to 14 days after last drug administration

Title

Volume of distribution at steady state (Vss)

Time Frame

up to 14 days after last drug administration

Title

Volume of distribution during the terminal elimination phase (Vz)

Time Frame

up to 14 days after last drug administration

Title

Trough concentration at steady state (Cpre,ss)

Time Frame

up to 7 days after drug administration

Title

Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss)

Time Frame

up to 7 days after drug administration

Title

Linearity index (LI)

Time Frame

up to 14 days after last drug administration

Title

Accumulation factor (RA)

Time Frame

up to 14 days after last drug administration

Title

Tumor response

Description

according to response evaluation criteria in solid tumours (RECIST)

Time Frame

up to 14 days after last drug administration

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 local and / or regional recurrent disease or distant metastases who are refractory to anthracyclines and / or 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 of 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 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 prior to treatment with the trial drug 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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Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer

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