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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02254005
Recruitment Status : Completed
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: bivatuzumab mertansine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2002
Actual Primary Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: single dose escalation Drug: bivatuzumab mertansine

Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) of bivatuzumab mertansine [ Time Frame: up to day 21 ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to day 21 ]
  2. Number of patients with clinically significant findings in laboratory tests [ Time Frame: up to day 21 ]
  3. Number of patients with clinically significant findings in vital signs [ Time Frame: up to day 21 ]
  4. Tumor response rate [ Time Frame: up to 1 year ]
    assessed by response evaluation criteria in solid tumours (RECIST)

  5. Concentration of bivatuzumab mertansine [ Time Frame: up to day 21 ]
  6. Concentration of CD44v6 recognising IgG antibodies (anti-CD44v6-IgG) [ Time Frame: up to day 21 ]
  7. Number of patients with development of human anti-human antibodies (HAHA) [ Time Frame: up to day 21 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. female patients aged 18 years or older
  2. patients with breast cancer positive for CD44v6 in at least 50 % of the tumour cells
  3. patients with metastases pretreated with anthracyclines and taxanes (unless contraindications to taxanes and / or anthracyclines) or not amenable to established treatments
  4. measurable tumour deposits by one or more radiological techniques (MRI, CT)
  5. life expectancy of at least 6 months
  6. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2
  7. 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:

  1. hypersensitivity to humanised or murine antibodies, immunoconjugates or the excipients of the trial drugs
  2. known secondary malignancy requiring therapy
  3. active infectious disease
  4. brain metastases requiring therapy
  5. neuropathy common toxicity criteria (CTC) grade 2 or above
  6. absolute neutrophil count less than 1,500/mm3
  7. platelet count less than 100,000/mm3
  8. bilirubin greater than 1.5 mg/dl (> 26 μmol/L, système internationale (SI) unit equivalent)
  9. aspartate amino transferase (AST) and/or alanine amino transferase (ALT) greater than 3 times the upper limit of normal
  10. serum creatinine greater than 1.5 mg/dl (> 132 μmol/L, SI unit equivalent)
  11. concomitant non-oncological diseases which are considered relevant for the evaluation of the safety of the trial drug
  12. chemo- or immunotherapy within the past four weeks prior to treatment with the trial drug or during the trial (except for present trial drug)
  13. radiotherapy to breast and thorax region within the past four weeks before inclusion or during the trial
  14. women who are sexually active and unwilling to use a medically acceptable method of contraception
  15. pregnancy or lactation
  16. 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)
  17. patients unable to comply with the protocol
Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02254005    
Other Study ID Numbers: 1191.1
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Bivatuzumab mertansine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological