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

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ClinicalTrials.gov Identifier: NCT02254031
Recruitment Status : Terminated
First Posted : October 1, 2014
Last Update Posted : October 1, 2014
Sponsor:
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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2003
Actual Primary Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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



Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: up to 14 days after last drug administration ]
    graded according to common toxicity criteria (CTC)

  2. Number of patients with clinically significant findings in laboratory examinations [ Time Frame: up to 14 days after last drug administration ]
  3. Number of patients with clinically significant findings in vital signs [ Time Frame: up to 14 days after last drug administration ]
  4. Number of patients with development of Human Anti-Human Antibody (HAHA) [ Time Frame: up to 14 days after last drug administration ]
  5. Area under the serum concentration time curve from time zero to time point 168 hours (AUC0-168) [ Time Frame: up to 168 hours ]
  6. 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 ]
  7. Area under the serum concentration time curve from time point zero to infinity (AUC0-∞) [ Time Frame: up to 14 days after last drug administration ]
  8. Maximum serum concentration (Cmax) [ Time Frame: up to 14 days after last drug administration ]
  9. Time to reach maximum serum concentration (tmax) [ Time Frame: up to 14 days after last drug administration ]
  10. Terminal elimination half-life (t1/2) [ Time Frame: up to 14 days after last drug administration ]
  11. Mean residence time (MRT) [ Time Frame: up to 14 days after last drug administration ]
  12. Total body clearance (CL) [ Time Frame: up to 14 days after last drug administration ]
  13. Volume of distribution at steady state (Vss) [ Time Frame: up to 14 days after last drug administration ]
  14. Volume of distribution during the terminal elimination phase (Vz) [ Time Frame: up to 14 days after last drug administration ]
  15. Trough concentration at steady state (Cpre,ss) [ Time Frame: up to 7 days after drug administration ]
  16. Minimum serum concentration during the dosing interval τ at steady state (Cmin,ss) [ Time Frame: up to 7 days after drug administration ]
  17. Linearity index (LI) [ Time Frame: up to 14 days after last drug administration ]
  18. Accumulation factor (RA) [ Time Frame: up to 14 days after last drug administration ]
  19. Tumor response [ Time Frame: up to 14 days after last drug administration ]
    according to response evaluation criteria in solid tumours (RECIST)



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

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 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
  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 of 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 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 prior to treatment with the trial drug 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:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02254031     History of Changes
Other Study ID Numbers: 1191.3
First Posted: October 1, 2014    Key Record Dates
Last Update Posted: October 1, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Maytansine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action