Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Bivatuzumab mertansine

Maytansine

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Immunotoxins

Immunoconjugates

Immunologic Factors

bivatuzumab mertansine

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

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

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

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

assessed by response evaluation criteria in solid tumours (RECIST)

Boehringer Ingelheim

Symptoms and General Pathology

Recurrence

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

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

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

graded according to common toxicity criteria (CTC)

according to response evaluation criteria in solid tumours (RECIST)

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus

An Open Phase I Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously Once Per Week for Three Weeks in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus With Repeated Administration Courses in Patients With Clinical Benefit

Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck

An Open Phase I Single Dose Escalation Study of Bivatuzumab Mertansine Administered Intravenously in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck With Repeated Administration in Patients With Clinical Benefit

grading according to the common toxicity criteria (CTC)

according to the response evaluation criteria in solid tumours (RECIST)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer	NCT02254005	Breast Neoplasm...	bivatuzumab mer...	18 Years -	Boehringer Ingelheim
Dose Escalation of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Recurrent or Metastatic Breast Cancer	NCT02254031	Breast Neoplasm...	bivatuzumab mer...	18 Years -	Boehringer Ingelheim
Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus	NCT02254044	Carcinoma, Squa...	bivatuzumab mer...	18 Years - 80 Years	Boehringer Ingelheim
Single Dose Escalation Study of Bivatuzumab Mertansine in Female Patients With CD44v6 Positive Metastatic Breast Cancer	NCT02254005	Breast Neoplasm...	bivatuzumab mer...	18 Years -	Boehringer Ingelheim
Single Dose Escalation Study of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck	NCT02254018	Head and Neck N...	bivatuzumab mer...	18 Years -	Boehringer Ingelheim
Dose Escalation of Bivatuzumab Mertansine in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck or Esophagus	NCT02254044	Carcinoma, Squa...	bivatuzumab mer...	18 Years - 80 Years	Boehringer Ingelheim

Spots Global Cancer Trial Database for bivatuzumab mertansine