Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer

Colorectal Neoplasms Clinical Trial

Official title:

A Phase II Uncontrolled Sudy to Evaluate the Antitumour Activity and Safety of Intravenous BIBH 1, Administered in a Weekly Dose of 100 mg in 12 Weeks, in Patients With Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198274
• Other study ID #: 1152.10
• Status: Completed
• Phase: Phase 2
• First received: July 22, 2014
• Last updated: July 22, 2014
• Start date: February 2000

Study information

• Verified date: July 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the anti-tumour activity, safety and pharmacokinetics of unlabelled sibrotuzumab administered weekly (seven days +/- one day) at a dose of 100 mg (a total of 12 administrations) in patients with metastatic colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: October 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with metastatic colorectal cancer International Union Against Cancer (UICC) Stage IV who are progressive under at least two previous chemotherapy regimes or who refused conventional treatment or who are not eligible for conventional treatment

• Progressive disease documented by subsequent computed tomography (CT) or magnetic resonance imaging (MRI) scanning prior to study entry. The last CT or MRI scans must be performed within 1 month before study entry. The first CT or MRI scan should be conducted within 6 months before study entry

• Eastern Cooperative Oncology Group (ECOG) performance status of = 2

• Expected survival of = 6 months

• Greater than or equal to 18 years of age

• Platelet count = 100 x 10**9/L

• Total leukocytes = 2500/mm**3

• Alanine aminotransferase/Aspartate aminotransferase (ALT/AST) = 4 x upper limit of normal

• Total bilirubin = 2.0 mg/dl (or 34µmol/L, Systeme International (SI) unit equivalent)

• Serum creatinine = 2.0 mg/dl (0.20 mmol/l)

• Written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria:

• Active metastatic disease to the central nervous system, exhibited by new or enlarging lesions on CT or MRI scan or within 3 months of treatment (i.e., surgery or radiotherapy) for brain metastases

• Exposure to an investigation agent within 30 days prior to the first BIBH 1 infusion

• Patients who are not fully recovered from surgery (incomplete healing)

• Chemotherapy or immunotherapy within 30 days prior to the first BIBH 1 infusion

• Radiation therapy to the symptomatic sites included for tumour measurements within 30 days prior to study entry

• Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment (e.g. BIBH 1, Panorex)

• Serious illness: e.g., active infections requiring antibiotics, bleeding disorders, patients with known untreated or unstable coronary heart disease (e.g. unstable angina or myocardial infarction within 6 months prior to study entry) or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study

• Women who are breast-feeding or pregnant

• Men and women of childbearing potential who are unwilling to utilise a medically acceptable method of contraception

• Patients who suffer from autoimmune diseases

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Drug:
• BIBH 1
100 mg/week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-tumour response		4 weeks after the last administration	No
Secondary	Time to tumour progression		up to 16 weeks	No
Secondary	Time to loss of response		up to 16 weeks	No
Secondary	Disease progression-free survival time		up to 16 weeks	No
Secondary	Changes in titers of human anti-human antibody (HAHA)		up to 16 weeks	No
Secondary	Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)		up to 16 weeks	No
Secondary	Assessment of the maximum toxicity grade observed for each patient		up to 16 weeks	No
Secondary	Frequency of on-study deaths		up to 16 weeks	No
Secondary	Maximum drug concentration (Cmax)		up to 16 weeks	Yes
Secondary	Minimum drug concentration (Cmin)		up to 16 weeks	No
Secondary	Area under the concentration-time curve (AUC)		up to 16 weeks	No
Secondary	Total serum clearance (CL)		up to 16 weeks	No
Secondary	Volume of distribution at steady state (Vss)		up to 16 weeks	No
Secondary	Terminal half-life (t1/2)		up to 16 weeks	No
Secondary	Mean residence time (MRT)		up to 16 weeks	No

External Links

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