Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Drug: BIBH 1

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BIBH 1	Drug: BIBH 1; 100 mg/week; Other Names: Sibrotuzumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-tumour response	4 weeks after the last administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to tumour progression	up to 16 weeks
Time to loss of response	up to 16 weeks
Disease progression-free survival time	up to 16 weeks
Changes in titers of human anti-human antibody (HAHA)	up to 16 weeks
Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)	up to 16 weeks
Assessment of the maximum toxicity grade observed for each patient	up to 16 weeks
Frequency of on-study deaths	up to 16 weeks
Maximum drug concentration (Cmax)	up to 16 weeks
Minimum drug concentration (Cmin)	up to 16 weeks
Area under the concentration-time curve (AUC)	up to 16 weeks
Total serum clearance (CL)	up to 16 weeks
Volume of distribution at steady state (Vss)	up to 16 weeks
Terminal half-life (t1/2)	up to 16 weeks
Mean residence time (MRT)	up to 16 weeks

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: February 1, 2000
• Primary Completion (ACTUAL): October 1, 2000

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (ESTIMATE): July 23, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 22, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 1152.10