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Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

BIBH 1

About this trial

This is an interventional treatment trial for Colorectal Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIBH 1

Arm Description

Outcomes

Primary Outcome Measures

Anti-tumour response

Secondary Outcome Measures

Time to tumour progression

Time to loss of response

Disease progression-free survival time

Changes in titers of human anti-human antibody (HAHA)

Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)

Assessment of the maximum toxicity grade observed for each patient

Frequency of on-study deaths

Maximum drug concentration (Cmax)

Minimum drug concentration (Cmin)

Area under the concentration-time curve (AUC)

Total serum clearance (CL)

Volume of distribution at steady state (Vss)

Terminal half-life (t1/2)

Mean residence time (MRT)

Full Information

NCT ID

NCT02198274

First Posted

July 22, 2014

Last Updated

July 22, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT02198274

Brief Title

Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2000 (undefined)

Primary Completion Date

October 2000 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BIBH 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

BIBH 1

Other Intervention Name(s)

Sibrotuzumab

Intervention Description

100 mg/week

Primary Outcome Measure Information:

Title

Anti-tumour response

Time Frame

4 weeks after the last administration

Secondary Outcome Measure Information:

Title

Time to tumour progression

Time Frame

up to 16 weeks

Title

Time to loss of response

Time Frame

up to 16 weeks

Title

Disease progression-free survival time

Time Frame

up to 16 weeks

Title

Changes in titers of human anti-human antibody (HAHA)

Time Frame

up to 16 weeks

Title

Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)

Time Frame

up to 16 weeks

Title

Assessment of the maximum toxicity grade observed for each patient

Time Frame

up to 16 weeks

Title

Frequency of on-study deaths

Time Frame

up to 16 weeks

Title

Maximum drug concentration (Cmax)

Time Frame

up to 16 weeks

Title

Minimum drug concentration (Cmin)

Time Frame

up to 16 weeks

Title

Area under the concentration-time curve (AUC)

Time Frame

up to 16 weeks

Title

Total serum clearance (CL)

Time Frame

up to 16 weeks

Title

Volume of distribution at steady state (Vss)

Time Frame

up to 16 weeks

Title

Terminal half-life (t1/2)

Time Frame

up to 16 weeks

Title

Mean residence time (MRT)

Time Frame

up to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

12. IPD Sharing Statement

Links:

URL

http://trials.boehringer-ingelheim.com

Description

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Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer

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