Colorectal NeoplasmsPhase 2NCT02198274
Intravenous BIBH 1 in Patients With Metastatic Colorectal Cancer
A Phase 2 study testing BIBH 1 in people with Colorectal Neoplasms, run by Boehringer Ingelheim.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- BIBH 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Feb 2000to Oct 2000
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
About this study
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 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.
- Conditions
- Colorectal Neoplasms
- Being tested
- BIBH 1
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBH 1Drug
Also called Sibrotuzumab
100 mg/week
| Study group | Role | What they receive |
|---|---|---|
| BIBH 1 | Experimental | Not described Receives: Drug: BIBH 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-tumour response
Measured: 4 weeks after the last administration
Secondary outcomes (14)
Time to tumour progression
Measured: up to 16 weeks
Time to loss of response
Measured: up to 16 weeks
Disease progression-free survival time
Measured: up to 16 weeks
Changes in titers of human anti-human antibody (HAHA)
Measured: up to 16 weeks
Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)
Measured: up to 16 weeks
Assessment of the maximum toxicity grade observed for each patient
Measured: up to 16 weeks
Frequency of on-study deaths
Measured: up to 16 weeks
Maximum drug concentration (Cmax)
Measured: up to 16 weeks
Minimum drug concentration (Cmin)
Measured: up to 16 weeks
Area under the concentration-time curve (AUC)
Measured: up to 16 weeks
Total serum clearance (CL)
Measured: up to 16 weeks
Volume of distribution at steady state (Vss)
Measured: up to 16 weeks
Terminal half-life (t1/2)
Measured: up to 16 weeks
Mean residence time (MRT)
Measured: up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2014 (estimated)
- Study startFeb 2000
- Primary completionOct 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02198274
- Sponsor's protocol ID
- 1152.10
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2014
- Last updated
- 23 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02198274
- Acronym / sponsor ID
- 1152.10
- Conditions
- Colorectal Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Feb 2000
- Primary completion
- Oct 2000 (actual)
- First posted
- 23 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BIBH 1 | Experimental | Drug: BIBH 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIBH 1Also: Sibrotuzumab100 mg/week | Drug | BIBH 1 |
Primary outcome
Anti-tumour response
Time frame: 4 weeks after the last administration
14 secondary outcomes
Time to tumour progression
Time frame: up to 16 weeks
Time to loss of response
Time frame: up to 16 weeks
Disease progression-free survival time
Time frame: up to 16 weeks
Changes in titers of human anti-human antibody (HAHA)
Time frame: up to 16 weeks
Incidence and intensity of adverse events graded by Common toxicity criteria (CTC)
Time frame: up to 16 weeks
Assessment of the maximum toxicity grade observed for each patient
Time frame: up to 16 weeks
Frequency of on-study deaths
Time frame: up to 16 weeks
Maximum drug concentration (Cmax)
Time frame: up to 16 weeks
Minimum drug concentration (Cmin)
Time frame: up to 16 weeks
Area under the concentration-time curve (AUC)
Time frame: up to 16 weeks
Total serum clearance (CL)
Time frame: up to 16 weeks
Volume of distribution at steady state (Vss)
Time frame: up to 16 weeks
Terminal half-life (t1/2)
Time frame: up to 16 weeks
Mean residence time (MRT)
Time frame: up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BIBH 1 in people with Colorectal Neoplasms, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti-tumour response (time frame: 4 weeks after the last administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2014.