Lung NeoplasmsPhase 1NCT02199886
Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection
A Phase 1 study testing BIBH 1 in people with Lung Neoplasms, run by Boehringer Ingelheim.
Trial summary
Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in tumour to that of normal tissue in patients with non-small cell lung cancer and to measure human anti-human antibody (HAHA) concentrations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- BIBH 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Jul 1998to Dec 2001
- Phase
- Phase 1
- 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
- Histologically confirmed primary or secondary advanced non-small cell lung cancer
- Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material
- Karnofsky performance status of ≥ 70
- Expected survival of ≥ 3 months
- Greater than or equal to 18 years of age
- Absolute granulocyte count ≥ 2.5 x 10**9/L
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- Lymphocyte count > 0.7 x 10**9/L
- Platelet count ≥ 100 x 10**9/L
- Serum Creatinine ≤ 2.0 mg/dl (0.20 mmol/L)
- Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 3x upper limit of normal
- Total bilirubin < 2 mg/dl or 34µmol (SI unit equivalent)
- Ability to provide written informed consent
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 investigational agent within four weeks of the BIBH 1 infusion
- Patients that are not fully recovered from surgery. Because of the potential binding of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as evidenced by incomplete granulation, infection or localized edema are excluded
- Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for nitrsoureas and/or mitomycin-C.)
- Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment
- Serious illness: e.g., active infections requiring antibiotics, bleeding disorders or diseases considered by the investigator to have potential for interfering with obtaining accurate results from this study
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- Women who are breast-feeding or pregnant
- Men and women of childbearing potential who are unwilling to utilize a medically acceptable method of contraception
- Previous participation in this study
- Patients who have autoimmune disease or hypertopic skin conditions that possibly over-express Fibroblast Activation Protein and may be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis and keloids.
- Patients with unstable angina pectoris. Patients prescribed medication to control their angina pectoris must be on a fixed dose for at least 1 month prior to screening to be eligible for the trial.
- Patients who experienced a myocardial infarction within 3 months of Screening.
About this study
Official title: A Phase I Single Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection
Study to assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in tumour to that of normal tissue in patients with non-small cell lung cancer and to measure human anti-human antibody (HAHA) concentrations.
- Conditions
- Lung Neoplasms
- Being tested
- BIBH 1
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIBH 1Drug
labeled with eight to ten millicurie of 131I
| Study group | Role | What they receive |
|---|---|---|
| BIBH 1 | Experimental | dose escalation: 0.5, 2, 10 or 20mg/m**2, 7 days prior to surgery Receives: Drug: BIBH 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC)
Measured: up to 30 days
Number of patients with abnormal biodistribution for 131I BIBH 1
Measured: up to day 30
Tumor absorbed dose of 131I BIBH 1
Measured: week 2
Secondary outcomes (1)
Concentration of human anti-human antibodies (HAHA)
Measured: up to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startJul 1998
- Primary completionDec 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT02199886
- Sponsor's protocol ID
- 1152.3
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Dose-escalation Study of BIBH 1 in Patients With Non-small Cell Lung Cancer Scheduled for Surgical Resection
- ClinicalTrials.gov ID
- NCT02199886
- Acronym / sponsor ID
- 1152.3
- Conditions
- Lung Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 1998
- Primary completion
- Dec 2001 (actual)
- First posted
- 25 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 assess the toxicity, pharmacokinetics, biodistribution and imaging characteristics associated with increasing doses of 131I-BIBH 1, to compare the uptake of 131I-BIBH 1 in tumour to that of normal tissue in patients with non-small cell lung cancer and to measure human anti-human antibody (HAHA) concentrations.
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 1dose escalation: 0.5, 2, 10 or 20mg/m**2, 7 days prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed primary or secondary advanced non-small cell lung cancer
- Eligible for a lung biopsy or scheduled for surgery that would provide biopsy material
- Karnofsky performance status of ≥ 70
- Expected survival of ≥ 3 months
- Greater than or equal to 18 years of age
Key exclusion criteria (12 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 investigational agent within four weeks of the BIBH 1 infusion
- Patients that are not fully recovered from surgery. Because of the potential binding of BIBH 1 to healing scars, patients with incomplete healing at an incision site, as evidenced by incomplete granulation, infection or localized edema are excluded
- Chemotherapy or immunotherapy within four weeks preceding entry (six weeks for nitrsoureas and/or mitomycin-C.)
- Previous administration of a murine, chimeric or humanised measurement and/or antibody fragment
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 1labeled with eight to ten millicurie of 131I | Drug | BIBH 1 |
Primary outcome
Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC)
Time frame: up to 30 days
Number of patients with abnormal biodistribution for 131I BIBH 1
Time frame: up to day 30
Tumor absorbed dose of 131I BIBH 1
Time frame: week 2
1 secondary outcome
Concentration of human anti-human antibodies (HAHA)
Time frame: up to day 30
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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 1 study testing BIBH 1 in people with Lung 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 12 inclusion and 12 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: stopped early, as of the sponsor's last update on 25 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early. Results are not available in the source record.
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?
Occurrence of dose-limiting toxicities as defined by Common toxicity criteria (CTC) (time frame: up to 30 days). The study lists 3 primary outcomes in all. 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 25 Jul 2014.