Carcinoma, Non-Small-Cell LungPhase 1NCT02209727
Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 1 study testing 131I-Sibrotuzumab in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim.
Trial summary
Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- 131I-Sibrotuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Jun 2002
- 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
- Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease
- Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable or evaluable disease, determined by World Health Organization (WHO) criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used to determine the extent of the disease
- Expected survival of ≥ 16 weeks
- At least 18 years of age
- Platelet count ≥ 100 x 10**9/L
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- Absolute neutrophil count ≥ 2.0 x 10**9/L
- Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal or < 5 x upper limit of normal if liver metastases are present
- Total bilirubin ≤ 2mg/dL
- Serum creatinine ≤ 2mg/dL
- Ability to provide written informed consent
Who cannot join
- Known brain metastases
- Exposure to an investigational agent within 30 days prior to receiving the scout dose
- Incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection
- Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion. Patients using inhaled corticosteroids are considered eligible for enrollment
- Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131I or sibrotuzumab
- Women who are breast-feeding or pregnant
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- Men and women who were sexually active and are unwilling to utilize a medically acceptable method of contraception
- Hypertrophic skin disease or autoimmune disease that possibly involves over-expression of fibroblast activation protein (FAP), which can be targeted by the antibody. These diseases include active inflammatory arthritis, cirrhosis, and keloids
- Unstable angina pectoris. Patients prescribed medication to control their angina pectoris must have been on a fixed dose for at least 1 month prior to screening to be eligible for trial enrollment
- Myocardial infarction within 3 months prior to screening
- New York Heart Association (NYHA) Heart failure stage III or IV, or a left ventricular ejection fraction of ≤ 40 %
- Impaired lung function, measured by a decrease in forced expiratory volume at one second (FEV1) to less than 50 % of the predicted normal value
About this study
Official title: A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Study to determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- 131I-Sibrotuzumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-SibrotuzumabDrug
50 mg Sibrotuzumab conjugated with 131I
| Study group | Role | What they receive |
|---|---|---|
| 131I-Sibrotuzumab | Experimental | single therapy dose administered over 60 minutes at week 4 Receives: Drug: 131I-Sibrotuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the dose limiting toxicity (DLT)
Measured: up to 12 weeks
Determination of the maximum tolerated dose (MTD)
MTD is defined as the highest dose below which two patients experience DLT
Measured: up to 12 weeks
Occurrence of toxicity
graded according to the Common Toxicity Criteria (CTC)
Measured: up to 12 weeks
Secondary outcomes (1)
Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria
Measured: 8 weeks after therapeutic infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startDec 2000
- Primary completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 9 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
- NCT02209727
- Sponsor's protocol ID
- 1152.6
- Status last verified
- Aug 2014
- First submitted
- 5 Aug 2014
- Last updated
- 6 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Single Dose Escalation Study of 131I-Sibrotuzumab in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02209727
- Acronym / sponsor ID
- 1152.6
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Jun 2002 (actual)
- First posted
- 6 Aug 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 determine the maximum tolerated dose (MTD) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 I isotope.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 131I-Sibrotuzumab | Experimental | Drug: 131I-Sibrotuzumabsingle therapy dose administered over 60 minutes at week 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease
- Eastern cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable or evaluable disease, determined by World Health Organization (WHO) criteria using standard imaging modalities, including ultrasound, X-ray, CT and/or Magnetic Resonance Imaging (MRI). Bone scans and/or antibody scans are not to be used to determine the extent of the disease
- Expected survival of ≥ 16 weeks
- At least 18 years of age
Key exclusion criteria (12 listed)
- Known brain metastases
- Exposure to an investigational agent within 30 days prior to receiving the scout dose
- Incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection
- Treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin C) of the scout infusion. Patients using inhaled corticosteroids are considered eligible for enrollment
- Serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131I or sibrotuzumab
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 |
|---|---|---|
| 131I-Sibrotuzumab50 mg Sibrotuzumab conjugated with 131I | Drug | 131I-Sibrotuzumab |
Primary outcome
Determination of the dose limiting toxicity (DLT)
Time frame: up to 12 weeks
Determination of the maximum tolerated dose (MTD)
Time frame: up to 12 weeks
MTD is defined as the highest dose below which two patients experience DLT
Occurrence of toxicity
Time frame: up to 12 weeks
graded according to the Common Toxicity Criteria (CTC)
1 secondary outcome
Maximum tumor response using the World Health Organisation (WHO) Disease Response Criteria
Time frame: 8 weeks after therapeutic infusion
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 6 Aug 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 131I-Sibrotuzumab in people with Carcinoma, Non-Small-Cell Lung, 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 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 6 Aug 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?
Determination of the dose limiting toxicity (DLT) (time frame: up to 12 weeks). 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 6 Aug 2014.