Carcinoma, Small CellPhase 2NCT00412880

BI 2536 Second Line Monotherapy in SCLC

A Phase 2 study testing BI 2536 in people with Carcinoma, Small Cell, run by Boehringer Ingelheim at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma, Small Cell
What is being tested?: BI 2536
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 10 sitesin 2 countries
Study dates: 14 Feb 2007to 30 Jun 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.

Who cannot join

More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
Symptomatic brain metastases or leptomeningeal disease
Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin <9 mg/dl
Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine >2.0 mg/dl (>176 µmol/L, SI Unit equivalent)
Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or within less than 4 half-life times of the previous drug prior to treatment with the trial drug

Show all 12Show fewer

Radiation therapy within the past 2 weeks prior to or during treatment with the trial drug
Patients with any serious active infection (i.e., requiring an IV antibiotic, antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection
Known or suspected active drug or alcohol abuse
Treatment with any other investigational drug within the past 4 weeks or within less than 4 half-life times of the investigational drug
Patients with a known pre-existing coagulopathy or requiring therapeutic anticoagulation with warfarin (Coumadin ®)
Patients with neuropathy (sensory or motor) CTCAE 3

Trial locations and contacts

10 sites in 2 countries.

Country

City, postcode or hospital

10 sites in 2 countries

United States9 sites

1216.11.002 Boehringer Ingelheim Investigational Site
Boston, Massachusetts
1216.11.001 Boehringer Ingelheim Investigational Site
Chapel Hill, North Carolina
1216.11.011 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1216.11.003 Boehringer Ingelheim Investigational Site
Chicago, Illinois
1216.11.006 Boehringer Ingelheim Investigational Site
Evanston, Illinois
1216.11.007 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas
1216.11.010 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1216.11.012 Boehringer Ingelheim Investigational Site
Seattle, Washington
1216.11.005 Boehringer Ingelheim Investigational Site
St Louis, Missouri

Other trials in United States

Canada1 site

1216.11.009 Alberta Cancer Board
Edmonton, Alberta

Other trials in Canada

About this study

Official title: An Open-label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 Administered Every 21 Days in Patients With Sensitive Relapse Small Cell Lung Cancer

Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.

Conditions: Carcinoma, Small Cell
Being tested: BI 2536
Medical subject headings: Carcinoma, Small Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 2536Drug
Intravenous Infusion

Study groups in NCT00412880
Study group	Role	What they receive
BI 2536	Experimental	Total Patients Receives: Drug: BI 2536

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Objective Tumor Response
Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).
Measured: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.

Secondary outcomes (6)

Progression Free Survival (PFS)
Progression free survival (PFS) was defined as the duration of time from start of treatment to time of progression (or death any cause). Patients who did not experience progression or death during the trial were censored at the date of last tumor assessment visit at which the patient was evaluated and did not experience progressive disease. Patients who dropped out before any evaluation of response, radiological, clinical, or pathological, were censored at the start of treatment. Progressive Disease (PD) was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
Measured: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Overall Survival
Overall survival (OS) was reported as number of participants with event. Overall survival is the time from first treatment to death. In case there was no occurrence of death or progression during follow-up, the time was censored.
Median survival time was not calculated due to the low number of deaths in the trial.
Measured: From the start of treatment till death or discontinuation, up to 36 weeks.
Duration of Overall Response
The duration of overall objective response (OR) was measured from the time measurement criteria were met for complete response (CR) or partial response (PR) (whichever was first recorded) until the first date that recurrent or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started) or death any cause. OR is defined as either: CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).
Measured: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Occurrence and Intensity of Adverse Events Graded According to CTCAE
Occurrence and intensity of adverse events graded according to common terminology criteria of adverse event (CTCAE) version 3.0.
Measured: From the start of treatment till the last infusion + 21 days, up to 36 weeks.
Number of Participants With Dose Limiting Toxicity
Number of Participants with Dose Limiting Toxicity. Dose limiting toxicity was defined as:
- drug related CTCAE Grade 3 or greater non-hematological toxicity (excluding untreated nausea, vomiting or diarrhea)
- drug related CTCAE Grade 4 neutropenia for 7 or more days or complicated by infection
- CTCAE Grade 4 thrombocytopenia.
Measured: From the start of treatment till the last treatment + 21 days, up to 36 weeks.
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures
Number of participants with an increase in common terminology criteria (CTC) Grade classification for hematological and clinical chemistry laboratory measures. Changes from Baseline in laboratory measures were classified according to CTC Grades 1-4. Results summarizes the number of patients who had a change in laboratory value that represented an increase in CTC Grade classification during the study (based on maximum Grade).
Measured: From the start of treatment till the last treatment + 21 days, up to 36 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 200730 Jun 2008

First posted19 Dec 2006 (estimated)
Study start14 Feb 2007
Primary completion30 Jun 2008
Study completion30 Jun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma, Small CellStudies 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: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00412880
Sponsor's protocol ID: 1216.11
Status last verified: May 2022
First submitted: 18 Dec 2006
Last updated: 22 Jun 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Phase II Trial to Investigate the Efficacy, Safety, and Pharmacokinetics of a Single Dose of 200 mg i.v. BI 2536 Administered Every 21 Days in Patients With Sensitive Relapse Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00412880
Acronym / sponsor ID: 1216.11
Conditions: Carcinoma, Small Cell
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 14 Feb 2007 (actual)
Primary completion: 30 Jun 2008 (actual)
Study completion: 30 Jun 2008 (actual)
First posted: 19 Dec 2006 (estimated)
Results: Posted 31 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in second line treatment in sensitive-relapse SCLC patients.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BI 2536	Experimental	Drug: BI 2536Total Patients

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.
Patients with at least one measurable lesion, with longest diameter to be recorded as 20 mm or greater.
Life expectancy of at least three months and ECOG performance score of 2 or less and written informed consent that must be consistent with ICH-GCP Guidelines.

Key exclusion criteria (12 listed)

More than one prior regimen of chemotherapy, mixed small cell/large cell or combined small cell histology.
Symptomatic brain metastases or leptomeningeal disease
Patients with ascites, patients who have any other life-threatening illness or organ system dysfunction, or other malignancies diagnosed within the past five (5) years (other than non melanomatous skin cancer)
Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin <9 mg/dl
Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine >2.0 mg/dl (>176 µmol/L, SI Unit equivalent)

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
BI 2536Intravenous Infusion	Drug	BI 2536

Primary outcome

Number of Participants With Objective Tumor Response
Time frame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Objective tumor response by investigator was assessed for patients who completed at least two courses of BI 2536 treatment. Tumor images from CT (computed tomography) scan and MRI (magnetic resonance imaging) were evaluated using Response evaluation criteria in solid tumors (RECIST) criteria to determine best tumor response. Objective response (OR) was defined as either: complete response (CR, disappearance of all target lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter).

6 secondary outcomes

Progression Free Survival (PFS)
Time frame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Overall Survival
Time frame: From the start of treatment till death or discontinuation, up to 36 weeks.
Duration of Overall Response
Time frame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.
Occurrence and Intensity of Adverse Events Graded According to CTCAE
Time frame: From the start of treatment till the last infusion + 21 days, up to 36 weeks.
Number of Participants With Dose Limiting Toxicity
Time frame: From the start of treatment till the last treatment + 21 days, up to 36 weeks.
Number of Participants With an Increase in CTC Grade Classification for Hematological and Clinical Chemistry Laboratory Measures
Time frame: From the start of treatment till the last treatment + 21 days, up to 36 weeks.

Results and safety

Results posted to the registry on 31 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI 2536 200 mg	23	0

Primary outcome: Number of Participants With Objective Tumor Response

Time frame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.. Count of participants. Unit: Participants

Measure	BI 2536 200 mg n = 19
Complete response	0
Partial response	0

Population analysed: Treated set (TS): includes all patients who were documented to have taken at least one application of BI 2536. Four patients were excluded from this endpoint due to not having completed two treatment cycles (21 days each).

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the start of treatment till the last treatment + 21 days, up to 36 weeks. All-Cause Mortality was collected from the start of treatment till death or discontinuation, up to 36 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI 2536 200 mg	5 of 23 (21.7%)	21 of 23 (91.3%)	5 of 23

Limitations and caveats (from the sponsor): The criteria for expanding the trial to the second stage were not achieved and the trial was stopped early per trial design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Carcinoma, Small Cell

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
Non-small Cell Lung Cancer
RecruitingPhase 2
Adjuvant ctDNA-Adapted Personalized Treatment in Early Stage NSCLC (ADAPT-E)
Non-small Cell Lung Cancer, Non-small Cell Lung Cancer Stage I
RecruitingPhase 3
A Study Comparing QLC5508 in Combination With QL2107 Versus Tislelizumab Plus Platinum-based Chemotherapy in Participants Wih Treatment-naïve Extensive-Stage Small Cell Lung Cancer
Extensive-stage Small Cell Lung Cancer

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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

10 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 2536 in people with Carcinoma, Small Cell, run by Boehringer Ingelheim at 10 sites in 2 countries.

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 3 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: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 31 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Objective Tumor Response (time frame: Scans during screening (day -28 till day 0) and day 1 of every other (even numbered) 21 day treatment cycle. Up to 40 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00412880.

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 22 Jun 2022.