Carcinoma, Non-Small-Cell LungPhase 1NCT02211833
Dose Escalation Study of BI 2536 With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer
A Phase 1 study testing BI 2536 and Pemetrexed in people with Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim.
Trial summary
Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed 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?
- BI 2536 and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Feb 2009
- 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
- Pathologic or cytologic confirmed diagnosis of NSCLC
- Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior chemotherapy regimen for advanced disease. Patients could have received prior adjuvant chemotherapy as long as the disease free interval was longer than 1 year.
- Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria
- Male or female aged 18 years or older
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- Written informed consent that was consistent with International Conference on Harmonization (ICH) - Good Clinical Practice (GCP) guidelines
Who cannot join
- Treatment with an investigational drug in another clinical study within the 28 days prior to the start of therapy or concomitantly with this study
- Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the 28 days prior to Day 1 of treatment period 1 of this trial
- Any persisting toxicities that were deemed to be clinically significant from the previous therapy
- Received more than 1 prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients could have received prior epidermal growth factor receptor tyrosine kinase inhibitors
- Unwilling or unable to take folic acid and vitamin B12 supplementation
- Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who had received prior whole brain irradiation and whose brain metastases were stable according to the criteria above were not excluded
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- Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer and cervical intraepithelial neoplasia)
- Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would have limited compliance with trial requirement or which were considered relevant for the evaluation of the efficacy or safety of the trial drug
- Unable or unwilling to interrupt concomitant administration of NSAIDS 5 days prior to the day of and up to 2 days after the administration of pemetrexed
- Received prior therapy with pemetrexed
- Absolute neutrophil count (ANC) ≤1 500/μL, platelet count ≤100 000/μL, or haemoglobin <9 mg/dL
- Total bilirubin >1.5 mg/dL (26 μmol/L), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≥2.5 x the upper limit of normal (ULN), except in cases of known liver metastasis where a maximum 5 x ULN was acceptable
- Serum creatinine level >1.5 mg/dL and or creatinine clearance <45 mL/min
- Sexually active and unwilling to use a medically acceptable method of contraception
- Pregnancy or breast feeding
- Known or suspected active alcohol or drug abuse
- Unable to comply with the protocol
- Any known hypersensitivity to the trial drugs or their excipients
About this study
Official title: A Phase I Open-label Dose Escalation Study of Intravenous BI 2536 Together With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer
Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- BI 2536, Pemetrexed
- 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.
BI 2536Drug
PemetrexedDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 2536 with pemetrexed | Experimental | combination therapy phase may be followed by BI 2536 monotherapy for eligible patients Receives: Drug: BI 2536; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed
by occurrence of dose limiting toxicities (DLT)
Measured: up to 3 weeks
Number of patients with adverse events during combination therapy
according to common terminology criteria for adverse events (CTCAE) 3.0
Measured: up to 20 weeks
Secondary outcomes (6)
Objective tumor response after combination therapy
according to Response Evaluation Criteria in Solid Tumours (RECIST)
Measured: up to 20 weeks
Duration of objective tumor response after combination therapy
Measured: up to 1 year
Progression free survival (PFS)
Measured: up to 2 years
Overall survival
Measured: up to 2 years
Number of patients with abnormal laboratory findings
Measured: up to 20 weeks
Change in Eastern Cooperative Oncology Group (ECOG) performance score
Measured: baseline, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startOct 2006
- Primary completionFeb 2009
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
- 41 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
- NCT02211833
- Sponsor's protocol ID
- 1216.5
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label Dose Escalation Study of Intravenous BI 2536 Together With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02211833
- Acronym / sponsor ID
- 1216.5
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Feb 2009 (actual)
- First posted
- 8 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.
Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed
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 with pemetrexed | Experimental | Drug: BI 2536, Drug: Pemetrexedcombination therapy phase may be followed by BI 2536 monotherapy for eligible patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathologic or cytologic confirmed diagnosis of NSCLC
- Recurrent, advanced or metastatic NSCLC that had progressed following 1 prior chemotherapy regimen for advanced disease. Patients could have received prior adjuvant chemotherapy as long as the disease free interval was longer than 1 year.
- Measurable disease by 1 or more techniques (CT, MRI) according to RECIST criteria
- Male or female aged 18 years or older
- Life expectancy of at least 3 months
Key exclusion criteria (18 listed)
- Treatment with an investigational drug in another clinical study within the 28 days prior to the start of therapy or concomitantly with this study
- Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the 28 days prior to Day 1 of treatment period 1 of this trial
- Any persisting toxicities that were deemed to be clinically significant from the previous therapy
- Received more than 1 prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients could have received prior epidermal growth factor receptor tyrosine kinase inhibitors
- Unwilling or unable to take folic acid and vitamin B12 supplementation
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 2536 | Drug | BI 2536 with pemetrexed |
| Pemetrexed | Drug | BI 2536 with pemetrexed |
Primary outcome
Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed
Time frame: up to 3 weeks
by occurrence of dose limiting toxicities (DLT)
Number of patients with adverse events during combination therapy
Time frame: up to 20 weeks
according to common terminology criteria for adverse events (CTCAE) 3.0
6 secondary outcomes
Objective tumor response after combination therapy
Time frame: up to 20 weeks
Duration of objective tumor response after combination therapy
Time frame: up to 1 year
Progression free survival (PFS)
Time frame: up to 2 years
Overall survival
Time frame: up to 2 years
Number of patients with abnormal laboratory findings
Time frame: up to 20 weeks
Change in Eastern Cooperative Oncology Group (ECOG) performance score
Time frame: baseline, up to 1 year
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 8 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 BI 2536 and Pemetrexed 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 7 inclusion and 18 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 8 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 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?
Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed (time frame: up to 3 weeks). The study lists 2 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 8 Aug 2014.