- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02211833
Dose Escalation Study of BI 2536 With Pemetrexed in Previously Treated Patients With Non-small-cell Lung Cancer
August 7, 2014 updated by: Boehringer Ingelheim
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
41
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BI 2536 with pemetrexed
combination therapy phase may be followed by BI 2536 monotherapy for eligible patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed
Time Frame: up to 3 weeks
|
by occurrence of dose limiting toxicities (DLT)
|
up to 3 weeks
|
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
|
up to 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: up to 2 years
|
up to 2 years
|
|
Objective tumor response after combination therapy
Time Frame: up to 20 weeks
|
according to Response Evaluation Criteria in Solid Tumours (RECIST)
|
up to 20 weeks
|
Duration of objective tumor response after combination therapy
Time Frame: up to 1 year
|
up to 1 year
|
|
Progression free survival (PFS)
Time Frame: up to 2 years
|
up to 2 years
|
|
Number of patients with abnormal laboratory findings
Time Frame: up to 20 weeks
|
up to 20 weeks
|
|
Change in Eastern Cooperative Oncology Group (ECOG) performance score
Time Frame: baseline, up to 1 year
|
baseline, up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
August 7, 2014
First Submitted That Met QC Criteria
August 7, 2014
First Posted (Estimate)
August 8, 2014
Study Record Updates
Last Update Posted (Estimate)
August 8, 2014
Last Update Submitted That Met QC Criteria
August 7, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Folic Acid Antagonists
- Pemetrexed
Other Study ID Numbers
- 1216.5
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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