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

Boehringer Ingelheim0 sites41 target enrollmentOctober 2006

ConditionsCarcinoma, Non-Small-Cell Lung

InterventionsBI 2536 Pemetrexed

DrugsBI 2536 Pemetrexed

Overview

Phase: Phase 1
Intervention: BI 2536
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Boehringer Ingelheim
Enrollment: 41
Primary Endpoint: Number of patients with adverse events during combination therapy
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

Exploratory evaluation of safety, tolerability, pharmacokinetics (PK), maximum tolerated dose (MTD), and efficacy of BI 2536 administered in combination with pemetrexed

Registry

clinicaltrials.gov

Start Date

October 2006

End Date

February 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

BI 2536 with pemetrexed

combination therapy phase may be followed by BI 2536 monotherapy for eligible patients

Intervention: BI 2536

BI 2536 with pemetrexed

combination therapy phase may be followed by BI 2536 monotherapy for eligible patients

Intervention: Pemetrexed

Outcomes

Primary Outcomes

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

Maximum tolerated dose (MTD) of BI 2536 in combination with pemetrexed

Time Frame: up to 3 weeks

by occurrence of dose limiting toxicities (DLT)

Secondary Outcomes

Duration of objective tumor response after combination therapy(up to 1 year)
Progression free survival (PFS)(up to 2 years)
Overall survival(up to 2 years)
Number of patients with abnormal laboratory findings(up to 20 weeks)
Change in Eastern Cooperative Oncology Group (ECOG) performance score(baseline, up to 1 year)
Objective tumor response after combination therapy(up to 20 weeks)