Dose Escalation of BIBF 1120 Combined With Pemetrexed in Advanced Non Small Cell Lung Cancer

NCT02182102 | Completed Phase 1

• 1 other identifier: 1199.18
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective was to determine the safety, tolerability and maximum tolerate dose (MTD) of BIBF 1120 in combination with pemetrexed. Secondary objectives were to characterize the pharmacokinetic profiles of BIBF 1120 and pemetrexed and to obtain preliminary anti-tumour efficacy information.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• MTD (maximum tolerated dose) of BIBF 1120 in combination with pemetrexed (500 mg/m2).

  up to 126 days

• Incidence and intensity of Adverse Events according to the Common Terminology Criteria for Adverse Events (Version 3.0) associated with increasing doses of BIBF 1120.

  up to 126 days

Secondary Outcomes (22)

• AUC0-24 (Area under the plasma concentration-time curve over the dosing interval τ (24 h) following the first dose of uniform intervals τ)

  before and up to 6 hours after adminstration in cycle 2

• AUC0-tz (AUC over the time interval from zero to the time of the last quantifiable drug concentration)

  before and up to 6 hours after adminstration in cycle 2

• AUC0-∞ (AUC over the time interval from zero extrapolated to infinity)

  before and up to 6 hours after adminstration in cycle 2

• %AUCtz-∞ (the percentage of AUC0-∞ that is obtained by extrapolation)

  before and 1, 2, 3, 4, 6 hours after first adminstration in cycle 2

• Cpre,1 (Pre-dose plasma concentration)

  before first administration of BIBF 1120 on day 2 of cycle 2

Study Arms (1)

BIBF 1120 + Pemetrexed

EXPERIMENTAL

Drug: BIBF 1120; Drug: Pemetrexed

Interventions

BIBF 1120 DRUG

BIBF 1120 + Pemetrexed

Pemetrexed DRUG

BIBF 1120 + Pemetrexed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologic confirmation of metastatic, unresectable, or locally advanced NSCLC (non-small cell lung cancer)
• Disease progression during or following one prior platinum-based (including prior neoadjuvant or adjuvant therapy) chemotherapy regimen for advanced disease
• Bi-dimensionally measurable disease by one or more techniques (CT (computed tomography), MRI (magnetic resonance imaging), X-ray)
• Age 18 years or older
• Life expectancy of at least three (3) months
• Eastern Cooperative Oncology Group (ECOG) performance score 0-2
• Written informed consent that is consistent with ICH-GCP (International Conference on Harmonization - Good Clinical Practice) guidelines

You may not qualify if:

• Participation in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study
• Treatment for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of this trial. All toxicities of the previous therapy must have resolved to baseline prior to Treatment Day 1
• Patient has received more than one prior chemotherapy regimen for advanced disease
• Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
• Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation
• Radiotherapy within 4 weeks prior to Treatment Day 1
• Prior treatment with agents that target the vascular endothelial growth factor (VEGF) pathways, including monoclonal antibody therapy (such as bevacizumab) or tyrosine kinase inhibitors
• Active brain metastases (stable for \<28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the criteria above will not be excluded
• Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels, with exception of those tumors which have received prior irradiation and are stable
• Cavitary or necrotic tumors
• Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
• Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
• Gastrointestinal abnormalities that would interfere with intake or absorption (with exception of patients with gastric esophageal reflux disease controlled with proton pump inhibitors) of the study drug, such as a requirement for intravenous alimentation, prior surgical procedures affecting absorption, treatment for peptic ulcer disease within the last 6 months, active gastrointestinal bleeding unrelated to cancer (as evidenced by either hematemesis, hematochezia, or melena in the past 3 months and without endoscopic documented resolution), or malabsorption syndromes
• Significant cardiovascular disease (i.e., uncontrolled hypertension, myocardial infarction within 6 months, unstable angina, serious cardiac arrhythmia, \>2 New York Heart Association (NYHA) Grade 2 congestive heart failure)
• History of hemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months or clinically significant hemoptysis in the past 3 months

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nintedanib; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: September 1, 2005
• Primary Completion: May 1, 2010
• Last Updated: July 18, 2014

Record last verified: 2014-07