A Dose Escalation Study of BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer

NCT02182232 | Completed Phase 1

• 1 other identifier: 1199.5
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objectives of this trial were to determine the MTD of BIBF 1120 in combination with carboplatin and paclitaxel, pharmacokinetics and objective response of treatment

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (version 3.0) associated with increasing doses of BIBF 1120

  up to day 126

• Maximum tolerated dose (MTD) of BIBF 1120 in combination with carboplatin and paclitaxel

  up to day 21

Secondary Outcomes (20)

• Pre-dose plasma concentration (Cpre)

  up to day 42

• Objective tumor response according to response evaluation criteria in solid tumors (RECIST)

  up to 12 months

• Time from best response to onset of tumor progression

  Up to 12 months

• Time from start of treatment to time of documented tumor progression

  Up to 12 months

• area under the curve (AUC) from 0 to 12 hours (AUC0-12)

  up to day 42

Study Arms (2)

BIBF 1120 with paclitaxel and carboplatin

EXPERIMENTAL

Drug: BIBF 1120; Drug: Paclitaxel; Drug: Carboplatin

BIBF 1120 monotherapy

EXPERIMENTAL

Drug: Carboplatin

Interventions

BIBF 1120 DRUG

BIBF 1120 with paclitaxel and carboplatin

Paclitaxel DRUG

BIBF 1120 with paclitaxel and carboplatin

Carboplatin DRUG

BIBF 1120 monotherapy; BIBF 1120 with paclitaxel and carboplatin

Eligibility Criteria

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

You may qualify if:

• Male or female patients with histologically or cytologically confirmed Stage IIIB (including pleural effusion), IV or recurrent NSCLC
• Bi-dimensionally measurable disease by one or more techniques (CT, MRI, X-ray)
• Age 18 years or older
• Life expectancy of at least three (3) months
• Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1
• Written informed consent that is consistent with ICH-GCP guidelines

You may not qualify if:

• Prior treatment for NSCLC including chemotherapy, biologic response modifier therapy, or any investigational drug
• Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
• Active brain metastases (stable for \<28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy)
• Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
• Cavitary or necrotic tumors
• Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
• Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
• Radiotherapy within 4 weeks preceding Day 0
• Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
• Gastrointestinal abnormalities that would interfere with intake or absorption 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, ≥NYHA Grade 2 congestive heart failure)
• History of hemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months
• Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months
• Concurrent therapeutic anticoagulation (except heparin flush as needed for maintenance of an indwelling intravenous device) or antiplatelet therapy (except chronic low-dose daily aspirin \<325 mg)
• Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients including Cremophor® (polyoxyethylated castor oil)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nintedanib; Paclitaxel; Carboplatin

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2005
• Primary Completion: May 1, 2007
• Last Updated: July 18, 2014

Record last verified: 2014-07