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

July 17, 2014 updated by: Boehringer Ingelheim

A Phase I Open Label Dose Escalation Study of Continuous Oral Treatment With BIBF 1120 Together With Paclitaxel and Carboplatin in Patients With Advanced Stage Non-small-cell Lung Cancer

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Prior treatment for NSCLC including chemotherapy, biologic response modifier therapy, or any investigational drug
  2. Participation in another clinical study within the past four weeks before start of therapy or concomitantly with this study
  3. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids or antiepileptic therapy)
  4. Centrally located tumors with radiologic evidence (CT or MRI) of local invasion of major blood vessels
  5. Cavitary or necrotic tumors
  6. Sanguinous pleural effusion due to disease or pericardial effusion suspicious for disease
  7. Radiotherapy to an area of measurable disease (unless disease progression had been documented following completion of therapy)
  8. Radiotherapy within 4 weeks preceding Day 0
  9. Other active malignancy diagnosed within the past 3 years (other than non-melanomatous skin cancer)
  10. 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
  11. Significant cardiovascular disease (i.e., uncontrolled hypertension, myocardial infarction within 6 months, unstable angina, serious cardiac arrhythmia, ≥NYHA Grade 2 congestive heart failure)
  12. History of hemorrhagic or thrombotic event (including transient ischemic attacks) in the past 12 months
  13. Clinically significant hemoptysis (1 teaspoon or more) in the past 3 months
  14. 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)
  15. Known hypersensitivity to paclitaxel, carboplatin, or any of their excipients including Cremophor® (polyoxyethylated castor oil)
  16. Absolute neutrophil count (ANC) ≤1,500/μl, platelet count ≤100,000/μl, or hemoglobin <9 gm/dL
  17. Total bilirubin >1.5 mg/dL (26 μmol/L, SI Unit equivalent), alanine amino transferase (ALT) and/or aspartate amino transferase (AST) ≥1.5 X ULN,
  18. Serum creatinine >1.5 mg/dL (>132 μmol/L, SI Unit equivalent)
  19. Persistent hematuria or proteinuria (more than trace)
  20. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  21. Pregnancy or breastfeeding
  22. Known or suspected active alcohol or drug abuse
  23. Patients unable to comply with the protocol

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIBF 1120 with paclitaxel and carboplatin
Drug: Carboplatin
Drug: Paclitaxel
Drug: BIBF 1120
Experimental: BIBF 1120 monotherapy
Drug: Carboplatin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence and intensity of adverse events according to Common Terminology Criteria for Adverse Events (version 3.0) associated with increasing doses of BIBF 1120
Time Frame: up to day 126
up to day 126
Maximum tolerated dose (MTD) of BIBF 1120 in combination with carboplatin and paclitaxel
Time Frame: up to day 21
up to day 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pre-dose plasma concentration (Cpre)
Time Frame: up to day 42
up to day 42
Objective tumor response according to response evaluation criteria in solid tumors (RECIST)
Time Frame: up to 12 months
up to 12 months
Time from best response to onset of tumor progression
Time Frame: Up to 12 months
Up to 12 months
Time from start of treatment to time of documented tumor progression
Time Frame: Up to 12 months
Up to 12 months
area under the curve (AUC) from 0 to 12 hours (AUC0-12)
Time Frame: up to day 42
up to day 42
AUC from 0 to the last quantifiable drug concentration (AUC0-tz)
Time Frame: up to day 42
up to day 42
Maximum plasma concentration (Cmax)
Time Frame: up to day 42
up to day 42
Time to maximum plasma concentration (tmax)
Time Frame: up to day 42
up to day 42
Rate constant (λz) for BIBF 1120
Time Frame: up to day 42
up to day 42
AUC from 0 to 24 hours (AUC0-24) for paclitaxel
Time Frame: up to day 42
up to day 42
AUC from 0 extrapolated to 48 hours (AUC0-48) for paclitaxel
Time Frame: up to day 42
up to day 42
AUC from 0 extrapolated to infinity (AUC0-∞)
Time Frame: up to day 42
up to day 42
Percentage of AUC0-∞ that is obtained by extrapolation (% AUCtz-∞)
Time Frame: up to day 42
up to day 42
Terminal half-life (t1/2)
Time Frame: up to day 42
up to day 42
Mean residence time after intravenous administration (MRTiv) for paclitaxel and carboplatin
Time Frame: up to day 42
up to day 42
Total Clearance (CL/F)
Time Frame: up to day 42
up to day 42
Volume of distribution during the terminal phase (Vz)
Time Frame: up to day 42
up to day 42
AUC from 0 to 24 hours (AUC0-24) for carboplatin
Time Frame: Day 1 and 22 in the treatment time
Day 1 and 22 in the treatment time
Plasma concentration 21 hours after start of infusion (C21) for carboplatin
Time Frame: up to day 42
up to day 42
Plasma concentration 24 hours after start of infusion (C24) for paclitaxel
Time Frame: up to day 42
up to day 42

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1199.5

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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