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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02182232
Recruitment Status : Completed
First Posted : July 8, 2014
Last Update Posted : July 18, 2014
Information provided by (Responsible Party):
Boehringer Ingelheim

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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: BIBF 1120 Drug: Paclitaxel Drug: Carboplatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2005
Actual Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: BIBF 1120 with paclitaxel and carboplatin Drug: BIBF 1120
Drug: Paclitaxel
Drug: Carboplatin
Experimental: BIBF 1120 monotherapy Drug: Carboplatin

Primary Outcome Measures :
  1. 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 ]
  2. Maximum tolerated dose (MTD) of BIBF 1120 in combination with carboplatin and paclitaxel [ Time Frame: up to day 21 ]

Secondary Outcome Measures :
  1. Pre-dose plasma concentration (Cpre) [ Time Frame: up to day 42 ]
  2. Objective tumor response according to response evaluation criteria in solid tumors (RECIST) [ Time Frame: up to 12 months ]
  3. Time from best response to onset of tumor progression [ Time Frame: Up to 12 months ]
  4. Time from start of treatment to time of documented tumor progression [ Time Frame: Up to 12 months ]
  5. area under the curve (AUC) from 0 to 12 hours (AUC0-12) [ Time Frame: up to day 42 ]
  6. AUC from 0 to the last quantifiable drug concentration (AUC0-tz) [ Time Frame: up to day 42 ]
  7. Maximum plasma concentration (Cmax) [ Time Frame: up to day 42 ]
  8. Time to maximum plasma concentration (tmax) [ Time Frame: up to day 42 ]
  9. Rate constant (λz) for BIBF 1120 [ Time Frame: up to day 42 ]
  10. AUC from 0 to 24 hours (AUC0-24) for paclitaxel [ Time Frame: up to day 42 ]
  11. AUC from 0 extrapolated to 48 hours (AUC0-48) for paclitaxel [ Time Frame: up to day 42 ]
  12. AUC from 0 extrapolated to infinity (AUC0-∞) [ Time Frame: up to day 42 ]
  13. Percentage of AUC0-∞ that is obtained by extrapolation (% AUCtz-∞) [ Time Frame: up to day 42 ]
  14. Terminal half-life (t1/2) [ Time Frame: up to day 42 ]
  15. Mean residence time after intravenous administration (MRTiv) for paclitaxel and carboplatin [ Time Frame: up to day 42 ]
  16. Total Clearance (CL/F) [ Time Frame: up to day 42 ]
  17. Volume of distribution during the terminal phase (Vz) [ Time Frame: up to day 42 ]
  18. AUC from 0 to 24 hours (AUC0-24) for carboplatin [ Time Frame: Day 1 and 22 in the treatment time ]
  19. Plasma concentration 21 hours after start of infusion (C21) for carboplatin [ Time Frame: up to day 42 ]
  20. Plasma concentration 24 hours after start of infusion (C24) for paclitaxel [ Time Frame: up to day 42 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Additional Information:
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Responsible Party: Boehringer Ingelheim Identifier: NCT02182232    
Other Study ID Numbers: 1199.5
First Posted: July 8, 2014    Key Record Dates
Last Update Posted: July 18, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors