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BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours

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.
ClinicalTrials.gov Identifier: NCT02273388
Recruitment Status : Active, not recruiting
First Posted : October 24, 2014
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 23, 2014
First Posted Date  ICMJE October 24, 2014
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE November 4, 2005
Actual Primary Completion Date January 19, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
maximum tolerated dose (MTD) as defined by dose limiting toxicity [ Time Frame: 3weeks of first cycle ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
Maximum Tolerated Dose (MTD) [ Time Frame: up to 3 weeks after drug administration ]
Change History Complete list of historical versions of study NCT02273388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
  • Tumour response to therapy [ Time Frame: assessed every 6 weeks, average time of 4 months ]
  • progression free survival [ Time Frame: assessed every 6 weeks, average time of 4 months ]
  • QTc changes in a subgroup of 14 patients treated at MTD [ Time Frame: 6 weeks (two first cycles) ]
  • pharmacokinetic parameters: area under the curve 0-24h [ Time Frame: 6 weeks(two first cycles) ]
  • pharmacokinetic parameters: Maximum concentration [ Time Frame: 6 weeks(two first cycles) ]
  • pharmacokinetic parameters: termination half life [ Time Frame: 6 weeks(two first cycles) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Number of patients with drug-related adverse events [ Time Frame: up to 3 weeks after last drug administration ]
  • Number of patients with clinically significant changes in laboratory evaluations [ Time Frame: up to 3 weeks after last drug administration ]
  • Number of patients with clinically significant changes in electrocardiogram (ECG) [ Time Frame: up to 3 weeks after last drug administration ]
  • Changes in ECOG score [ Time Frame: up to 3 weeks after drug administration ]
  • Tumor response according to response evaluation criteria in solid tumours (RECIST) [ Time Frame: up to 3 weeks after drug administration ]
  • Time to progression [ Time Frame: up to 3 weeks after drug administration ]
  • Number of patients with clinically significant changes in vital signs [ Time Frame: up to 3 weeks after last drug administration ]
  • Cmax (maximum concentration of the analyte in plasma) [ Time Frame: up to 336 hours after drug administration ]
  • tmax (time from dosing to maximum concentration) [ Time Frame: up to 336 hours after drug administration ]
  • AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: up to 336 hours after drug administration ]
  • AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable time point tz) [ Time Frame: up to 336 hours after drug administration ]
  • %AUC0-tz (the percentage of the AUC0-∞ that is obtained by extrapolation) [ Time Frame: up to 336 hours after drug administration ]
  • λz (terminal rate constant in plasma) [ Time Frame: up to 336 hours after drug administration ]
  • t1/2 (terminal half-life of the analyte in plasma) [ Time Frame: up to 336 hours after drug administration ]
  • MRT (mean residence time of the analyte in the body after intravenous administration) [ Time Frame: up to 336 hours after drug administration ]
  • CL (total clearance of the analyte in the plasma after intravascular administration) [ Time Frame: up to 336 hours after drug administration ]
  • Vz (apparent volume of distribution during the terminal phase λz following an intravascular dose) [ Time Frame: up to 336 hours after drug administration ]
  • Vss (apparent volume of distribution at steady state following intravascular administration) [ Time Frame: up to 336 hours after drug administration ]
  • Ae (amount of analyte that is eliminated in urine) [ Time Frame: up to 48 hours after drug administration ]
  • fe (fraction of analyte that is eliminated in urine) [ Time Frame: up to 48 hours after drug administration ]
  • CLR (renal clearance of the analyte) [ Time Frame: up to 48 hours after drug administration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BI 6727 Administered Intravenously Every 3 Weeks in Patients With Solid Tumours
Official Title  ICMJE An Open Phase I Single Dose Escalation Study of BI 6727 Administered Intravenously in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Brief Summary The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 therapy in terms of drug-related adverse events. Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE Drug: BI 6727
Study Arms  ICMJE Experimental: Volasertib
Intervention: Drug: BI 6727
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 23, 2014)
65
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 26, 2022
Actual Primary Completion Date January 19, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Patients with confirmed diagnosis of advanced, non resectable and / or metastatic solid tumours, who have failed conventional treatment, or for whom no therapy of proven efficacy exists, or who are not amenable to established forms of treatment
  2. Age 18 years or older
  3. Written informed consent consistent with ICH-GCP and local legislation
  4. Eastern Cooperative Oncology Group (ECOG, R01-0787) performance score ¿ 2
  5. Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapies (except alopecia)

    The 18 additional patients recruited at the MTD must also meet the following criterion:

  6. Measurable tumour deposits (RECIST) by one or more techniques (CT, MRI)

Exclusion criteria:

  1. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
  2. Pregnancy or breastfeeding
  3. Active infectious disease or known chronic Hepatitis B/Hepatitis C infection
  4. Clinical evidence of active brain or leptomeningeal disease during the past 12 months
  5. Second malignancy currently requiring active therapy
  6. Absolute neutrophil count less than 1500 / mm3
  7. Platelet count less than 100 000 / mm3
  8. Bilirubin greater than 1.5 mg / dl (> 26 ¿mol / L, SI unit equivalent)
  9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
  10. Serum creatinine greater than 1.5 mg / dl (> 132 ¿mol / L, SI unit equivalent)
  11. Known history of relevant QT-prolongation, e.g. long QT-syndrome
  12. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  13. Treatment with other investigational drugs or participation in another clinical trial within the past four weeks before start of therapy or concomitantly with this trial (except for present trial drug)
  14. Chemo-, radio or immunotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
  15. Patients unable to comply with the protocol
  16. Active alcohol or drug abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02273388
Other Study ID Numbers  ICMJE 1230.1
2005-002500-42 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP