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Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers

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ClinicalTrials.gov Identifier: NCT00969553
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
The primary objective of this trial is to identify the maximum tolerated dose (MTD) of BI 6727 in Asian cancer patients, and to provide safety data in terms of drug-related adverse events.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: BI 6727 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 6727 Administered Intravenously in Asian Patients With Various Solid Cancers With Repeated Administration in Patients With Clinical Benefit
Study Start Date : August 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: BI 6727
Schedule A
Drug: BI 6727
Dose level 1




Primary Outcome Measures :
  1. Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib [ Time Frame: From first administration of study drug up to 3 weeks ]
    Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. The MTD was defined on the basis of DLTs observed during the first treatment course only. In this outcome measure the percentage of participants with DLTs in cycle 1 is presented.

  2. MTD of Volasertib [ Time Frame: From the first administration of study drug up to 3 weeks ]
    Primary objective for this trial was to identify the MTD of volasertib for 2 dosing schedules. The MTD was defined as the highest volasertib dose studied for which the incidence of DLT was less than 2/6 patients. This outcome measure shows the MTD.


Secondary Outcome Measures :
  1. Percentage of Participants With Incidence and Intensity of Drug-related AEs According to CTCAE v.3.0 [ Time Frame: From first administration of volasertib to 21 days after the last dose, up to 548 days ]
    Percentage of participants with incidence and intensity of drug-related AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v.3.0. This endpoint will be presented as a percentage of patients with adverse event by treatment and the highest CTCAE grade of the related AE.

  2. Change From Baseline to Last Value on Treatment in Platelets [ Time Frame: Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days) ]
    This endpoint will be presented as a change from baseline to last value on treatment in platelets.

  3. Change From Baseline to Last Value on Treatment in Neutrophils [ Time Frame: Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days) ]
    This endpoint will be presented as a change from baseline to last value on treatment in neutrophils.

  4. Patient Performance [ Time Frame: From first administration of volasertib to the last dose, up to 527 days ]
    This endpoint will present the best clinical assessment. The investigator will perform a clinical assessment. An evaluation will be done whether the patient appears to be clinically improved, unchanged, or deteriorated. The presented numbers show the percentage of patients.

  5. Vital Signs (Blood Pressure) [ Time Frame: Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days) ]
    This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure SBP and DBP are presented.

  6. Vital Signs (Pulse Rate) [ Time Frame: Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days) ]
    This endpoint will be presented as a change from baseline at last observation of systolic blood pressure (SBP), diastolic blood pressure (DBP) in millimeter of mercury (mmHg) and pulse rate (PR) in beats per minute (bpm). In this outcome measure the pulse rate is presented.

  7. ECG [ Time Frame: Baseline, 2 hours (before the end of infusion of volasertib) and 24 hours after first infusion in Cycle 1 ]
    This endpoint will be presented as a change from individual baseline in QT interval, corrected according to Fridericias formula (QTcF) to end of infusion (2 hours) and 24 hours after first infusion in Cycle 1.

  8. Objective Response [ Time Frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure) ]

    The objective response (OR) was defined as complete response (CR; disappearance of all target lesions) or partial response (PR; at least a 30 percent decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest) assessed by tumour measurement and evaluated according to the Response Evaluation Criteria in solid tumours (RECIST), version 1.0.

    The data represents the percentage of patients.


  9. Progression-free Survival [ Time Frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure) ]
    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death. PFS was assessed by tumour measurement and evaluated according to RECIST, version 1.0.

  10. Response Duration [ Time Frame: From first drug administration up to at 3 month interval after final End of treatment visit until disease progression, death, or lost to follow-up, up to 548 days ]
    The duration of overall response was measured from the time measurement criteria were met for complete response (CR) or partial response (PR), whichever was recorded first, until the first date that recurrent or progressive disease was objectively documented. The duration of overall CR was measured from the time measurement criteria were first met for CR until the first date that recurrent disease was objectively documented.

  11. Disease Control [ Time Frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure) ]
    The disease control (DC) presented are the percentage of patients with CR, PR or stable disease as best response throughout the study assessed by tumour measurement and evaluated according to RECIST, version 1.0.

  12. Sum of the Largest Diameters of Target Lesions [ Time Frame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure) ]
    The individual time profile of the sum of the largest diameters of target lesions (LD) is presented graphically for each patient in the Clinical Trial Report (CTR) only. No descriptive statistics were planned.

  13. Pharmacokinetics (PK) AUC0-∞ of Volasertib [ Time Frame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h ]
    The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-∞ is presented.

  14. Pharmacokinetics (PK) AUC0-168 of Volasertib [ Time Frame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h ]
    The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure AUC0-168 is presented.

  15. Pharmacokinetics (PK) Cmax of Volasertib [ Time Frame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h ]
    The PK of volasertib will be presented for the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) for the population attending the D1 schedule, the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to 168 hours (AUC0-168) for the population attending the D1+ D8 schedule and the maximum measured concentration of volasertib in plasma (Cmax). In this outcome measure Cmax is presented.



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

Inclusion criteria:

  1. Patients with histologically or cytologically confirmed diagnosis of advanced solid cancer
  2. Age 18 years or older
  3. Written informed consent
  4. Eastern Cooperative Oncology Group (ECOG) performance score 2 or less

Exclusion criteria:

  1. Serious illness or concomitant non-oncological disease.
  2. Pregnancy or breast feeding
  3. Active infectious disease
  4. Absolute neutrophil count less than 1,500/cubic millimeter
  5. Platelet count less than 100,000/cubic millimeter
  6. Bilirubin greater than 1.5 mg/dL (> 26 µmol/L, SI unit equivalent)
  7. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal
  8. Serum creatinine greater than 1.5x ULN.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969553


Locations
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Taiwan
1230.16.886002 Boehringer Ingelheim Investigational Site
Tainan, Taiwan
1230.16.886001 Boehringer Ingelheim Investigational Site
Taipei, Taiwan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00969553     History of Changes
Other Study ID Numbers: 1230.16
First Posted: September 1, 2009    Key Record Dates
Results First Posted: July 26, 2019
Last Update Posted: July 26, 2019
Last Verified: May 2019