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

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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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 4, 2005
Actual Primary Completion Date : January 19, 2009
Estimated Study Completion Date : August 26, 2022

Arm Intervention/treatment
Experimental: Volasertib Drug: BI 6727



Primary Outcome Measures :
  1. maximum tolerated dose (MTD) as defined by dose limiting toxicity [ Time Frame: 3weeks of first cycle ]

Secondary Outcome Measures :
  1. Tumour response to therapy [ Time Frame: assessed every 6 weeks, average time of 4 months ]
  2. progression free survival [ Time Frame: assessed every 6 weeks, average time of 4 months ]
  3. QTc changes in a subgroup of 14 patients treated at MTD [ Time Frame: 6 weeks (two first cycles) ]
  4. pharmacokinetic parameters: area under the curve 0-24h [ Time Frame: 6 weeks(two first cycles) ]
  5. pharmacokinetic parameters: Maximum concentration [ Time Frame: 6 weeks(two first cycles) ]
  6. pharmacokinetic parameters: termination half life [ Time Frame: 6 weeks(two first cycles) ]


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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 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

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): NCT02273388


Locations
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Belgium
1230.1.32002 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1230.1.32001 Boehringer Ingelheim Investigational Site
Leuven, Belgium
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: NCT02273388     History of Changes
Other Study ID Numbers: 1230.1
2005-002500-42 ( EudraCT Number: EudraCT )
First Posted: October 24, 2014    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: January 2019