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Phase I Study of BI 831266 in Patients With Advanced 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. Identifier: NCT00756223
Recruitment Status : Completed
First Posted : September 22, 2008
Last Update Posted : November 21, 2013
Information provided by:
Boehringer Ingelheim

Brief Summary:

The main objective of this trial is to provide safety data in terms of drug-related adverse events for the recommendation of the dose for further trials in the development of BI 831266.

Secondary objectives are the collection of antitumour efficacy data and the determination of the pharmacokinetic and pharmacodynamic profile of BI 831266.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Arm A Drug: Arm B Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase I Single Dose Escalation Trial of Two Dosing Schedules of BI 831266 Administered Intravenously Over 24 h Continuously in Patients With Advanced Solid Tumours
Study Start Date : November 2008
Actual Primary Completion Date : October 2010

Arm Intervention/treatment
Experimental: Arm A
BI 831266 24h infusion on day 1 and day 15 every 4 weeks
Drug: Arm A
Dose escalation Arm A (4 weeks)

Experimental: Arm B
BI 831266 24h infusion on day 1 every 3 weeks
Drug: Arm B
Dose escalation Arm B (3 weeks)

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: 3-4 weeks ]

Secondary Outcome Measures :
  1. Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT) [ Time Frame: throughout the study period ]
  2. Pharmacokinetic parameters [ Time Frame: throughout the study period ]
  3. Pharmacodynamic analysis [ Time Frame: 3-4 weeks ]
  4. Efficacy data (progression free survival, objective response rate, response duration) [ Time Frame: throughout the study period ]

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. Patients with confirmed diagnosis of advanced, non-resectable and/or metastatic solid malignant tumours, who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not amenable to established treatment options
  2. Secure central venous access
  3. Measurable and/or non-measurable tumour deposits
  4. Recovery from toxicities of prior anti-cancer therapies at least to CTCAE grade 1
  5. Age >= 18 years
  6. Life expectancy >= 3 months
  7. Written informed consent in accordance with International Conference on Harmonisation guideline for Good Clinical Practice and local legislation
  8. Eastern Cooperative Oncology Group performance score <= 2

Exclusion criteria:

  1. Serious illness, concomitant non-oncological disease (e.g. active infectious disease), or ongoing toxicity of prior therapies considered by the investigator to potentially compromise patients' safety in this trial
  2. Pregnancy or breastfeeding
  3. Symptomatic brain metastases and/or leptomeningeal disease requiring therapy
  4. Second malignancy requiring therapy
  5. Left ventricular ejection fraction (LVEF) < 50% in echocardiography
  6. Clinically significant (i.e. active) cardiovascular disease: CVA/stroke (<= 6 months prior to randomisation), myocardial infarction (<= 6 months prior to randomisation), unstable angina, New York Heart Association Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
  7. Absolute neutrophil count less than 1500 / mm3
  8. Platelet count less than 100 000 / mm3
  9. Bilirubin greater than 1.5 mg / dl (> 26 micromol / L, SI unit equivalent)
  10. 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)
  11. Serum creatinine greater than 1.5 mg / dl (> 132 micromol / L, SI unit equivalent)
  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 in another clinical trial within the past two weeks before start of therapy or concomitantly with this trial
  14. Chemo-, hormone, radio- or immunotherapy within the past two weeks before start of therapy or concomitantly with this trial
  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 identifier (NCT number): NCT00756223

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1257.1.4303 Boehringer Ingelheim Investigational Site
Linz, Austria
1257.1.4302 Boehringer Ingelheim Investigational Site
Salzburg, Austria
1257.1.4301 Boehringer Ingelheim Investigational Site
Wien, Austria
Sponsors and Collaborators
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim Identifier: NCT00756223    
Other Study ID Numbers: 1257.1
2008-001631-36 ( EudraCT Number: EudraCT )
First Posted: September 22, 2008    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: November 2013