Phase I Study of BI 831266 in Patients With Advanced Solid Tumours

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756223
• Other study ID #: 1257.1
• Secondary ID: 2008-001631-36
• Status: Completed
• Phase: Phase 1
• First received: September 19, 2008
• Last updated: November 20, 2013
• Start date: November 2008

Study information

• Verified date: November 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Arm A
Dose escalation Arm A (4 weeks)
• Arm B
Dose escalation Arm B (3 weeks)

Locations

Country	Name	City	State
Austria	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

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		3-4 weeks	Yes
Secondary	Safety parameters (incidence and intensity of AEs graded according to the common terminology criteria for AEs and incidence of DLT)		throughout the study period	Yes
Secondary	Pharmacokinetic parameters		throughout the study period	No
Secondary	Pharmacodynamic analysis		3-4 weeks	No
Secondary	Efficacy data (progression free survival, objective response rate, response duration)		throughout the study period	No