NCT00969761

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 when combined with a platinum therapy (cisplatin or carboplatin). Secondary objectives are the collection of overall safety and antitumour efficacy data and the determination of the pharmacokinetic profile of BI 6727 combination treatment with cisplatin and carboplatin.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2009

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
7 years until next milestone

Results Posted

Study results publicly available

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

August 1, 2018

Enrollment Period

2.3 years

First QC Date

August 31, 2009

Results QC Date

October 23, 2017

Last Update Submit

August 21, 2018

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Maximum Tolerated Dose

    The maximum tolerated dose (MTD) was defined as the highest dose studied for which the incidence of DLT was less than 33% (i.e. 1/6 patients) during the first cycle, for Volasertib in combination with cisplatin or carboplatin. 0=not maximum tolerated dose, 1=was maximum tolerated dose.

    3 weeks

Secondary Outcomes (23)

  • Percentage of Participants With Dose Limiting Toxicities

    3 weeks

  • Objective Response Rate

    From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

  • Duration of Objective Response

    From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

  • Best Overall Response

    From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

  • Disease Control Rate

    From first intake of trial drug to last intake of trial drug plus 21 days, up to 441 days

  • +18 more secondary outcomes

Study Arms (2)

A. BI 6727-cisplatin

EXPERIMENTAL

patient to receive 3-weekly infusion escalating dose of BI 6727 combined to cisplatin

Drug: BI 6727

B. BI 6727-carboplatin

EXPERIMENTAL

patient to receive 3-weekly infusion escalating dose of BI 6727 combined to carboplatin

Drug: BI-6727

Interventions

BI-6727DRUG

Low to high dose (administered every 3 weeks). Depending on the toxicities observed, intermediary dose levels may be added

B. BI 6727-carboplatin
BI 6727DRUG

low to high dose

A. BI 6727-cisplatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Indication for a treatment with platinum therapy as judged by the investigator
  • Age 18 years or older
  • Written informed consent consistent with ICH-GCP and local legislation
  • ECOG performance score lower or equal 2
  • Recovery from CTCAE Grade 2 - 4 therapy-related toxicities from previous systemic anti-cancer therapies or radiotherapies (except alopecia grade 2)

You may not qualify if:

  • Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol
  • Pregnancy or breastfeeding
  • Active infectious disease or known chronic Hepatitis B/Hepatitis C infection and HIV I/II
  • Clinical evidence of symptomatic progressive brain or leptomeningeal disease during the past 6 months
  • Second malignancy currently requiring another anti-cancer therapy
  • ANC less than 1500 / mm3
  • Platelet count less than 100 000 / mm3
  • Bilirubin greater than 1.5 mg / dl (\> 26 micromol / L, SI unit equivalent) (except Gilbert's syndrome)
  • 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)
  • Serum creatinine greater than 1.5 mg / dl (\> 132 micromol / L, SI unit equivalent) or creatinine clearance \<70ml/min (as calculated according to Cockcroft-Gault formula for GFR estimate)
  • Known history of relevant QT-prolongation, e.g. long QT-syndrome
  • Pre-existing clinically relevant hearing loss
  • Women and men who are sexually active and unwilling to use a medically acceptable method of contraception
  • Treatment with other investigational drugs or participation in another clinical interventional trial within the past four weeks before start of therapy or concomitantly with this trial
  • Systemic anti-cancer therapy or radiotherapy within the past four weeks before start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

1230.6.3201 Boehringer Ingelheim Investigational Site

Brussels, Belgium

Location

1230.6.3202 Boehringer Ingelheim Investigational Site

Leuven, Belgium

Location

Related Publications (1)

  • Awada A, Dumez H, Aftimos PG, Costermans J, Bartholomeus S, Forceville K, Berghmans T, Meeus MA, Cescutti J, Munzert G, Pilz K, Liu D, Schoffski P. Phase I trial of volasertib, a Polo-like kinase inhibitor, plus platinum agents in solid tumors: safety, pharmacokinetics and activity. Invest New Drugs. 2015 Jun;33(3):611-20. doi: 10.1007/s10637-015-0223-9. Epub 2015 Mar 22.

    PMID: 25794535DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

BI 6727

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2011

Study Completion

February 1, 2012

Last Updated

January 31, 2019

Results First Posted

January 31, 2019

Record last verified: 2018-08

Locations

BE(2)