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

NCT00969553 | Completed Phase 1 Results

• 1 other identifier: 1230.16
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib

  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.

  From first administration of study drug up to 3 weeks

• MTD of Volasertib

  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.

  From the first administration of study drug up to 3 weeks

Secondary Outcomes (15)

• Percentage of Participants With Incidence and Intensity of Drug-related AEs According to CTCAE v.3.0

  From first administration of volasertib to 21 days after the last dose, up to 548 days

• Change From Baseline to Last Value on Treatment in Platelets

  Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)

• Change From Baseline to Last Value on Treatment in Neutrophils

  Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)

• Patient Performance

  From first administration of volasertib to the last dose, up to 527 days

• Vital Signs (Blood Pressure)

  Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days)

Study Arms (1)

BI 6727

EXPERIMENTAL

Schedule A

Drug: BI 6727

Interventions

BI 6727 DRUG

Dose level 1

BI 6727

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1230.16.886002 Boehringer Ingelheim Investigational Site

Tainan, Taiwan

Location

1230.16.886001 Boehringer Ingelheim Investigational Site

Taipei, Taiwan

Location

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: SINGLE GROUP
• 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: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: July 26, 2019
• Results First Posted: July 26, 2019

Record last verified: 2019-05

Locations

TW (2)