Clinical trial NCT00969553: Dose Finding Study of BI 6727 (Volasertib) in Patients With Various Solid Cancers
Official title: A Phase I Single Dose Escalation Study of Two Dosing Schedules of BI 6727 Administered Intravenously in Asian Patients With Various Solid Cancers With Repeated Administration in Patients With Clinical Benefit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

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

Exclusion criteria:

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

Primary outcomes:
measure: Percentage of Participants With Dose Limiting Toxicities (DLT) in Cycle 1 for the Determination of the Maximum Tolerated Dose (MTD) of Volasertib
timeFrame: From first administration of study drug up to 3 weeks
measure: MTD of Volasertib
timeFrame: From the first administration of study drug up to 3 weeks
Secondary outcomes:
measure: Percentage of Participants With Incidence and Intensity of Drug-related AEs According to CTCAE v.3.0
timeFrame: From first administration of volasertib to 21 days after the last dose, up to 548 days
measure: Change From Baseline to Last Value on Treatment in Platelets
timeFrame: Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)
measure: Change From Baseline to Last Value on Treatment in Neutrophils
timeFrame: Baseline (Visit 1, prior to first administration of volasertib) and up to 21 days after last observation on treatment (up to 548 days)
measure: Patient Performance
timeFrame: From first administration of volasertib to the last dose, up to 527 days
measure: Vital Signs (Blood Pressure)
timeFrame: Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days)
measure: Vital Signs (Pulse Rate)
timeFrame: Baseline (Visit 1, prior to the first administration of volasertib), up to 21 days after last observation on treatment (up to 548 days)
measure: ECG
timeFrame: Baseline, 2 hours (before the end of infusion of volasertib) and 24 hours after first infusion in Cycle 1
measure: Objective Response
timeFrame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
measure: Progression-free Survival
timeFrame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
measure: Response Duration
timeFrame: From first drug administration up to at 3 month interval after final End of treatment visit until disease progression, death, or lost to follow-up, up to 548 days
measure: Disease Control
timeFrame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
measure: Sum of the Largest Diameters of Target Lesions
timeFrame: At screening and at the end of every other treatment course up to 527 days (= longest treatment exposure)
measure: Pharmacokinetics (PK) AUC0-∞ of Volasertib
timeFrame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h
measure: Pharmacokinetics (PK) AUC0-168 of Volasertib
timeFrame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h
measure: Pharmacokinetics (PK) Cmax of Volasertib
timeFrame: Both schedules: 10 minutes prior to first drug administration and 1 hour (h), 2, 2:30, 3, 4, 8, 24, 336h thereafter; additional planned times in schedule D1+D8: 167:50, 169, 170, 170:30, 171, 172, 176, 192h; additional planned time in D1 schedule: 168h
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: 1230.16.886002 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1230.16.886001 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: