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BI 6727 (Volasertib) Monotherapy Phase I Trial in Japanese Patients With Advanced Solid Tumours

NCT01348347 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-08-06

Study results available
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Summary

This open-label phase I dose escalation trial, 1230.15, is the first trial with Volasertib in Japanese advanced cancer patients. The trial will investigate the maximum tolerated dose (MTD), safety, tolerability, and preliminary efficacy of this specific polo-like kinase 1 (Plk1) inhibitor in advanced cancer patients.

Conditions

  • Neoplasms

Interventions

DRUG

Volasertib, low dose, d1q3w

Patient to receive low dose of Volasertib IV

DRUG

Volasertib, middle dose, d1q3w

Patient to receive middle dose of Volasertib IV

DRUG

Volasertib, high dose, d1q3w

Patient to receive high dose of Volasertib IV

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-25
Primary Completion
2012-08-27
Completion
2014-05-15

Countries

  • Japan

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01348347 on ClinicalTrials.gov