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BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

NCT01938846 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-01-04

Study results available
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Summary

The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI 860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs, patients are entered sequentially into escalating dose cohorts. Secondary objectives are objective response and disease control according to RECIST criteria version 1.1

Conditions

  • Neoplasms

Interventions

DRUG

BI 860585

BI 860585 multiple dose escalation, once daily

DRUG

exemestane

exemestane once daily

DRUG

BI 860585

BI 860585 multiple dose escalation, once daily

DRUG

BI 860585

BI 860585 multiple dose escalation, once daily

DRUG

paclitaxel

paclitaxel once weekly

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-05
Primary Completion
2016-07-30
Completion
2017-06-22

Countries

  • Belgium
  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT01938846 on ClinicalTrials.gov