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Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel

NCT02138812 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2018-10-12

No results posted yet for this study

Summary

Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of BAY1161909 in combination with paclitaxel in subjects with advanced malignancies.

Conditions

  • Medical Oncology

Interventions

DRUG

BAY1161909

Given orally, with a starting dose of 0.75 mg twice daily from C1D1 onwards in a 2 days on/5 days off dosing schedule as single agent treatment in Cycle 1 (14 days), and from C2D8 onwards in a 2 days on/5 days off dosing schedule in 28-day cycles. For single-dose PK cohort: a single oral dose on C1D1

DRUG

Paclitaxel

75 mg/m\^2 (initial dose escalation) or 90 mg/m\^2 (second dose escalation), weekly intravenously (IV) infusion on D1, D8, and D15 of the 28-day cycles from C2D1

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-09
Primary Completion
2017-04-28
Completion
2017-10-02
FDA Drug
Yes

Countries

  • United States

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 NCT02138812 on ClinicalTrials.gov