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

• Status: Terminated
• Trial end date: 2017-10-02
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• Male or female subjects aged =/> 18 years

• Subjects with advanced, histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy available, or subjects actively refused any standard treatment and / or if, in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.

• For the expansion cohort: women with histologically or cytologically confirmed triple negative breast cancer (TNBC)

• Subjects must have evaluable or measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

• Life expectancy of at least 12 weeks

• Adequate bone marrow, liver, and renal functions

Exclusion Criteria:

• Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study

• Evidence of peripheral neuropathy of Grade > 2

• History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class > II, unstable angina (anginal symptoms at rest), new-onset angina (within the past 3 months before study entry), myocardial infarction within the past 3 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted)

• Prior treatment with more than 3 lines of cytostatic therapies for metastatic disease unless specifically agreed between investigator and sponsor. Subjects with a history of any prior Grade =/> 3 toxicity associated with taxane treatment will be excluded.

• Uncontrolled hypertension defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg, despite optimal medical management

• Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C

• History of human immunodeficiency virus (HIV) infection.