Medical Oncology Clinical Trial
Official title:
An Open-label Phase I Dose-escalation Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Maximum Tolerated Dose of Oral BAY1161909 in Combination With Weekly Intravenous Paclitaxel Given in an Intermittent Dosing Schedule in Subjects With Advanced Malignancies
NCT number | NCT02138812 |
Other study ID # | 16804 |
Secondary ID | |
Status | Terminated |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | May 9, 2014 |
Est. completion date | October 2, 2017 |
Verified date | October 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 69 |
Est. completion date | October 2, 2017 |
Est. primary completion date | April 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Tumor response evaluation following RECIST 1.1 criteria | Up to 2 years | ||
Primary | Maximum tolerated dose (MTD) | MTD is defined as the highest dose of oral BAY1161909 (administered in combination with or without IV paclitaxel) that can be given such that not more than 30% of the subjects experience a dose-limiting toxicity (DLT) during Cycles 1 and 2. The safety profile of oral BAY1161909 will first be determined in combination with 75 mg/m^2 IV paclitaxel [MTD (75)]. Starting in >Cohort 7 (12 mg 2 times daily [BID] BAY1161909) the MTD of oral BAY1161909 will then be refined for the combination with 90 mg/m^2 IV paclitaxel [MTD (90)]. | Up to 2 years | |
Primary | Number of subjects with adverse events and serious adverse events as a measure of safety and tolerability. | Up to 2 years | ||
Primary | Plasma concentration of Paclitaxel characterized by Cmax | C2D1 (without oral BAY1161909): pre-dose and 0.5,1,2,3,4,6,8,12,24 (C2D2) & 48hrs (C2D3) after the start of IV infusion on C2D1. C2D8 (with oral BAY1161909): pre-dose and 0.5,1,2,3,4,6, 8,12,24 (C2D9) & 48hrs (C2D10) after the start of infusion on C2D8. | ||
Primary | Plasma concentration of BAY1161909 characterized by Cmax | C1D1 (single-dose PK without IV paclitaxel), C1D2 (multiple-dose PK without IV paclitaxel; no ED on C1D2, MD=Morning Dose, ED= Evening Dose | C1D1: pre-dose & 0.5,1,2,3,4,6,8,12 hrs after the MD on C1D1 [12-hour sample to be collected before administration of the ED]. C1D2: pre-dose & 0.5,1,2,3,4,6,8,12, 24 (C1D3), 48 (C1D4), 72 (C1D5) & 144 hrs (C1D8 pre-dose) after the MD on C1D2. | |
Primary | Plasma concentration of BAY1161909 characterized by Cmax | C2D8 (single-dose PK with IV paclitaxel): pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hours after the morning dose on C2D8 [12-hour sample to be collected before administration of the evening dose]. | ||
Primary | Plasma concentration of BAY1161909 characterized by Cmax | C1D1 (single-dose PK cohort only): pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (C1D2), 48 (C1D3), 72 (C1D4), 96 (C1D5), 168 (C1D8), 240 (C1D11) and 336 hours (before C2D1 IV paclitaxel administration) after the morning dose on C1D1. | ||
Primary | Plasma concentration of BAY1161909 characterized by Cmax | C1D-7 (relative bioavailability assessment subjects): pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 24 (C1D-6), and 72 (C1D-4) hours after the single dose on C1D-7. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02824042 -
Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole
|
Phase 1 | |
Completed |
NCT02253420 -
COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients
|
Phase 1 | |
Completed |
NCT02357953 -
Transpulmonary Thermodilution Using an Implented Central Venous Access Port
|
N/A | |
Completed |
NCT02645357 -
Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients
|
N/A | |
Recruiting |
NCT04931329 -
Onco-haematology Vigilance Card
|
||
Recruiting |
NCT05356182 -
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
|
N/A | |
Terminated |
NCT02368951 -
Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)
|
Phase 1 | |
Not yet recruiting |
NCT05423808 -
Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.
|
N/A | |
Terminated |
NCT02439346 -
Phase I Dose Escalation and Expansion of Oral BAY 1143269 in Combination With Intravenous Docetaxel
|
Phase 1 | |
Recruiting |
NCT05385718 -
Ezra Faster Scan Study
|
||
Completed |
NCT02457351 -
Roniciclib (BAY 1000394) Drug-Drug Interaction (DDI) Study
|
Phase 1 | |
Completed |
NCT02906423 -
Results From a Health System-wide Implementation of a Quality of Life Questionnaire
|
N/A | |
Completed |
NCT01409135 -
A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4
|
Phase 1 | |
Not yet recruiting |
NCT02327806 -
The Effect of Pullsed Magnetic Field Induction on Improving the Forearm Tissue Muscle Performance
|
N/A | |
Completed |
NCT02639091 -
Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors
|
Phase 1 | |
Completed |
NCT02366949 -
Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
|
Phase 1 | |
Not yet recruiting |
NCT06097533 -
Improvement of Quality of Life by Cannabinoids in Oncologic Patients
|
Phase 2/Phase 3 | |
Completed |
NCT02427490 -
A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
|
N/A | |
Recruiting |
NCT05359848 -
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
|
N/A |